Catalent Cell & Gene Therapy is looking to recruit a Specialist, Client QA to join our growing BWI team in Harmans, MD. The Specialist, Client QA is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The Client QA Contact serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit.

Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Role:

• Provides dedicated QA support to client projects and client interactions & meetings. Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product

• Involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.

• Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch)

• Works with clients during initial and subsequent manufacturing campaigns

• Conducts review of master batch records during Technical Transfer for client processes

• Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)

• Maintains databases and systems used for tracking various GMP manufacturing associated support activities

• Assists with the review and approval of GMP documentation such as Standard Operating Procedures

• Support regulatory (i.e. FDA, EMA) and client audits/inspections; Assists with internal audits of GMP systems and facilities

• Other duties as assigned

The Candidate:

• B.S., Life Sciences discipline

• 2+ years’ experience in Quality Assurance/Quality Control function or related function. A combination of experience acceptable.

• Experience within biologics, biopharmaceuticals, or regulated industry preferred

• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.

• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• 19 days of PTO + 8 paid holidays

• Employee Stock Purchase Program

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 DisabilityAccommodations@catalent.com. 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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.