Associate Director, Quality Control (56861)

Job DetailsJob Location Remote - Boston, MARemote Type Fully RemotePosition Type Full TimeEducation Level 4 Year DegreeTravel Percentage Minimum of 2x/year to Boston areaJob Category BiotechAssociate Director, Quality ControlReports to: Senior Director, Quality Operations, CMCLocation: This position may be performed remotely with travel to the Boston area as needed. Position SummaryPraxis 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 company’s and regulatory agencies’ policies and procedures.Primary ResponsibilitiesQuality 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 requiredManage and lead clinical and commercial quality control compliance for stability, reference standard, and specification programsSupport 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 reportsPerform 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 applicableSupport technology transfer and process performance qualification with product characterization/process validation activitiesQC 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 projectsSupport tox material inventory monitoring process, to ensure no impediments to completing studiesAdditional responsibilities and ad hoc projects as requiredQualifications and Key Success FactorsBachelors degree strongly preferred, with minimum of 6 years of experience in cGMP Quality Control environmentIn-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 commercializationExperience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferredExtensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.Proven track record of managing stability programs and COA processes for clinical and commercial productsExperience working in QC lab environment with hands-on experience in running, qualifying, and validating analytical methodsAbility to work effectively in a fast-paced, dynamic environmentExperience managing Contract Test Labs activitiesExperience with regulatory inspections and interactions with health authoritiesExcellent communication skills and ability to build key networks and business relationships across all levels of the businessCompensation & BenefitsAt 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 plansBonus program structured to pay on a quarterly basis401k 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 moreUnlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefitEligibility 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.Company OverviewPraxis 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 & InclusionGuided 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. Attention: Job Scam AlertPraxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected] does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.Originally posted on Himalayas

Apply Now