Life science and biotech careers study living things to improve health, food and the environment. This course shows how biology, chemistry and statistics come together in the lab, what research, clinical and industry labs actually do, and the routes in: technician roles, research degrees, and regulated clinical roles that need ASCP certification and, in some states, a licence. It covers the evidence that gets you hired (lab notebooks, protocols, research experience) and the rules every lab works under: GLP, GMP and CLIA, research ethics and consent, and ALCOA+ data integrity. It builds on STEM Foundations. It teaches knowledge at awareness level; real lab work needs accredited coursework, supervised training and, for clinical roles, certification.

Biology, chemistry, the lab mindset, the regulated routes in, and the rules that govern real labs.

Foundations for Life Science & Biotech Careers

## Why it matters

Life science covers a huge range of work: finding out how a protein folds, testing a patient's blood for infection, growing cells that make a medicine, checking a crop for disease. The careers this course serves (biochemists and biophysicists, biological technicians, and medical laboratory technologists) all sit where several sciences meet. Seeing how they connect helps you choose courses and understand why labs work the way they do.

## How the sciences connect

**Biology** asks how living things work, from whole organisms down to cells and molecules. **Chemistry** explains what those things are made of and how they react: DNA, proteins, lipids and sugars are molecules, and every process in a cell is chemistry. **Physics** explains the instruments (light in a microscope or a spectrophotometer, spinning in a centrifuge) and, in biophysics, the forces that shape molecules. **Statistics** tells you whether a difference you measured is real or just noise.

Put together:

| Question | Main science | Example |
|---|---|---|
| What does this gene do? | Biology (molecular, genetics) | Knock out the gene in cells and watch what changes |
| How does this enzyme speed up a reaction? | Chemistry (biochemistry) | Measure reaction rate at different concentrations |
| How does this protein's shape change? | Physics (biophysics) | Use spectroscopy or imaging to see structure |
| Did the treatment work? | Statistics | Compare treated and control groups with repeats |

**Biotechnology** is the applied side: using living systems (cells, enzymes, microbes) to make products. Insulin made by engineered microbes, many vaccines, enzymes in laundry detergent and diagnostic test kits are all biotech.

## The lab mindset

The technical knowledge matters, but what defines good lab work is a set of habits:

- **Precision.** Measure carefully, use calibrated instruments, and record units and exact amounts.
- **Patience.** Experiments fail often. A cell culture gets contaminated; a reaction does not work. You repeat, troubleshoot and change one thing at a time.
- **Honesty.** Record exactly what happened, including the failures and the odd results. Data that are "tidied up" are not data.
- **Reproducibility.** A result only counts when it can be repeated, by you and by someone else following your notes. That is why labs run **replicates** (repeat measurements) and **controls**.
- **Safety and respect for rules.** Labs work with hazardous chemicals and biological material, so procedures are strict. Following them is part of being a professional.

## A worked example: controls and replicates

A technician wants to know whether a new growth medium makes bacteria grow faster. A careless design grows one plate on the new medium and one on the old, and the new one looks better.

A better design:

1. **Negative control:** a plate with medium but no bacteria, to show the medium itself is not contaminated.
2. **Comparison:** the standard medium, grown in the same incubator at the same temperature for the same time.
3. **Replicates:** three plates of each medium, not one.
4. **Measurement:** count colonies or measure optical density with a spectrophotometer, using the same method for every plate.
5. **Analysis:** compare the averages and the spread. If the three new-medium plates average 210 colonies and the standard plates average 205, with a spread of about 20 within each group, the difference is probably noise.

That last step is where statistics earns its place in the life sciences.

## Common mistakes

- **Treating biology as memorisation only.** Lab work is problem-solving; the facts are tools.
- **Neglecting chemistry and math.** Concentrations, dilutions and statistics appear every day in every lab role.
- **Running one sample and calling it a result.** Without controls and replicates you cannot tell a real effect from chance.
- **Hiding failures.** Failed runs, recorded honestly, are often what solves the problem.

## Quick recap

- Biology asks how life works, chemistry explains the molecules, physics explains instruments and forces, statistics separates signal from noise.
- Biotechnology applies living systems to make products.
- The lab mindset is precision, patience, honesty, reproducibility and safety.
- Controls and replicates turn a single observation into evidence.


Describe how biology, chemistry and statistics connect in life science work, and the habits that make results trustworthy.

Biology, chemistry, and the lab mindset

Biotechnology: Crash Course History of Science #40

The Scientific Method: Crash Course Biology #2

> **Awareness level only.** This lesson explains ideas so you recognise them. It does not train you to work in a lab. Before you handle chemicals, biological samples or lab equipment for real, you need the training your employer or institution requires, and you must work under supervision until they sign you off.


## Why it matters

Every life science lab, whether in a university, a hospital or a biotech company, runs on three things: **safe practice**, **instruments used correctly**, and **records good enough that someone else could repeat the work**. Employers and graduate programs look for all three. This lesson gives you the vocabulary so the first day in a teaching or work lab is less overwhelming.

