Senior QC Scientist, Chemistry

Canton, MA

Job Req code: 967

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 by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.

The Senior QC Scientist, Chemistry position reports to the Manager/Sr. Manger, QC Chemistry partnering with others within and outside Quality Control as a senior team member and Subject Matter Expert of the Quality Control department to support routine and non-routine testing of materials and final product involving complex analytical assays and bioassays.  Another significant aspect of this position extends to being a lead contributor in method and technology transfers, qualifications/validations, microscopy, and deviation support and investigations ensuring the highest standards of quality and compliance are sustained.  This position requires the ability to perform high-level laboratory work and method development in various scientific/technical disciplines and excellent writing skills for authoring CMC sections and PMA supplements to support Medical Device, Biologics, and Cell Therapy regulatory filings.  

Key Responsibilities

  • Support routine CGMP testing coordinating and collaborating with other functional areas of Quality Control, Quality Assurance, Manufacturing, and Project Management across multiple facilities and locations including CMO’s.
  • Routine/non-routine testing of materials and product requiring expertise in various laboratory techniques and complex sample preparation and procedures involved in performing HPLC, ELISA, FTIR, MS, DSC, Nulceic Acid quantification, Cell-Based Potency, Flow Cytometry, SDS PAGE, Bioassays, and PCR as well as current USP methods and monographs.
  • Conduct investigational studies using microscopic techniques such as SEM, RAMAN, and more conventional inverted stage and stereo microscopy in conjunction with analytical methods for identification of unknown materials.
  • Support pre-clinical and animal grafting oversight at contract testing lab to conform with CGMP requirements.
  • Represent Quality Control on cross-functional Project Teams and provide technical/scientific guidance and strategies.
  • Perform troubleshooting for investigations under relevant Quality systems to identify root cause of failures and appropriate corrective/preventive actions relating to OOS’s, OOTr’s, deviations, and CAPA’s.
  • Support life cycle management of instrumentation, software, and validated state of assays.
  • Ensure data integrity of all raw data generated during the course of performing CGMP testing.
  • Apply appropriate statistical tools and methods for trending of data and establishing or reevaluating acceptance specifications used in the release of materials and product.
  • Develop/enhance/transfer and validate new and existing analytical methods and bioassays including authoring of validation/transfer protocols and reports.
  • Peer review and/or approval of test results to verify completeness and accuracy of reported test and trend data.
  • Actively and effectively apply critical thinking skills to anticipate and plan ahead of time to circumvent issues and to resolve complex problems as they arise.
  • Adhere to CGMP documentation practices, identify deficiencies in current SOPs and revise as necessary, and author new procedures.
  • Train and mentor other team members.
  • Maintain laboratory in a continued state of compliance and operation by adhering to established general housekeeping procedures and restocking/requalifying critical reagents, chemicals, and supplies.  

Requirements

Preferred Education and Experience

  • Minimum of a M.S./Ph.D. in Analytical Chemistry, Biochemistry, Protein Chemistry, or other related field with 8+ years of direct CGMP experience within the biotechnology, medical device, biopharmaceutical, or other similarly regulated industry.

Other Skills/Abilities

  • In depth expertise and hands-on performance of complex analytical and cell-based (bio)assays as well as associated method development, validation, and transfer are core requirements of this position. 
  • Experience authoring sections of regulatory submissions in support of PMA supplements, 510K, or BLA CMC would highly desirable.
  • A working knowledge of flow cytometry would be a plus. < 5% domestic and/or international travel is expected.

Physical Demands

  • The ability to lift and move items weighing as much as 30-40 lbs. may be necessary in the course of daily lab operations.
  • Visual acuity testing is administered to all new hires within QC and retesting is performed annually 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.