New · posted Nov 13
Catalent · Biotechnology
Senior Scientist, QC Analytical
- Harmans, MD
- On-site
- Full-time
- Senior & Principal
The role
We have an opportunity for a Senior Scientist, QC Analytical to join our team. In this role, you will support analytical testing to ensure GMP manufacturing for clinical and commercial clients. You will apply your technical knowledge, regulatory understanding, and commitment to scientific excellence to deliver high-quality results. This position reports to the Sr. Manager, Quality and offers the chance to work in a dynamic, fast-paced environment.
Shift: Monday – Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite
- Perform and support a broad range of analytical and molecular biology assays, including ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, DNA/RNA extraction, and related quality control testing.
- Troubleshoot laboratory, testing, and instrumentation issues, escalate concerns as needed, and recommend solutions to support batch release, stability, and special testing programs.
- Serve as a subject matter expert for key analytical techniques, providing technical guidance to auditors, vendors, and cross-functional teams.
- Mentor, train, and develop laboratory staff while promoting technical excellence and adherence to quality standards.
- Lead and support continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational performance.
- Create, revise, and maintain technical documentation, including assay protocols, SOPs, summary reports, and other GMP-controlled records.
- Review laboratory work, approve data packages, and ensure accurate data interpretation and reporting in accordance with quality requirements.
- Manage and support change controls (CRs), CAPAs, deviations, OOS investigations, and issue resolution activities to ensure product quality and compliance.
- Monitor laboratory equipment performance, including maintenance, troubleshooting, alarm response, and coordination of corrective actions.
- Communicate quality-impacting issues to management and maintain flexibility to support unique production campaigns, including off-hours and weekend operations when required.
- Other duties as assigned
What you need
Minimum Requirements
- Bachelor’s degree in a Life Sciences discipline with 4–6 years of experience in a cGMP QC laboratory, or Master’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory
- Knowledge and expertise in QC analytical methods used for protein chemistry and molecular biology
- Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work with strong familiarity of GMP practices
- Experience in writing Standard Operating Procedures (SOPs)
- Broad experience with biochemistry and related documentation
- Proficient in applying basic scientific and regulatory principles to solve operational and quality tasks
- Experience with Microsoft Excel and Microsoft Word
- Strong attention to detail and organizational skills
- Ability to succeed in a team-oriented environment under dynamic conditions
- Ability to work a set shift with occasional overtime as required
Preferred Skills & Backgroundnice to have
- Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis
Pay and benefits
$104,998 – $119,995 a year
Employer provided$50.48 – $57.69 an hour · yearly at 2,080 hours (40 a week)
How this comparesThe anticipated hourly rate for this position in MD is $50.48 – $57.69 Plus Bonus. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Medical, dental, and vision benefits effective day one
Competitive paid time off
8 paid holidays
Tuition reimbursement
Annual bonus
Defined career path
Where you'll work
Harmans, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Harmans, MD
From the posting
About Catalent
About Site
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.
The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
Why You Should Join Catalent
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
Equal opportunity, accessibility and legal noticesCatalent's statements, word for word
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in Maryland6 roles publishing pay
Senior & Principal roles in the US50 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $104,998 | — | $119,995 |
| Maryland (middle half) | $107,375 | $111,250 | $112,500 |
| All US (middle half) | $89,250 | $97,500 | $111,875 |
This role: Catalent's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 265 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Catalent's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods12
- GMP and compliance7
- Collaboration and leadership6
- Documentation and SOPs4
- Quality systems and risk2
- Investigations and CAPA1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
Company hiring pulse
Catalent on Regulatory Jobs
- 38
- Open roles
- 38
- Distinct roles
- 8
- Locations
By discipline
- Quality37 97%
- Regulatory1 3%
By level
- Associate & Specialist17 45%
- Senior & Principal14 37%
- Manager5 13%
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Senior Scientist, QC Analytical at Catalent
Applications close November 30. $105K–$120K a year, employer provided.