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 sourceformulation and process transfer engineering runs PPQ readiness comparability strategy and CPV set-upin 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 Q8Q12 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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Cytokinetics is an Equal Opportunity Employer