Associate Director, Quality Control (56861)

Associate Director Quality Control

Reports to: Senior Director Quality Operations CMC
Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

Praxis is seeking a highly experienced motivated and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director Quality Control to support QC product release and stability activities. Reporting to Senior Director Quality Operations CMC this position will be responsible for managing and executing Quality Control activities in support of product testing release and stability and toxicology studies test material inventory support. Ensure GMP activities are conducted in accordance with applicable SOPs compendia approved methods and in accordance with companys and regulatory agencies policies and procedures.

Primary Responsibilities

• 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 SOPs 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

Qualifications and Key Success Factors

• 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

Compensation & Benefits

At Praxis were 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 employees 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 $150000 to $169000 annualized. Final salary range may be modified commensurate with job level education and experience.

Company Overview

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.

Diversity Equity & Inclusion

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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