QC Senior Scientist

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.

Learn more about Careers at Organogenesis

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.

Job Requirements

What You Need to Achieve It:

• 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.

• 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.

What sets us apart?

• Competitive Pay

• 401K - vested immediately with 100% match

• Education Assistance Policy - $5,000 per year for all employees

• Medical, Dental and Vision

• Flexible Spending Account or Health Savings Account

• Wellness Program

• Three weeks of vacation, 4 floating holidays, sick days, and company holidays

• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, or any other characteristic protected by law.

Physical Required

Job Type

Full-time

Location

Organogenesis Inc. Corporate Headquarters - Canton, MA 02021 US (Primary)

Education

Master's Degree

Career Level

Individual Contributor

Travel

0 - 10%

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