## Safety at a glance

Labs control risk in layers. You will learn the details in a dedicated lab safety course and, for real, in your institution's training:

- **Know the hazard first.** Every chemical has a **Safety Data Sheet (SDS)** and a labelled container. Read them before use.
- **Engineering controls:** fume hoods for chemical vapours and **biological safety cabinets (BSCs)** for biological samples.
- **Personal protective equipment (PPE):** lab coat, gloves and eye protection at minimum, chosen for the specific hazard.
- **Biosafety levels:** biological work is classified from **BSL-1** (low-risk organisms, such as some strains used in teaching labs) to **BSL-4** (the most dangerous pathogens). Each level adds controls. Teaching labs are usually BSL-1 or BSL-2; clinical labs handle patient samples under BSL-2 practices.
- **Waste:** chemical, biological and sharps waste each go in their own marked containers.

You never start lab work on your own. Your institution trains you, checks you, and supervises you first.

## Core instruments

| Instrument | What it does | Why technique matters |
|---|---|---|
| Micropipette | Measures small liquid volumes (microlitres) | Wrong technique gives wrong volumes in every sample |
| Analytical balance | Weighs to 0.1 mg or better | Drafts and static affect readings; needs regular calibration |
| pH meter | Measures acidity of solutions | Must be calibrated with standard buffers before use |
| Centrifuge | Spins samples to separate components | Must be balanced, or it can be damaged |
| Microscope | Magnifies cells and tissues | Focus, staining and lighting all affect what you see |
| Spectrophotometer | Measures how much light a sample absorbs | Used to measure concentration and cell density |
| Thermocycler (PCR machine) | Cycles temperatures to copy DNA | Programs and sample prep must be exact |
| Autoclave | Sterilises with pressurised steam | Used only after specific training |
| Clinical analysers | Automated tests on blood and body fluids | Run with quality-control samples every day |

A common thread: **instruments only give good data when calibrated, maintained and used as the procedure says.** Labs log calibrations and maintenance for exactly that reason.

## Documentation

If it was not written down, it did not happen. That saying runs every regulated lab. Records include:

- **Lab notebooks:** what you did, when, with what, and what you saw. In research, the notebook is also legal evidence for patents.
- **Standard operating procedures (SOPs):** approved step-by-step instructions everyone follows the same way.
- **Logs:** instrument calibration, freezer temperatures, reagent lot numbers and expiry dates.
- **Electronic systems:** many labs use electronic lab notebooks (ELNs) and a **LIMS** (laboratory information management system) to track samples and results.

## A worked example: a dilution record

A technician prepares 10 mL of a 1 mg/mL solution from a 10 mg/mL stock. The calculation uses C1V1 = C2V2: V1 = (1 mg/mL x 10 mL) / 10 mg/mL = 1 mL of stock, plus 9 mL of buffer. A good record looks like:

```text
2026-10-23 14:05  Prepared 10 mL of 1 mg/mL BSA in PBS.
Stock: BSA 10 mg/mL, lot 4471, exp 2027-03.  Buffer: PBS lot P-220.
1.00 mL stock + 9.00 mL PBS, P1000 pipette #3 (calibrated 2026-09-30).
Labelled tube "BSA 1 mg/mL 23-Oct JS". Stored at 4 C, shelf B.   -- J. Smith
```

Anyone reading this knows what was made, from what, with which equipment, by whom, and where it is.

## Common mistakes

- **Treating PPE as optional for "quick" tasks.**
- **Using an instrument nobody has calibrated** or one you have not been trained on.
- **Recording results later from memory** instead of at the time.
- **Leaving out lot numbers and units.** Problems are often traced to a bad reagent lot.

## Quick recap

- Safety works in layers: know the hazard, use hoods and BSCs, wear PPE, handle waste correctly, and get trained first.
- Know the core instruments and that calibration and technique decide data quality.
- Record what, when, with what and by whom, at the time you do it.


Name the core lab instruments, the basics of lab safety, and why careful records matter.

Lab safety, instruments, and documentation

Lab Tools and Equipment - Know your glassware and become an expert Chemist! | Chemistry

Good Documentation Practices - GDP

## Why it matters

"Working in a lab" means very different things in different places. A university research lab, a hospital clinical laboratory and a biotech manufacturing plant all have pipettes and lab coats, but their goals, pace, rules and career ladders differ. Knowing the differences helps you pick the training that fits the job you want.

## Academic research labs

**Goal:** discover new knowledge and publish it.

- Led by a **principal investigator (PI)**, usually a professor, who wins grants (for example from NIH or NSF in the US) to fund the work.
- Staffed by graduate students, postdoctoral researchers, research technicians and undergraduates.
- Work is exploratory: experiments are designed, fail, get redesigned. Projects run for months or years.
- Output: papers, conference posters, datasets, sometimes patents.
- Rules: institutional safety and biosafety committees, ethics review for human or animal work (Module 3), and good record-keeping. Most academic research is **not** run under GLP or GMP.

**Typical roles:** research technician (bachelor's), lab manager, and, with a PhD, independent researcher. The **biochemist and biophysicist** career usually leads here or to industry R&D.

