Associate Director, Drug Product MS&T

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Responsibilities

• Lead onboarding and technical oversight of Drug Product CMOs (OSD) and provide technical input to MSAs, SoWs, and KPIs.
• Own dual sourcing technical enablement: lead the technical plan to qualify an alternate OSD DP site and/or critical excipient/packaging component source-formulation and process transfer, engineering runs, PPQ readiness, comparability strategy, and CPV set up-in partnership with Regulatory CMC, QA&C, and Supply Chain.
• Own DP tech transfer, scale up, PPQ strategy, and execution for OSD processes (e.g., blending, granulation, compression, coating, and packaging).
• Define, implement, and maintain the commercial DP control strategy and CPV plan, including in process controls, release strategy, and stability support.
• Drive process robustness and continuous improvement at CMOs; lead and coach investigations (deviations, OOS, OOT, complaints) to root cause with sustainable corrective actions.
• Partner with Regulatory CMC by providing technical data packages, comparability assessments, and PPQ summaries to support site addition variations, post approval changes, and lifecycle updates for OSD Drug Product.
• Partner with QA&C to supply technical inputs for audits, PAI readiness, and closure of technical actions from deviations and CAPAs.
• Partner with External Supply / Supply Chain on CMO selection, contracts, campaign planning, packaging strategy, and inventory/safety stock, providing the technical plan and readiness timelines.
• Establish dashboards for yield, throughput, Right First Time, OTIF, scrap, and CoGs; trend process and CPV data from DP CMOs.
• Lead cross functional operating routines and governance with internal stakeholders and external partners.

Qualifications

• BSc/MSc in Pharmaceutical Sciences, Chemical Engineering, Materials Science, or related discipline.
• 10+ years in small molecule Oral Solid Dose Drug Product from late stage development through commercial manufacturing with CMOs.
• Proven experience in leading DP tech transfer, scale up, PPQ, commercial control strategy, and CPV.
• Early career on plant OSD manufacturing exposure (granulation, compression, coating).
• Strong GMP and ICH Q8-Q12 working knowledge (Q9/Q10 applied to DP lifecycle management).
• Demonstrated DP process robustness: CPP/CMA definition across OSD unit operations, dissolution control, specification setting, and excipient/component strategy.
• Hands on with investigations and RCA (OOS/OOT, deviations, complaints) and continuous improvement at external DP sites.
• Comfortable with statistics, DoE, SPC, and CPV data trending for OSD manufacturing and packaging.

Travel: domestic and international up to 25%.

Cytokinetics is an Equal Opportunity Employer.