Senior QC Scientist, Chemistry

Senior QC Scientist, Chemistry Canton, MA

Job Req code: 967

Category: Quality Systems

Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. 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.

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.  

 

 

 

RequirementsPreferred 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 QC Scientist position entails routine lab work that requires the ability to stand, sit, or combination of both for extended periods of time in the performance of complex assays within the general laboratory space, biological safety cabinets, or fume hood.
• Many assays require excellent dexterity and fine motor skills, good eye-hand coordination, and some repetitive motion.
• 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.

Environmental Conditions

• The QC Scientist should be knowledgeable, and when uncertain solicit the guidance of Environmental Health and Safety beforehand, on selection of proper personal protective equipment that must be donned in the performance of laboratory activities and assays, such as lab coat, safety glasses, nitrile gloves, heat/cold insulating gloves, masks, etc. to adequately protect the safety of oneself and others at all times.
• Additionally, it is incumbent upon the QC Scientist to solicit the support of Environmental Health and Safety to ensure appropriate environmental controls are in place and utilized during the course of executing laboratory work (e.g., fume hood, BSC, etc.) to ensure adequate and appropriate containment and/or disposal of potentially noxious, toxic, flammable, biohazardous materials, byproducts, and/or fumes in order to protect the safety of oneself and others in compliance with current Company policies and applicable regulations.