## Clinical (hospital and reference) labs

**Goal:** produce accurate, timely test results that doctors use to diagnose and treat patients.

- Found in hospitals, reference labs and public health labs.
- Departments include **clinical chemistry** (glucose, electrolytes, enzymes), **hematology** (blood counts), **microbiology** (identifying infections and antibiotic susceptibility), **blood bank / transfusion medicine** (matching blood for transfusion) and **molecular diagnostics** (PCR tests).
- Work is high-volume and often runs 24/7. **Turnaround time** matters: an emergency department may need a result within an hour.
- Every run includes **quality control** samples, and results go into the patient record through the lab information system.
- Rules: in the US, labs testing human specimens for patient care are regulated under **CLIA**, and many are also accredited (for example by CAP). Staff qualifications are regulated; many roles need **ASCP** certification and some states require a licence (Module 2).

**Typical roles:** medical laboratory technician (MLT, associate degree) and **medical laboratory scientist / technologist** (MLS, bachelor's plus an accredited program).

## Industry (biotech and pharma) labs

**Goal:** develop and make products (medicines, diagnostics, enzymes, agricultural products) and prove they are safe and consistent.

- **R&D labs** resemble academic research, but aim at a product and a business deadline.
- **Quality control (QC) labs** test raw materials and finished batches against specifications.
- **Manufacturing** grows cells or microbes at scale in bioreactors.
- Rules: **GMP** for manufacturing and QC, **GLP** for certain safety studies submitted to regulators (Module 3). Everything follows written SOPs; deviations are investigated.

**Typical roles:** **biological technician**, QC analyst, manufacturing associate, research associate, scientist (often with an advanced degree).

## Side-by-side

| | Research | Clinical | Industry |
|---|---|---|---|
| Main goal | New knowledge | Patient results | Safe, consistent products |
| Pace | Project-driven | Fast, around the clock | Schedule- and batch-driven |
| Key rules (US) | Institutional safety and ethics | CLIA, accreditation, personnel rules | GMP, GLP |
| Who decides the method | PI and team | Validated test procedures | Approved SOPs |
| Typical entry | Bachelor's (technician) | MLT/MLS program + ASCP | Associate or bachelor's |

## A worked example: one sample type, three labs

A blood sample means something different in each place. In a **research** lab it might be part of a study on how a protein changes with age, under an approved protocol with consent. In a **clinical** lab it is a patient's specimen, tested on a validated analyser with QC, and the result goes to a doctor within hours. In an **industry** lab, it might be used to validate a new diagnostic test kit under GMP and design-control rules before the kit is sold.

## Common mistakes

- **Assuming a biology degree qualifies you for clinical work.** Clinical roles usually need an accredited program and certification.
- **Thinking industry is just research with more money.** Much industry work is QC and manufacturing under strict procedures.
- **Overlooking public health and government labs**, which offer stable careers in testing and surveillance.

## Quick recap

- Research labs aim to discover and publish; clinical labs produce patient results quickly and accurately; industry labs develop and make products consistently.
- Each has its own rules: institutional oversight, CLIA, or GMP/GLP.
- Pick your training to match the lab type you want to work in.


Compare the goals, pace and rules of academic research, hospital clinical, and biotech industry labs.

Research, clinical, and industry labs

What Are the Differences Between a Research Lab & a Hospital Lab?

Behind the scenes: Medical Laboratory Scientist

Biology, chemistry, the lab mindset, core instruments, and the kinds of labs.

How Life Science Works

## Why it matters

Life science careers have routes at every level, from a two-year technician job to a research PhD. Some are **regulated**: you cannot legally do the job without a specific credential. Choosing the wrong program can cost years, so map the route to your target job *before* you enrol. Requirements change and differ by state, so always confirm them with the official bodies linked below.

## Biological technician

Biological technicians set up and run experiments, prepare samples and media, operate instruments, record data and maintain equipment in research, industry, agriculture and public health labs.

- **Typical education:** a bachelor's degree in biology or a related field is the most common entry; some employers hire with an associate degree in biotechnology plus hands-on lab training.
- **What matters most:** real lab coursework and supervised lab hours. A transcript full of lecture courses with no labs is a weak application.
- **On the job:** industry employers train you in **GMP** and their own SOPs. Optional certificates (for example from community college biotech programs) can help.

## Biochemist and biophysicist

Biochemists and biophysicists study the chemistry and physics of living things: proteins, DNA, enzymes, membranes.

- **Bachelor's** (biochemistry, chemistry, biology, physics) qualifies you for **technician and research associate** roles.
- **PhD** is typical for leading independent research in universities, government and industry R&D. Most PhD programs in the sciences in the US are funded (tuition waiver plus a stipend), which makes them more accessible than many people assume.
- Many go on to postdoctoral research before permanent positions.

## Medical laboratory technologist / scientist (MLS)

Medical laboratory scientists perform and validate the tests doctors rely on. Because patient health depends on the result, this is the most regulated route in this course.

