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Senior Project Manager, CMC (Chemistry, Manufacturing Controls) (Full Time)

Location: Austin, TX Country: United States of America
 

Senior Project Manager, CMC (Chemistry, Manufacturing & Controls)

MTEM requires a highly capable CMC Project Manager to drive successful execution of critical internal and external/alliance partner programs for manufacturing and commercialization of complex biologics such as recombinant protein Engineered Toxin Bodies (ETBs). The ideal candidate for this position must be highly proficient in both technical CMC process and Project Management skills while operating in a fast-paced dynamic environment. Responsible for applying advanced principles of molecular biology, protein expression and purification, E.coli based fermentation and FDA Quality and Regulatory compliance requirements to provide comprehensive and highly effective CMC project management leadership. Programs will require application of effective project management principles and precise timeline tracking across a span of areas and deliverables including, analytical Methods, Process Development, Non-GMP and GMP manufacture, IND submission, clinical studies and NDA licensure. Duties include: Manage all aspects of alliance collaborations with Partner Pharmaceutical companies including timelines, non-GMP and GMP manufacture, clinical studies, regulatory filings, risk management and strategic planning. Define, develop and execute FDA/international Reg compliant CMC project plans for Drug Substance (DS) and Drug Product (DP) manufacturing and commercialization. Define complete project scope including activities, timelines, deliverables, risk management plan, communication plan, and budgetary plans, for all assigned MTEM projects. This includes working with stakeholders to define an approvable product specification, batch record reviews, analytical method reviews, generation of stability plans and reports, product investigation and CAPA summaries. Drive all aspects of outsourced contracting including vendor identification, evaluation (delivery capabilities, cost, budget and timing), RFP development, proposal evaluation, contract negotiation, contract execution, PR/PO generation, invoice review, deliverables acceptance and contract close-out.

This requires technical acumen in the following areas: Analytic/bio-analytic method development, qualification, validation, and tech transfer for drug potency, purity, ID, and any potential impurities (residual solvents, endotoxins, etc.). Cell bank (RCB, MCB, WCB development and qualification) Upstream, midstream and downstream manufacture Drug product filling capabilities (aligned with clinical program needs) Instrumentation capabilities (SE-HPLC, column packing, qualification and CIP, UF/DF, CGE, potency, GC, flow cytometry, ELISA and other molecular biological assays and systems). Provide project management leadership by integrating all aspects of Quality (QA/QC), Regulatory, GMP manufacturing readiness, facility compliance, process and operational controls etc. into project governance. Possess excellent problem-solving skills from a project managerial, operational, technical, financial, quality/regulatory perspective. Provide highly effective project management using PM tools such as Smartsheets, MS Project, 10,000 feet, MS Office Suite and Office365 (Word, Excel. PowerPoint, SharePoint, etc.) to maintain and communicate project information. Manage projects with efficient governance including schedule and budget variance management, project dashboard/weekly updates to upper management, managing technical project meeting agendas, discussions and action items, FDA/EU regulatory Agency interactions and filings, etc. all in alignment with ongoing CMC development-manufacturing efforts (per FDA 21 CFR) and corporate drug development efforts and priorities. Draft, review, approve and manage project related contracts, reports, change orders, financial dispositions and conflicts with CMOs/CROs. Provide precise tracking of deliverables, contract timelines and milestones, PO status, budget impact and forecast updates. Exercise detailed understanding of test requirements as per USP (or EP, JP, BP etc. when applicable) enabling technical and quality management system adherence to internal SOPs, as well as when specifically required, such as for product investigations, OOS/CAPA review and coordination, understanding and implementing ICH-FDA guidelines.

Minimum requirements: Master's degree in Biochemistry, Molecular Biology or related field plus 6 years of combined experience with manufacturing, clinical development and project management.

Experience must include: 4 years of experience with CMC efforts related to GMP (21 CFR good manufacturing practice); 4 years of experience with GMP/GCP US and EU regulations; 5 years of experience evaluating/selecting vendors and managing contract relationships, particularly CMO and CRO management; 3 years of experience in 21 CFR quality and regulatory guidelines, 5 years of experience designing and managing projects independently; 5 years of experience leading cross-functional project teams; 2 years of experience with hands-on protein expression and purification, biochemistry, molecular biology projects.


Posted Date: 12 Nov 2019 Reference: JS064729AUSTINTX Company: Molecular Templates, Inc Contact: Molecular Templates, Inc