Manager, Quality Control
ImmunoGen, Inc. is seeking a Manager, of Quality Control to manage the chemistry and raw materials groups out of our Norwood facility. The successful candidate will continuously improve on quality control systems and provide support to manufacturing and facilities, while working in compliance with ImmunoGen’s quality policies and cGMP requirements. This candidate will also contribute to the overall achievement of department and corporate goals.
Job responsibilities include but not limited to the following:
- Manage QC raw material staff: Provide guidance, career development to direct reports
- Develop individual goals
- Provide support to budget development and monitoring for areas of responsibility
- Ensure appropriate identification, selection and oversight of contract test labs
- Develop analyses for in house testing versus outsourced testing
- Collaborate with analytical development groups, partners, CMOs & CTLs, as necessary
- Ensure appropriate completion and review of routine QC documentation
- Perform routine audits of Quality Control Systems as part of continuous improvement and preventive action
- Lead investigations of Out-of-specification results
- Monitors invalid-assay rate and identifies root cause and corrective action as, necessary
- Maintains centralize testing schedule
- Serve as the QC technical expert as it pertains to in-process, release and stability testing
- Assist in writing / review of regulatory documents, reports
- Works with QA unit and Inventory Control staff to support timely disposition of raw materials and intermediates
BS degree in biochemistry or in a related scientific field. Minimum of 8 years experience in pharmaceutical/biopharmaceutical quality control with at least 3 years in a supervisory role, or a minimum of 8 years experience in a testing laboratory with 5 years in a GMP environment and at least 3 years in a supervisory role. Experience applying phase appropriate (Phase I- III) QC policies and practice. Candidate must have the ability to work well in a cross-functional environment.
Candidate may be required to lift 30 lbs., working with hazardous chemicals up to Safe Bridge Level III. Also, candidate may be required on occasions to work extended hours and weekends. Some travel is required.
ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance. Please send a detailed resume to: Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: 781-895-0611; E-mail: firstname.lastname@example.org. Please reference the ad source in your response.
We are an Equal Opportunity Employer