QC Manager, Chemistry and Analytical Support Services

Canton, MA

Job Req code: 838

Category: Quality Systems

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others. Empowering Healing.

The Manager of QC Chemistry and Analytical Support requires a proven leadership record, responsible for day-to-day cGMP operations within the QC Chemistry and Analytical Support s Group. Key to this position is the ability to work collaboratively and effectively at all levels of the organization across all functional areas, such as Quality Control, Manufacturing, Process Development, Regulatory and Quality Assurance, bringing solution-driven ideas based on critical thinking and strong technical fundamentals.   

JOB RESPONSIBILITIES

  • Provides broad-based QC Chemistry and Method Validation/Transfer expertise related to analytical and biological assays such as HPLC, SDS-PAGE, MTT, PCR, DSC, ELISA, FTIR, nulceic acid quantification, and current USP methods and monographs as well as associated instrumentation.
  • Manages the day-to-day cGMP laboratory activities of QC analysts and scientists directed toward timely release testing of raw materials, intermediates, starting materials and collagen/ cell-based products.
  • Ensures the successful transfer of new methods to QC Chemistry and the validation/re-validation of existing methods and instrumentation are performed as required and in accordance with the Method Validation Program and applicable regulations.
  • Support FDA inspections, third party audits, and Regulatory submissions as they relate to QC Chemistry and Analytical Support.
  • Supporting new IND and BLA applications and drafting relevant sections of CMC submissions
  • Identification, vetting and management of external QC and analytical service laboratories and CRO’s

 

Requirements

  • Minimum of a BS degree in Analytical Chemistry, Biochemistry, Biology, or related scientific discipline.  MS or PhD in related discipline preferred and 8-10 years of GMP experience in the pharmaceutical or biotechnology industry.
  • At least 5 years of experience with increasing responsibilities in management of cGMP laboratory operations and method validation, with a minimum of 3 years supervisory/leadership experience required.
  • Excellent communication and writing skills is an essential requirement of this position.

TEST REQUIREMENTS

Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards.