Director, Technical Operations Drug Product
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job Purpose
Own the end-to-end technical enablement of Oral Solid Dose (OSD) Drug Product supply for Aficamten and future pipeline candidates across an external CMO network. Deliver robust formulation and process technology transfer, scale-up and PPQ readiness, commercial control strategy, and ongoing CPV to ensure reliable, compliant, and cost-effective DP supply. Drive process robustness, investigations, and continuous improvement, and serve as the primary technical interface to Drug Product CMOs.
Operate cross-functionally: provide data packages and technical summaries in partnership with Regulatory/CMC, QA&C, and Supply Chain. Lead the technical plan for dual-sourcing (DP sites, critical excipients, and packaging components) and hand over filing, quality, and commercial actions to the owning functions.
Responsibilities
External Manufacturing / Technical Operations
- Lead onboarding and technical oversight of Drug Product CMOs (OSD); provide technical input to MSAs, SoWs, and KPIs.
- 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 (filings/variations), QA&C (audits/release), and Supply Chain (commercials/capacity).
- 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.
Regulatory CMC (Drug Product)
- 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.
- Regulatory CMC owns dossier authorship, submissions, and Health Authority interactions (queries, approvals).
Quality & Compliance (with QA)
- Partner with QA&C to supply technical inputs for audits, PAI readiness, and closure of technical actions from deviations and CAPAs.
- QA&C owns Quality Agreements, external audits, product release/CoA, and QMS governance.
Supply, Cost & Risk
- 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.
- External Supply / Supply Chain owns commercial budget, capacity, and the master supply risk register; Tech Ops owns the DP technical risk register and mitigations (process, formulation, component, and site risks).
Analytics / Data & Ways of Working
- 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
- MSc/PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science, or related discipline.
- 15+ years in small-molecule Oral Solid Dose Drug Product from late-stage development through commercial manufacturing with CMOs.
- Proven leadership of 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 leadership of 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.
- Regulatory CMC: Generate high-quality technical content and data packages (comparability, PPQ summaries) and support HA queries; Reg CMC owns dossiers and submissions.
- QA&C: Provide technical inputs to audits, PAI readiness, and CAPAs; QA&C owns Quality Agreements, release, and QMS.
- External Supply / Supply Chain: Provide technical plans and readiness dates; they own commercials, capacity, and the master supply risk register.
- Strong experience in OSD CMO governance, performance management, KPIs, and second-source DP site or component technical enablement (preferred).
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Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
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Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer