About Us

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. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.

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What You Will Achieve:

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.

How You Will Achieve It:

• 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.