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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

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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