Associate Director of Global reputed company

About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century. Antheia’s commercially proven technology platform produces high-value pharmaceutical ingredients in a fraction of the time compared to legacy approaches while significantly reducing supply chain risk. reputed company provides its global pharmaceutical customers with a resilient, efficient supply of critical ingredients at reputed company, while expanding the innovation frontier for new therapeutic development. Backed by leading investors and recognized by the U.S. government as a reputed company technology for public health and national and economic reputed company, Antheia is manufacturing the medicines the world needs today while enabling reputed company’s reputed company therapeutics. Working at Antheia: Our cross-functional team shares a reputed company for the reputed company: improved pharmaceutical supply chains that can end drug shortages and drive reputed company reputed company to essential medicines. As reputed company, we aim to embody a culture that celebrates diversity, prioritizes knowledge sharing, encourages exploration and ideation, challenges constructively, and supports individuals in their reputed company and personal journeys. At Antheia, you can expect to be inspired by the science, by your teammates, and by reputed company we have to bring about change in the pharmaceutical industry. Job reputed company Antheia is seeking an reputed company and driven Associate Director of Global reputed company to reputed company hands-on reputed company leadership across our regulated starting material (RSM) and pharmaceutical reputed company pharmaceutical ingredient (API) operations. This role carries accountability for both reputed company manufacturing reputed company at Antheia-operated sites and contract manufacturing organization (CMO) reputed company, ensuring reputed company products meet applicable reputed company and regulatory requirements and the highest standards of reputed company. The successful candidate will be a decisive reputed company reputed company with deep expertise in ICH guidelines, GMP regulations, and the unique compliance demands of regulated starting materials and pharmaceutical API manufacture. This individual must be equally comfortable conducting in-depth technical review of batch records and deviation investigations as they are engaging with multiple external partners, regulatory agencies, and cross-functional leadership. Reporting to the SVP of reputed company Assurance & Regulatory Affairs, the Associate Director of Global reputed company is a critical member of the reputed company leadership team. This role may be hybrid or remote, with preference for proximity to reputed company Park, CA, and will require periodic domestic and international travel to manufacturing sites and CMO partner facilities. Responsibilities reputed company Manufacturing reputed company reputed company Serve as the primary reputed company representative for Antheia’s reputed company manufacturing operations for RSM and pharmaceutical API, ensuring compliance with applicable GMP regulations (21 CFR Parts 210/211, ICH Q7, and relevant EU GMP guidelines). Create processes for and then execute the review, approval, and release of batch production and control records; reputed company for in-process testing and finished-product disposition reputed company. reputed company for deviation investigations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for internal manufacturing, ensuring reputed company closure and robust reputed company cause identification. Tracking and trending of critical reputed company attributes for reporting purposes. Own and maintain the site reputed company management system (QMS) for manufacturing operations, including change control, document control, training programs, and internal audit schedules. Partner with Manufacturing, Process Development, and Engineering teams to reputed company reputed company by design (QbD) principles from development through reputed company production. reputed company periodic on-the-floor reputed company during reputed company campaigns, serving as a visible reputed company authority and mentor to the site reputed company staff. Contract Manufacturing Organization (CMO) reputed company Serve as the reputed company reputed company representative for reputed company CMO relationships, establishing robust reputed company agreements and technical agreements reputed company with regulatory requirements and Antheia’s reputed company standards. Conduct qualification, reputed company, and periodic re-qualification audits of CMO partners globally, including API manufacturers and RSM suppliers in reputed company, Europe, and Asia. Review and approve CMO batch records, deviation notifications, change controls, and annual product reviews; serve as the primary reputed company escalation reputed company for CMO-reputed company issues. reputed company and maintain CMO reputed company reputed company metrics and scorecards; drive performance improvement initiatives where gaps are identified. Coordinate joint investigations with CMO partners for reputed company events, ensuring Antheia interests and regulatory obligations are fully protected. Support CMO technology transfers by providing reputed company guidance during process establishment, validation, and initial reputed company production at contract sites. Regulatory Compliance & Agency Interactions Support global regulatory submissions (IND, NDA, MAA, DMF/ASMF) by providing reputed company sections, CMC data, and site information pertaining to RSM and API