Associate Director, Quality Control

Job not on LinkedIn

🕒 June 30

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $150k - $169k / year

⏰ Full Time

🟠 Senior

👔 Director

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Praxis Precision Medicines, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Praxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company translating insights from human genetics into the development of precision therapies for central nervous system (CNS) disorders, with a strong focus on genetic epilepsies and neuronal excitation–inhibition imbalance. The company uses genetics-driven target selection, translational tools, patient-guided development, and efficient clinical strategies to advance multiple clinical- and early-stage programs aimed at delivering high-impact treatments for patients with complex brain disorders.

📋 Description

• 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, with 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)