ASSOCIATE DIRECTOR OF BIOLOGICS CONTROL

Our top-ten pharmaceutical client has achieved market leadership because of an unwavering commitment to the values of excellence, reliability, growth, innovation, fairness and good citizenship.

This company has one of the worlds most productive and respected research organizations. They are dedicated to discovering and developing innovative, cost-effective medicines that address significant unmet medical needs that extend and enhance human life. Their pipeline is filled with unique products, a key to future success.

The Associate Director of Biologics Quality Control will set the direction for biological quality for the entire organization. You will use your Quality Control Lab management experience and proven leadership skills to deliver a vision for this growing operation. As a key member of the QC/QA leadership team, you will develop strong partnerships with other departments, e.g., Analytical Development, Manufacturing, Purchasing, external contractors, etc. If you are eager to join a company that is preparing to launch dramatic new products, then we want to talk with you.

Primary Function:
· Manage, build and oversee the daily operation of a newly created and dynamic Biologics Quality Control Department.
· The group’s primary function will be the release and stability testing of commercial biologics drug substance and drug product. Management will consist of several functional areas, which include: cell and immuno-biochemistry, separation sciences, spectroscopy and physical analyses laboratories.

Primary Responsibilities:
· Training analytical scientists
· Developing GMP-compliant laboratory systems and procedures
· Technology transfer of methods
· Qualification and maintenance of laboratory equipment
· Preparation/review of out-of specification result reports
· Analysis of data for the presence of adverse trends
· Preparation of protocols and final reports for special studies
· Provide oversight of Facilities Planning, Design and Renovation initiatives associated with the department
· Participation in compliance related teams towards the goal of continuous improvement would also be needed

Required Skills, Experience and Keys To Success:

· Candidate should have an in-depth knowledge of analytical biochemistry Quality Control procedures, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, EP) to daily laboratory operations.
· Experience with the FDA including inspections and document preparation is necessary.
· Candidate must be proficient in the use of computers and software applications.
· Must have experience working with a variety of laboratory equipment, instrumentation, and techniques including, but not limited to HPLC, LC/MS, spectroscopy, cell culture, immuno assays, and data control/archive systems.
· Candidate must have dynamic leadership skills including the ability to communicate effectively both verbally and in writing
· The candidate will have an MS or PhD. in Biological Sciences with an emphasis on Protein Chemistry.
· A minimum of 8-10 years experience in supervision of a QC Biologics laboratory or in a related biopharmaceutical industry is required. To be considered please email us at staffing@pharmaceuticalrecruit.com