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.
- 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 email@example.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.