- **Education:** a bachelor's degree plus completion of an **accredited MLS program** that includes **clinical rotations** in a working hospital lab. Programs are accredited by **NAACLS** (National Accrediting Agency for Clinical Laboratory Sciences). Some programs are built into a four-year degree; others are a one-year post-bachelor's certificate.
- **Certification:** most employers require **MLS(ASCP)**, the certification from the **ASCP Board of Certification (BOC)**. There are several eligibility routes (education plus program, or education plus experience); read them on the ASCP site.
- **Medical laboratory technician (MLT):** an associate-degree route with its own accredited programs and the **MLT(ASCP)** certification. Many MLTs later complete a bachelor's and move up to MLS.
- **State licensure:** a minority of US states (for example California, New York and Florida) also require a state licence to work in a clinical lab. If you plan to work in one of them, check its rules early, because some require specific coursework or training.

Official sources:

- ASCP Board of Certification: [ascp.org/boc](https://www.ascp.org/content/board-of-certification). Checked on 2026-10-23.
- NAACLS program search: [naacls.org](https://www.naacls.org). Checked on 2026-10-23.
- Your state's health department or clinical laboratory personnel board, for licensure.

## A worked example: three people, three routes

- **Ana** likes hands-on bench work and wants a job quickly. She completes a bachelor's in biology with three lab-heavy electives and a summer research placement, and is hired as a biological technician at a vaccine manufacturer, where she is trained in GMP.
- **Ben** loves protein structure. He completes a biochemistry BS, works two years as a research technician, then enters a funded PhD program.
- **Chloe** wants to work in a hospital. She chooses a university whose MLS program is NAACLS-accredited, completes clinical rotations in her final year, passes the MLS(ASCP) exam, and applies for her state licence because her state requires one.

## Common mistakes

- **Assuming any biology degree leads to hospital lab work.** Without an accredited MLS program (or an approved alternative route), you may not be eligible for certification.
- **Not checking state licensure** before moving or applying.
- **Skipping lab courses** to raise a GPA. Employers hire for lab skills.
- **Thinking a PhD is required for every science job.** Most lab jobs are technician, associate and QC roles.

## Quick recap

- Biological technician: bachelor's (sometimes associate) with real lab hours; GMP training on the job.
- Biochemist/biophysicist: bachelor's for technician and associate roles; PhD for independent research.
- Medical laboratory scientist: NAACLS-accredited program with clinical rotations, MLS(ASCP) certification, and a state licence where required.
- Confirm requirements with ASCP, NAACLS and your state, because they change.


Map the degree, ASCP certification and state licensure routes for technician, research and clinical lab careers.

Degrees, certifications, and regulated roles

How do I apply for ASCP BOC Certification?

What Can You Do With Your Biology Degree? (Psst! You Don't Need to Be Pre-Med!) | College & Careers

Use a bound notebook or a stapled booklet with numbered pages, and a pen (not a pencil).

Start the entry with the date, an entry title, a page number and your name.

Write the objective in one sentence and list every material with details (brand, when bought, scale resolution, approximate water temperature).

Write the procedure as numbered steps detailed enough that someone else could repeat it exactly, including how many replicates (at least 3 per condition).

Draw a data table with units in the headers before you start, then record each result as you measure it.

Make at least one correction the professional way: a single line through the error, the correct value next to it, and your initials and date.

Record any observations or problems honestly (a torn sheet, an interruption), even if they make the data look less tidy.

Calculate the average for each condition, write a two-sentence conclusion and a next step, line through any blank space, and sign the entry.

## Why it matters

When a lab hires a technician or accepts a research student, the question is: **can this person do careful, documented work?** Grades help, but evidence helps more: a clean notebook, protocols you have written or followed, and experience in a real lab. This lesson shows what professional records look like so you can start practising the habits now.

## The lab notebook

A lab notebook is the permanent, chronological record of your work. In research it supports publications and patents; in regulated labs it is part of the legal record. Traditional rules (your lab or employer will give you its own):

- A **bound notebook** with numbered pages, or an approved electronic lab notebook (ELN). No loose sheets.
- Write in **permanent ink**, at the time you do the work.
- Every entry has a **date**, a **title** and your **name or initials**.
- Record the **objective**, **materials** (with lot numbers and concentrations), **procedure** (or a reference to the protocol and any changes), **observations and raw data** with units, and a short **conclusion or next step**.
- **Never erase or use correction fluid.** Cross out an error with a single line so it stays readable, then initial, date and (if useful) explain it.
- Do not leave blank gaps; line through unused space.
- **Sign** the entry. In some labs, a colleague also signs as witness.

## Protocols

A **protocol** (or SOP in regulated labs) is a step-by-step procedure detailed enough that a trained colleague gets the same result. A good protocol lists purpose, safety notes, materials and equipment, numbered steps with exact amounts, times and temperatures, and how to record results. When you deviate from a protocol, you record the deviation and why.

## Getting experience

- **Course labs** are your first evidence; keep your best lab reports.
- **Undergraduate research**: volunteer or paid positions in a faculty lab, often found by emailing PIs (next lesson).
- **Summer programs**: many universities and government agencies run paid summer research programs for undergraduates (in the US, search for NSF REU sites and NIH summer programs).
- **Industry internships and co-ops** at biotech, pharma, food and agricultural companies.
- **Hospital lab assistant or specimen processor jobs**, which are a common first step toward clinical lab careers.
- **Posters and short reports** from any of these show you can communicate science.

