The Manager, of QC Chemistry and Analytical Support, requires a proven leadership record, responsible for day-to-day cGMP operations within the QC Chemistry and Analytical Support s Group. This individual coordinates staff in the timely scheduling, test execution, and reporting of all release testing, and manages change controls, method validation/transfer and stability programs in compliance with all applicable FDA regulations for Device, Biologics, and Combination Products as well as ICH Guidelines, USP and applicable national and international standards. Key to this position is the ability to work collaboratively and effectively at all levels of the organization across all functional areas, such as Quality Control, Manufacturing, Process Development, Regulatory and Quality Assurance, bringing solution-driven ideas based on critical thinking and strong technical fundamentals. The QC Manager must also be committed to mentoring staff members and providing opportunities for professional development and career advancement.
Provides broad-based QC Chemistry and Method Validation/Transfer expertise related to analytical and biological assays such as HPLC, SDS-PAGE, MTT, PCR, DSC, ELISA, FTIR, nulceic acid quantification, and current USP methods and monographs as well as associated instrumentation.
Manages the day-to-day cGMP laboratory activities of QC analysts and scientists directed toward timely release testing of raw materials, intermediates, starting materials and collagen/ cell-based products.
Evaluation of newly developed in-house methods or compendial methods for suitability and acceptability
Ensures the successful transfer of new methods to QC Chemistry and the validation/re-validation of existing methods and instrumentation are performed as required and in accordance with the Method Validation Program and applicable regulations.
Coordinates testing with external contract testing laboratories as well as required assay validation activities.
Perform routine technical reviews of internal and external release test data reports.
Maintains the Stability Program for materials and final products in accordance with applicable regulatory requirements and ICH guidelines.
Support the Operations group and project teams with respect to devising and/or executing stability, cleaning, sterilization, and process validation studies.
Prepare and conduct routine technical reviews of validation protocols and reports.
Lead and/or provide directional support to staff related to GMP laboratory investigations (e.g., OOS/OOTr, deviation, CAPA, and RCA).
Maintain laboratory operations and records in cGMP compliant state
Conduct periodic trending of laboratory test results and establish meaningful metrics for evaluating laboratory performance on an ongoing basis.
Identify and implement opportunities for Continuous Quality Improvement by monitoring evolving regulations and best practices.
Support FDA inspections, third party audits, and Regulatory submissions as they relate to QC Chemistry and Analytical Support.
Supporting new IND and BLA applications and drafting relevant sections of CMC submissions
Identification, vetting and management of external QC and analytical service laboratories and CRO's
Participate in the planning and management of functional goals and objectives including resource management, budgeting and capital expenditures.
PREFERRED EDUCATION AND EXPERIENCE
Minimum of a BS degree in Analytical Chemistry, Biochemistry, Biology, or related scientific discipline. MS or PhD in related discipline preferred and 8-10 years of GMP experience in the pharmaceutical or biotechnology industry.
At least 5 years of experience with increasing responsibilities in management of cGMP laboratory operations and method validation, with a minimum of 3 years supervisory/leadership experience required.
Excellent communication and writing skills is an essential requirement of this position.
Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing 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.
Organogenesis Inc. Corporate Headquarters - Canton, MA 02021 US (Primary)
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