QC Director | Quality Control @ STC Biologics, Newton, Massachusetts: STC Biologics, Inc. is a boutique Biologics product development services company in Newton, MA that enables Speed to Clinic through a highly flexible and dynamic organization in close partnership with clients, and with its track record in global approval of products. Our current capabilities (cell line development, process development, analytical development and biophysical/biochemical characterization, formulation development, as well as cGMP release and stability programs) will be enhanced in 2018 with establishing GMP production ability to provide integrated CMC solutions both locally in MA and to our current and expanding global clients.
We are seeking a Biologics technical and GMP compliance leader to head up the Quality Control function and drive client programs with efficiency and high quality. As a member of the management team, the candidate has the opportunity to contribute to the growth of our organization and approval of exciting novel therapeutics.
- Oversight of all aspects of Quality Control, including
- ensuring laboratory compliance
- managing the cGMP release and stability testing
- managing assay qualification, transfer, validation
- managing development stability programs
- managing manufacturing testing support once established.
- Project management of GMP projects and communicating status/data to clients.
- Write/review/approve quality documents, including test procedures, protocols, reports, deviations/investigations, qualification of instrument and personnel.
- Host external audits in collaboration with QA.
- Close communication with senior management on project plans, resources, monthly invoicing.
- Maintain current knowledge of industry trends, standards, and methodologies as it relates to cGMP and Quality Control activities.
- PhD in analytical/protein chemistry or related disciplines with at least 5 years of Quality Control experience in a regulated Pharmaceutical or Biotechnology industry.
- Demonstrated success in managing people
- Superb written and oral communication skills with all levels of the organization.
- Flexibility and effectiveness in teams and oversight of non-reporting personnel to meet goals efficiently and timely
- Drive and energy to thrive in a fast-paced environment
- Knowledge of ICH and regulatory guidelines, cGMP requirements. Experience with setting specifications and writing for regulatory submissions.
- Technical skills in protein HPLC and capillary electrophoretic methods, qPCR, immunoassays, bioassays, and compendial tests for parenteral products.
Location: Newton, Massachusetts, 02460, United States
Job ID: 39114463
Posted: January 24, 2018
Position Title: QC Director
Company Name: STC Biologics
Job Function: QA/QC
Job Type: Full-Time
Job Duration: Indefinite
Min Education: Ph.D.
Min Experience: 5-7 Years
Required Travel: 0-10%
How to apply:
- Please email your resume and cover letter to [email protected]