## A worked example: a notebook entry from a kitchen experiment

You can practise notebook skills with a completely safe test at home, such as comparing how much water two paper towel brands absorb.

```text
2026-10-23   Entry 7: Paper towel absorbency comparison        p. 14
Objective: Compare water absorbed by one sheet of Brand A vs Brand B.
Materials: Brand A (pack bought 2026-10-20), Brand B (pack bought 2026-10-20),
  tap water ~20 C, kitchen scale (0.1 g), 250 mL measuring jug, timer.
Procedure: Weigh dry sheet. Submerge 10 s. Hold up to drip 30 s. Reweigh.
  Water absorbed = wet mass - dry mass. 3 sheets per brand.
Data (g):        dry   wet   absorbed
  A1             2.1   18.4  16.3
  A2             2.0   17.9  15.9
  A3             2.1   ~~18.8~~ 18.6 (misread, JS 23-Oct)  16.5
  B1 ...
Observations: B sheets tore when lifted (B2 tore; result kept, noted).
Conclusion: A mean 16.2 g. Next: repeat with 5 sheets each.      Signed: J. Smith
```

Notice the single-line correction with initials and date, the units, the replicate count, and the honest note about a torn sheet.

## Common mistakes

- **Writing up notes later** from memory or scrap paper.
- **Missing units, lot numbers or dates.**
- **"Fixing" data** by deleting odd results instead of recording and explaining them.
- **Vague procedures** like "mixed some buffer". Someone else must be able to repeat your work.

## Quick recap

- A notebook entry is dated, titled, signed, written at the time, in ink, with materials, procedure, raw data with units, and a conclusion.
- Corrections are single-line cross-outs with initials and date; nothing is erased.
- Protocols must be repeatable by a trained colleague; deviations are recorded.
- Build evidence through course labs, research positions, summer programs, internships and hospital lab assistant roles.

## Try it

Open the **Do** tab and write a full notebook entry for a safe kitchen test.


Keep a lab-notebook entry to a professional standard, and know what evidence gets you into a lab.

Evidence: lab notebooks, protocols, and internships

Keeping a Laboratory Notebook

Ten Tips For Keeping a Better Lab Notebook

List 5 possible opportunities: at least 3 faculty labs (from a university near you or your own school), plus one formal program (for example an NSF REU site or a hospital lab assistant posting).

For your top choice, read the lab or program page and one recent paper abstract or project description. Write two sentences in your own words about what they study.

Write down the skills, courses and hours per week you can honestly offer.

Draft the email using the structure from the lesson: specific subject, who you are, why this lab, what you offer, a small request.

Cut the draft to under 200 words and check the professor's name and title are spelled correctly.

Update or create a one-page resume that lists your lab courses and any lab skills.

Put a reminder in your calendar for a single follow-up 10-14 days after you send it.

## Why it matters

Most first lab positions, especially undergraduate research spots, are never advertised. They go to people who ask, clearly and politely. A short, specific email to the right person is one of the highest-value things a student can write. This lesson shows where to look and how to write that email.

## Where opportunities come from

- **Faculty research labs.** Browse your department's faculty pages. Read each lab's research summary and one recent paper abstract. Make a list of 5-10 labs whose work genuinely interests you.
- **Formal programs.** Many universities have undergraduate research offices with paid positions and course credit. In the US, NSF **REU** (Research Experiences for Undergraduates) sites and NIH summer programs fund summer research, often with housing and a stipend.
- **Community colleges.** Biotech programs at community colleges often include internships with local companies.
- **Hospital labs.** Entry roles such as **lab assistant**, **specimen processor** or **phlebotomist** put you inside a clinical lab. Hospital careers pages list them; some MLS programs also offer information sessions.
- **Industry.** Biotech, pharma, food and agricultural companies post internships and co-ops, often on their own careers pages.
- **Public health and government labs.** State public health labs and federal agencies run internships and fellowships.

## Writing the email

Faculty receive many emails. Make yours easy to say yes to:

1. **Subject line:** specific. "Undergraduate interested in your enzyme kinetics research" beats "Research opportunity?".
2. **Who you are:** one sentence: year, major, school.
3. **Why this lab:** one or two sentences showing you read about their work. Mention a specific project or paper in your own words.
4. **What you offer:** relevant courses, lab skills, hours per week you can commit, and when you could start.
5. **The ask:** a short meeting, or whether they have room for an undergraduate.
6. **Attach** a one-page resume. Keep the email under about 200 words.

## A worked example

```text
Subject: Biology sophomore interested in your bacterial biofilm research

Dear Dr. Rivera,

I am a second-year biology major at State University. I read your lab's
page on how biofilms form on medical tubing, and your recent paper on
surface coatings that slow biofilm growth. The idea of preventing
infections through materials design is the reason I chose biology.

I have completed General Biology I-II and General Chemistry I with labs,
where I practised sterile technique, micropipetting and keeping a lab
notebook. I can commit 8-10 hours a week starting in January, and I am
happy to begin with media prep and lab upkeep.

Would you have 15 minutes to meet, or room for an undergraduate this
spring? My resume is attached.

Thank you for your time,
Jordan Lee   (jordan.lee@stateu.edu)
```

It is short, specific, honest about experience level, and makes a small, easy request.

