Senior Specialist, Client QA

The Sr. 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.  Client QA 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. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.

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.

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)

The candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 2+ years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 4+ years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Knowledge within 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.
• Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
• Creative individual with excellent analytical, trouble shooting, and decision-making skills

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus target. The final salary 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.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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