Associate Director, QC Analytical Testing Operations

Proclinical is currently recruiting for an Associate Director of Analytical Testing Operations and Quality Control with a leading biotechnology company located in Gaithersburg, MD. As the Associate Director, you will lead the analytical testing program from clinical development through commercialization for product related samples.

Job Requirements:

• Leading a team of 20-30 persons including supervisors/managers and analysts
• Coaching, Mentoring, and developing staff
• Conducting performance reviews and ensuring establishment of SMART Goals
• Verifying staff training and competency and ensuring only trained and qualified staff perform test of record analyses.
• Managing proper staffing, training, and competency.
• Providing direct supervision to assigned staff
• Ensuring compliance with cGMP and safety requirements within QC
• Representing QC on cross functional teams
• Managing testing schedule by working with internal and external testing labs to meet release times in support of manufacturing operations.
• Authoring and maintaining standard operating procedures (SOP) as appropriate

Skills and Requirements:

• BA, BS or MS in Biology, Biochemistry, Pharmaceutical Science or related discipline plus 10-13+ years of related biopharmaceutical laboratory experience in a cGMP environment, with at least 8 years of management experience
• Experienced in writing and reviewing technical documents
• Possess excellent organizational, time management and multi-tasking skills to meet commitments and deadlines
• Possess excellent customer service skills and have strong verbal and written communication skills
• Ability to work in dynamic fast paced team environment
• Scientific background in analytical methods needed for raw materials
• Experience in writing SOPs, investigations, stability protocols and reports as well as annual product performance reports.
• Experience interfacing with CMOs/CTLs
• Demonstrates strong attention to detail
• Demonstrates Effective Problem Solving
• Ability to work independently and carry out tasks with limited instruction
• Ability to work in a dynamic and fast paced team environment
• In depth understanding of FDA, EMA, ICH guidelines and regulations associated with the quality control of biological products
• Knowledge of and experience with deploying Lean Methodology in laboratory environments
• In depth knowledge of compendial requirements for testing (USP, EP, JP).
• Experience with QMAS (Quality Management and Analysis System) and JMP

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or j.lawrence@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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