## Following up

- If there is no reply after about one to two weeks, send **one** polite follow-up.
- If a lab says no, ask whether they can suggest another lab. Many positions come through referrals.
- Send emails to several labs (individually written, not copy-pasted with only the name changed).
- If you get a meeting, prepare two or three questions about the work and be ready to describe what you hope to learn.

## Hospital lab applications

For clinical roles, apply through the hospital's careers site. Read the posting for requirements (some need a high-school diploma, some a phlebotomy certificate, some coursework). Mention reliability, attention to detail and comfort with shift work. Ask MLS program staff whether local hospitals host students or offer tours.

## Common mistakes

- **Mass emails** that clearly were not written for that lab.
- **Long emails** with life stories; keep it under a screen.
- **Overstating skills.** Saying you can "run PCR independently" after one class lab sets you up to fail.
- **Giving up after one no.** Rejection is normal; persistence and referrals work.

## Quick recap

- Most first lab positions come from asking: faculty labs, formal programs (REU, NIH summer), hospitals, industry and public health labs.
- Write a short, specific email: who you are, why this lab, what you offer, a small request, resume attached.
- Follow up once, ask for referrals, and apply to several places.

## Try it

Open the **Do** tab to research a lab or program and draft your own email.


Find research and hospital lab opportunities and draft a short, specific email that gets replies.

Finding lab experience

Top 3 tips for getting involved in undergraduate research at Penn State from Janine Kwapis

Degrees, certifications, regulated roles, lab notebooks, and finding experience.

Getting Into the Lab

## Why it matters

Lab job postings are full of acronyms: "GMP experience preferred", "CLIA-certified laboratory", "GLP study support". They name the rule sets that decide how a lab must work, how it is inspected and what its records must show. Knowing which rules apply to which lab tells you what a job will be like and what training you will need. This lesson covers the US framework at awareness level; the regulations themselves are long, change over time, and are taught in detail by employers.

## GLP: Good Laboratory Practice

**What it covers:** non-clinical laboratory studies (often animal or lab studies of toxicity and safety) whose results are submitted to regulators to support approval of products such as drugs, medical devices, food additives and pesticides.

**Who sets it:** in the US, the FDA's GLP regulations are in **21 CFR Part 58**, and the EPA has its own GLP rules for pesticides and chemicals. Internationally, the **OECD** Principles of GLP play the same role.

**What it requires, in outline:**

- A named **study director** responsible for each study.
- An independent **quality assurance unit** that audits studies.
- Written **protocols** and **SOPs**, followed and documented.
- Calibrated, maintained equipment and characterised test materials.
- **Archived raw data** and specimens so a study can be reconstructed years later.

GLP is about the **integrity of a study**. It does not tell scientists which experiments to run.

## GMP: Good Manufacturing Practice

**What it covers:** the manufacture, testing and release of products such as drugs, biologics and medical devices, so every batch is safe and consistent. You will often see "cGMP" (current GMP).

**Who sets it:** FDA regulations, including **21 CFR Parts 210 and 211** for drugs, additional parts for biologics, and quality system rules for medical devices. International guidance comes from ICH and other bodies.

**What it requires, in outline:**

- A **quality unit** with authority to approve or reject materials and batches.
- **Batch records** documenting every step of making each batch.
- **Validated** processes, equipment, methods and cleaning.
- **Change control**: no change to a process without review and approval.
- **Deviations** investigated and **CAPA** (corrective and preventive action) to stop them recurring.
- Training records for every employee.

A biological technician at a vaccine plant or a QC analyst at a pharma company lives in GMP every day.

## CLIA: Clinical Laboratory Improvement Amendments

**What it covers:** US laboratories that test **human specimens** to provide information for the diagnosis, prevention or treatment of disease, or the assessment of health. Hospital labs, reference labs and doctor's office labs fall under CLIA. Research labs that do not report patient-specific results for patient care are generally not covered.

**Who runs it:** **CMS** (Centers for Medicare & Medicaid Services) administers CLIA; **FDA** categorises tests by complexity; **CDC** provides scientific support. Labs hold a CLIA certificate, and many are accredited by an approved organisation such as **CAP** (College of American Pathologists).

**What it requires, in outline:**

- Tests classified as **waived**, **moderate complexity** or **high complexity**, with stricter rules as complexity rises.
- **Quality control** for every test run and **proficiency testing** (blind samples from an outside program).
- **Personnel qualifications** for directors, supervisors and testing staff, which is one reason clinical employers require MLS(ASCP)-level training.
- Inspections, and corrective action when problems are found.

## Which rules apply? A worked example

| Situation | Main rule set |
|---|---|
| A toxicology study in rats to support a new drug application | GLP |
| Filling vials of a vaccine and testing each batch before release | GMP |
| A hospital measuring a patient's potassium level | CLIA |
| A university lab studying how yeast cells divide | None of the three (institutional safety and ethics rules still apply) |
| A clinical trial giving a new drug to patients | GCP (Good Clinical Practice), plus CLIA for any lab testing that supports patient care |

Official sources for detail: FDA ([fda.gov](https://www.fda.gov)), CMS CLIA pages ([cms.gov](https://www.cms.gov)) and the CDC's CLIA resources ([cdc.gov](https://www.cdc.gov)). Regulations and guidance change; read the current versions there. Checked on 2026-10-23.

