Scientist, QC Analytical

Catalent Pharma Solutions; Maryland; On-site; USD 53,000 - 66,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and holidays

Onsite well-equipped facilities

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking a Scientist, QC Analytical to support analytical testing for GMP manufacturing of clinical and commercial products. The role requires strong technical knowledge, familiarity with regulatory principles, and a commitment to scientific excellence.

100% onsite shift is Monday–Friday, 8am–5pm. The candidate will perform assays (ELISA, qPCR, HPLC, Capillary Electrophoresis) and document results per GMP/GDP.

Qualifications

• Bachelor’s degree in Life Sciences with 2+ years in a cGMP QC lab.
• Master’s degree in Life Sciences with 1+ year in a cGMP QC lab.
• Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work.
• Experience in writing standard operating procedures (SOPs).
• Strong biochemistry foundation; attention to detail and teamwork.

Responsibilities

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH.
• Document testing in compliance with GMP/GDP procedures.
• Generate internal and external documents such as assay protocols, summary reports, and SOPs.
• Provide analytical support to QC method services for method verification of platform test methods.
• Support release and stability testing for raw materials, components, standards, and finished products.
• Review laboratory work and approve data packages as designated by the Supervisor.
• Maintain and troubleshoot instrumentation, ensuring accurate data interpretation.
• Write laboratory investigations, out-of-specification reports, deviations, CAPAs, and perform statistics.
• Review paper and electronic records for accuracy and compliance.
• Report issues to management and participate in investigations.
• Work under general supervision to meet project goals and occasional overtime.
• Participate in training activities and manage training plans.

Skills

ELISA

qPCR

ddPCR

HPLC

Capillary Electrophoresis

GMP

Documentation

SOP writing

Excel

Word

Education

Bachelor’s degree in Life Sciences with 2+ years in a cGMP QC lab

Master’s degree in Life Sciences with 1+ year in a cGMP QC lab

Job description

Scientist, QC Analytical

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.

Position Summary

We have an opportunity for a Scientist, QC Analytical to join our team supporting analytical testing for GMP manufacturing of clinical and commercial products. This role requires strong technical knowledge, familiarity with scientific and regulatory principles, and a commitment to scientific excellence. The Scientist, QC Analytical will report to the Supervisor, QC Analytical and contribute to maintaining high-quality standards in testing and documentation.

Shift

Monday – Friday, 8am-5pm

Location

Harmans, MD - BWI 100% Onsite

The Role

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH.
• Document testing in compliance with GMP/GDP procedures.
• Generate internal and external documents such as assay protocols, summary reports, and standard operating procedures (SOPs).
• Provide analytical support to QC method services for method verification of platform test methods.
• Support release and stability testing for raw materials, components, standards, and finished products.
• Review laboratory work and approve data packages as designated by the Supervisor.
• Maintain and troubleshoot instrumentation, ensuring accurate data interpretation.
• Write laboratory investigations, out-of-specification reports, deviations, corrective and preventive actions (CAPAs), and perform statistical analysis and trending.
• Review paper and electronic records for accuracy and compliance.
• Report issues to management and participate in issue resolution and investigations.
• Work under general supervision to meet project goals and adapt to off‑hour or weekend work as needed.
• Participate actively in training activities and manage individual training plans.
• Perform other duties as assigned.

The Candidate Minimum Requirements

• Bachelor’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline with at least 1 year of experience in a cGMP QC laboratory.
• Experience in the biologic, pharmaceutical, or medical device industry performing hands‑on QC work with strong familiarity with GMP practices.
• Experience in writing standard operating procedures (SOPs).
• Strong foundation in biochemistry with hands‑on experience reviewing documentation and applying scientific and regulatory principles to support quality and operational activities.
• Demonstrates excellent attention to detail, organizational skills, and the ability to work effectively in fast‑paced, team‑oriented environments.
• Proficient in Microsoft Excel and Word, leveraging these tools to manage documentation, analyze data, and support business processes.
• Ability to work a set shift with occasional overtime as required.

Preferred Skills & Background

Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.

Pay

The anticipated hourly rate for this position in MD is $38.46 – $48.07 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs. Catalent is a multi‑state employer, and this salary range may not reflect positions that work in other states.

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.

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 [e-mail]. 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.

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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.