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Hybrid Associate Director, Quality Control
Posted 3 weeks ago
About the role
- Quality control oversight of contract lab activities e.g. routine testing, testing results review and approval, generation of Certificate of Analysis, review/approval of technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs as required
- Manage and lead clinical and commercial quality control compliance for stability, reference standard, and specification programs
- Support the establishment of QC systems such as product specifications, product expiry, reference standard program, QC documentation including SOP’s, material specifications and other quality documents, etc.
- Support CMC Analytical Development in a QC aspect by review and approval of applicable documents in support of activities such as method development, transfer, characterization, comparability investigations, analytical test method qualification plans/protocols and reports
- Perform data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents, as applicable
- Support technology transfer and process performance qualification with product characterization/process validation activities
- QC support in the generation, quality, and compliance review of bioanalytical data from preclinical and clinical projects for proprietary compounds and in some cases support for sample analysis projects
- Support tox material inventory monitoring process, to ensure no impediments to completing studies
- Additional responsibilities and ad hoc projects as required
Requirements
- Bachelors degree strongly preferred
- Minimum of 6 years of experience in cGMP Quality Control environment
- In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in all phases of product development and commercialization
- Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred
- Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements
- Proven track record of managing stability programs and COA processes for clinical and commercial products
- Experience working in QC lab environment with hands-on experience in running, qualifying, and validating analytical methods
- Ability to work effectively in a fast-paced, dynamic environment
- Experience managing Contract Test Labs activities
- Experience with regulatory inspections and interactions with health authorities
- Excellent communication skills and ability to build key networks and business relationships across all levels of the business.
Benefits
- 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
- Bonus program structured to pay on a quarterly basis
- 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
- Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
- Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
- Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
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