## Common mistakes

- **Using "GLP" to mean "good lab habits".** In regulated work, GLP is a specific legal framework for safety studies.
- **Assuming research labs follow GMP.** Most academic research does not, which is why industry trains new hires in GMP.
- **Thinking CLIA is only about equipment.** It also covers staff qualifications, QC and proficiency testing.

## Quick recap

- GLP: integrity of non-clinical safety studies submitted to regulators (21 CFR 58).
- GMP: consistent, safe manufacturing and batch release (21 CFR 210/211 for drugs and more).
- CLIA: quality of patient testing on human specimens, run by CMS with FDA and CDC.
- Each requires written procedures, trained staff and records an inspector can check.


Explain which US rules govern which labs: GLP for safety studies, GMP for manufacturing, CLIA for clinical testing.

GLP, GMP, and CLIA

GMP vs GLP vs GCP Difference in 10 Minutes | FDA Compliance Guide

Understanding CLIA and CAP Regulations to Advance Your Laboratory Career

## Why it matters

Life science research often involves people (blood samples, medical records, clinical trials) or animals. History shows what happens when researchers decide for themselves what is acceptable. Today, research involving humans or animals must be reviewed and approved before it starts, and everyone on the team, including technicians and students, must follow the approved protocol. You will complete ethics training before working on such projects; this lesson gives you the background.

## Lessons from history

- **The Nuremberg Code (1947)** came out of the trials of Nazi doctors who experimented on prisoners. Its first principle: the voluntary consent of the human subject is absolutely essential.
- **The US Public Health Service syphilis study at Tuskegee (1932-1972)** followed hundreds of Black men with syphilis without telling them their diagnosis, and withheld effective treatment (penicillin) even after it became standard. Public exposure in 1972 ended the study and led directly to US research protections.
- **Henrietta Lacks (1951).** Cells taken from her tumour at Johns Hopkins without her knowledge became the HeLa cell line, used in countless discoveries. Her family was not told for decades. The case still shapes discussion of consent, privacy and the use of biological samples.

## The Belmont Report's three principles

In 1979 a US national commission published the **Belmont Report**, which still underpins research ethics:

1. **Respect for persons:** treat people as autonomous; get informed consent; protect those with reduced autonomy (children, people with cognitive impairments, prisoners).
2. **Beneficence:** do no harm, and maximise benefits while minimising risks.
3. **Justice:** distribute the burdens and benefits of research fairly; do not target vulnerable groups because they are convenient.

## IRBs and the Common Rule

In the US, most federally funded research with human subjects follows the **Common Rule** (45 CFR 46), and FDA-regulated studies follow FDA's human subject rules. Both require review by an **Institutional Review Board (IRB)**: a committee including scientists, non-scientists and at least one member not affiliated with the institution. The IRB:

- Reviews the protocol before research begins.
- Weighs risks against benefits.
- Checks the consent process and documents.
- Can require changes, approve, or disapprove, and continues oversight while the study runs.

Some low-risk studies qualify for **exempt** or **expedited** review, but the decision belongs to the IRB, not the researcher.

## Informed consent

Consent is a **process**, not just a signature. Participants must be told, in language they understand:

- The purpose, procedures and how long participation lasts.
- Foreseeable risks and discomforts, and possible benefits.
- Alternatives, and how their data and samples will be kept confidential and used.
- That participation is **voluntary** and they can **withdraw at any time** without penalty.
- Whom to contact with questions.

## Animal research: IACUCs and the 3Rs

Research with vertebrate animals at US institutions is reviewed by an **Institutional Animal Care and Use Committee (IACUC)** under the Animal Welfare Act and Public Health Service policy. Researchers must justify the use of animals and follow the **3Rs**:

- **Replace** animals with alternatives (cell culture, computer models) where possible.
- **Reduce** the number of animals to the minimum needed for a valid result.
- **Refine** procedures to minimise pain and distress.

## Research misconduct

Separate from consent, US agencies define research misconduct as **fabrication** (making up data), **falsification** (manipulating data or images) and **plagiarism**. These end careers. Honest error and differences of opinion are not misconduct; hiding errors can become it.

## A worked example

A technician in a lab studying a blood biomarker is asked to "just run a few extra samples" from the freezer for a new side project. The samples were collected under a consent form that covered only the original study. What should happen?

The technician should pause and ask whether the IRB-approved protocol and the consent cover the new use. If not, the PI needs to seek IRB approval (and possibly new consent) first. Doing the work without it would breach respect for persons, regardless of how harmless it seems.

