Associate Director, Quality Control

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🕒 Junho 30

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $150.000 - $169.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Praxis Precision Medicines, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

Praxis Precision Medicines, Inc. é uma empresa biofarmacêutica em estágio clínico que traduz insights da genética humana no desenvolvimento de terapias de precisão para distúrbios do sistema nervoso central (SNC), com forte foco em epilepsias genéticas e desequilíbrio de excitação-inibição neuronal. A empresa utiliza seleção de alvos baseada em genética, ferramentas translacionais, desenvolvimento guiado por pacientes e estratégias clínicas eficientes para avançar múltiplos programas em estágio clínico e inicial, com o objetivo de oferecer tratamentos de alto impacto para pacientes com distúrbios cerebrais complexos.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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)