Associate Director, Quality Control

• 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

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 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)

To round out this world-class total rewards package, we provide base salary compensation in the range of $150,000 to $169,000 annualized .

Final salary range may be modified commensurate with job level, education, and experience.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.

At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.

Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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