## Quick recap

- History (Nuremberg, Tuskegee, HeLa) explains why research protections exist.
- Belmont principles: respect for persons, beneficence, justice.
- IRBs review human research before it starts; consent is an informed, voluntary, ongoing process.
- IACUCs review animal research using the 3Rs; fabrication, falsification and plagiarism are misconduct.
- Official sources: HHS Office for Human Research Protections ([hhs.gov/ohrp](https://www.hhs.gov/ohrp)) and NIH Office of Laboratory Animal Welfare ([olaw.nih.gov](https://olaw.nih.gov)). Checked on 2026-10-23.


Explain how IRBs, informed consent and animal welfare committees protect people and animals in research.

Research ethics and consent

How IRBs Protect Human Research Participants

What is informed consent?

## Why it matters

Every decision a lab supports (a patient's diagnosis, the release of a vaccine batch, a published discovery) is only as good as the records behind it. Regulators found that many serious problems were not bad science but bad records: missing data, backdated entries, results re-run until they passed. **Data integrity** means data are complete, consistent and accurate throughout their life. The **ALCOA+** principles are the shared checklist regulated labs use, and they are good practice in any lab.

## ALCOA

The original five, popularised at the US FDA:

- **Attributable:** you can tell who recorded the data and who did the work, and when. Initials or signatures on paper; unique user logins (never shared passwords) on instruments and software.
- **Legible:** readable and permanent for as long as the record must be kept. Ink, not pencil; no erasing; electronic files in formats that can still be opened.
- **Contemporaneous:** recorded at the time the work was done, not later from memory or scrap paper.
- **Original:** the first record (or a verified "true copy"). The printout from the balance, the raw instrument file, the notebook entry. Transcribed numbers are not the original.
- **Accurate:** correct, with no errors or editing that is not documented. Changes are recorded with who, when and why, leaving the original visible.

## The "+"

Later guidance added four more:

- **Complete:** all data, including repeats, failed runs and re-tests, are kept. Nothing is deleted or left out.
- **Consistent:** entries follow the expected sequence, with dates and times in order and the same units and formats.
- **Enduring:** records last for the required retention period (bound notebooks, backed-up systems).
- **Available:** records can be found and read when needed, for review, audit or inspection.

Some organisations use **ALCOA++**, adding traceability, but the core idea is the same.

## Electronic records

Most lab data now live in instruments, LIMS and electronic notebooks. In the US, FDA rules on electronic records and signatures (**21 CFR Part 11**) apply to many regulated systems. Integrity features include unique logins, **audit trails** that log every create, change and delete with who, when and why, and controlled backups. A common inspection finding is a shared "lab" login, which makes every result non-attributable.

## A worked example: audit a record

Here is a QC record for a pH check of a buffer:

```text
Buffer lot B-0912   pH spec 7.30-7.50
Result: 7.41        Checked by: Lab        Date: (blank)
Note on sticky note attached: "1st reading 7.62 - recalibrated, re-ran"
```

Check it against ALCOA+:

| Principle | Problem |
|---|---|
| Attributable | "Lab" is not a person. Who measured it? |
| Contemporaneous / Consistent | No date or time, so you cannot place it in sequence. |
| Original | The first reading lives on a loose sticky note, not in the record. |
| Complete | The out-of-spec reading (7.62) is not part of the official record. |
| Accurate | Was the meter calibrated before the first reading? No record. |

A compliant version:

```text
2026-10-23 09:12  Buffer lot B-0912, spec pH 7.30-7.50.
pH meter #2, calibration check 09:05 with pH 7.00/10.00 buffers: FAILED slope.
Recalibrated 09:08 (pass, slope 98.7%).  Reading 1 (before recal) 7.62 - invalid,
  meter failed calibration check; deviation DEV-0331 opened.
Reading 2 09:12: 7.41  (PASS)                         -- A. Patel (AP)
Reviewed 2026-10-23 11:30 -- R. Gomez (RG)
```

Every value is kept, every action is attributable and dated, and the reason the first reading was invalid is documented and linked to a deviation. In a GMP lab, simply re-testing until a result passes ("testing into compliance") without an investigation is a serious violation.

## Common mistakes

- **Shared logins** or signing for someone else.
- **Writing on scrap paper** and copying later.
- **Deleting or not recording failed runs.**
- **Backdating** an entry to "fill a gap". Late entries must be marked as late, with the actual date written.
- **Unreviewed changes** to electronic data with the audit trail turned off.

## Quick recap

- ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate.
- Plus: Complete, Consistent, Enduring, Available.
- Keep every result, including failures; document every change with who, when and why.
- Electronic systems need unique logins and audit trails (21 CFR Part 11 in many US regulated labs).
- FDA guidance on data integrity is at [fda.gov](https://www.fda.gov); read the current version there. Checked on 2026-10-23.


Apply the ALCOA+ principles to judge whether a lab record is trustworthy, and fix one that is not.

Data integrity (ALCOA+)

ALCOA+ - An easy abbreviation for data integrity

ALCOA and ALCOA+ in Pharmaceuticals | Principles of ALCOA | Data Integrity Principles

GLP, GMP and CLIA, research ethics and consent, and ALCOA+ data integrity.

Foundations for Life Science & Biotech Careers

About this course

Course content

How Life Science Works

Getting Into the Lab

Regulation and Ethics

Where this course leads

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Careers that use it