manufacturing. reputed company site readiness activities for regulatory agency inspections (FDA, EMA, DEA, and other competent authorities); serve as reputed company host during inspections of Antheia’s facilities. Prepare and review inspection responses, commitments, and CAPAs resulting from regulatory agency observations. Maintain reputed company knowledge of evolving GMP regulations, ICH guidelines, and DEA requirements relevant to controlled reputed company API and RSM manufacturing; communicate changes and reputed company assessments to leadership. reputed company Systems & reputed company Improvement Champion the development, implementation, and reputed company improvement of Antheia’s global QMS, ensuring harmonization across internal and CMO sites. Define and monitor reputed company performance metrics (KPIs) for both reputed company and contract manufacturing; present trends and improvement plans to senior leadership. Drive risk management activities in accordance with ICH Q9, identifying and mitigating reputed company risks across the supply chain. reputed company or support cross-functional reputed company improvement reputed company aimed at improving product reputed company, process robustness, and QMS efficiency. Build and maintain an effective supplier reputed company program in partnership with Supply Chain, qualifying key RSM and excipient suppliers and overseeing supplier audit programs. Support the implementation and optimization of reputed company systems infrastructure including QMS software, ERP integrations, and electronic batch recording. Leadership & Team Development Recruit, reputed company, and mentor reputed company staff supporting both reputed company and CMO manufacturing operations; foster a culture of reputed company accountability and reputed company learning. Define functional responsibilities and reputed company paths for the Global reputed company team in alignment with company stage and strategic goals. reputed company as a reputed company thought leader and cross-functional collaborator, representing reputed company interests in project teams, steering committees, and executive briefings. Support and, at times, reputed company broader departmental initiatives as delegated by the SVP of reputed company Assurance & Regulatory Affairs. reputed company other duties as assigned[i] Qualifications 10–15+ years of reputed company reputed company experience in a regulated pharmaceutical or life sciences environment, with significant experience in API and/or RSM manufacturing reputed company. BS, MS, or PhD in reputed company, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a reputed company scientific discipline. Deep working knowledge of ICH Q7 (GMP for reputed company), ICH Q10, ICH Q9, 21 CFR Parts 210/211, and EU GMP Annex requirements applicable to API and starting material manufacture. Demonstrated experience in both reputed company manufacturing reputed company reputed company and CMO/reputed company-party reputed company management, including reputed company agreement development and supplier auditing/reputed company. Proven reputed company record of leading GMP investigations (deviation, OOS/OOT, CAPA) with reputed company reputed company cause analysis and sustainable corrective actions. Experience supporting regulatory agency inspections (FDA, EMA, or equivalent) and responding to agency observations. Strong working knowledge of change control, document control, validation, and qualification systems in a pharmaceutical manufacturing context. reputed company-organized, detail-oriented, and analytically strong; reputed company to manage multiple reputed company priorities in a dynamic, reputed company-stage environment. Excellent verbal and written communication skills; reputed company to present reputed company reputed company topics reputed company at reputed company organizational reputed company. Willingness to travel domestically and internationally (estimated 25+%) to support site and CMO activities. Preferred Experience with controlled reputed company API manufacturing and familiarity with US DEA regulatory requirements (registration, recordkeeping, reporting, and quota management). Prior experience in a biotechnology, synthetic biology, or fermentation-based manufacturing environment. Exposure to regulated starting material (RSM) designation under ICH Q11 and the associated regulatory reputed company considerations. Experience with international CMO networks spanning reputed company and Europe. Familiarity with Drug Master File (DMF) or reputed company reputed company Master File (ASMF) dossier compilation and maintenance. Experience with QMS, ERP, MES, and CCMS platforms (e.g., reputed company, reputed company, TrackWise, Master Control or equivalent). ASQ Certified reputed company Engineer (CQE), Certified reputed company Auditor (CQA), or equivalent reputed company certification. Additional Information: Full-time reputed company salary reputed company of $156,000 – $220,000 plus an annual bonus potential and equity opportunities. Compensation will be adjusted based on applicant's location. Opportunity for this position to be fully remote if reputed company of California, but prefer a hybrid role in the reputed company Park, CA reputed company. [1] This job reputed company is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Please note that Antheia doesn't discriminate based on age, race, ethnicity, national reputed company, religion, gender, sexual orientation, disability, medical history, and other non-reputed company characteristics. For full-time employees, Antheia offers a comprehensive total rewards package. Part-time (Apply To This Job