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Associate Director, Commercial Stability

Company: Ascent Services Group
Location: San Mateo
Posted on: May 3, 2021

Job Description:

Associate Director, Commercial StabilityAssociate Director, Commercial StabilitySan Mateo, CASummaryThe successful candidate is responsible for leading a commercial stability team that would oversee global stability programs for the Company at CMOs and contract testing laboratories. The candidate will be responsible for contributing to key functional, tactical, and operational aspects of the commercial stability group. Knowledge of cGMP and filing regulations, guidelines, industry practices, and trends pertaining to the manufacture and stability testing of biologics is a requirement. The candidate must have excellent written and verbal communication skills.ResponsibilitiesThis individual will provide technical expertise and execute stability program activities of commercial biologic and pharmaceutical productsActivities include protocol authoring, LIMS study approval, stability data evaluation and trending, expiry dating of products and authoring stability reportsCritically review stability documents for consistency and qualityWork in collaboration with regulatory sciences, CMC teams and technical experts to author CMC stability sections of initial and post approval HA submissionsRespond to HA stability questionsComplete and close all stability studiesAuthor APQR and present the data at internal meetingsAct, escalate, identify information regarding stability programs that may impact product studies or regulatory commitments directly and promptly to line managementApprove, identify, write and revise stability related SOPsServes as resource for deviations, investigations, OOT/OOS, and CAPAs for stability related quality eventsCapture, measure, and report critical performance and compliance metrics related to stability testing, review and approval cycle times and investigationsRequirementsPrior experience with stability programs and demonstrated expertise in Biologics, Pharmaceutical or Protein Therapeutic moleculesKnowledge and understanding of ICH Guidelines (Q1A, Q5C), US/EU/ROW stability requirements, and industry best practicesThorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics or pharmaceutical manufacturing facilityAble to prioritize objectives from multiple projects, and deliver according to overall strategyHands-on experience authoring stability sections for submissions, technical assessment of stability specification changes, and stability investigationsDemonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environmentStrong leadership and decision-making skillsExperience with evaluating and interpreting stability data using statistics and statistics softwareData entry and verification experience in the electronic laboratory information management system (LIMS)Strong computer, scientific and organizational skillsPhD plus 5 years industry; MS/BS and 10+ of related industry experienceJob Type: Direct PlacementLocation: San Mateo, CAJob ID: 21-03528Date Updated: April 13, 2021Summer Martinez is recruiting for this position.Corporate Office1001 Galaxy Way, Suite 405Concord, CA 94520925-627-4900info@Employment VerificationsVia The Work Number, employer code 105779Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.SDL2017

Keywords: Ascent Services Group, San Mateo , Associate Director, Commercial Stability, Other , San Mateo, California

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