Director, Technical Operations API

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.

At Cytokinetics each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious compassionate and collaborative individuals who are driven to make a positive impact.

Own the endtoend technical enablement of Drug Substance (API) supply for Aficamten across an external CMO network. Deliver robust technology transfer scaleup and PPQ readiness commercial control strategy and ongoing CPV to ensure reliable compliant and costeffective supply. Drive process robustness investigations and continuous improvement and serve as the primary technical interface to CMOs.

Operate crossfunctionally: provide data packages and technical summaries in partnership with Regulatory/ CMC QA&C and Supply Chain. Lead the technical plan for dualsourcing (API/critical starting materials) and hand over filing/quality/commercial actions to the owning functions.

Responsibilities

External Manufacturing / Technical Operations

• Lead onboarding and technical oversight of CMOs for Drug Substance; input to MSAs SoWs and KPIs.
• Dualsourcing technical enablement: Lead the technical plan to qualify an alternate API/RSM /KSM sourceprocess & method transfer engineering runs and PPQ readiness comparability/CPV setupin partnership with Reg CMC (filings/variations) QA&C (audits/release) and Supply Chain (commercials/capacity).
• Own tech transfer scaleup PPQ strategy and execution; define/maintain the commercial control strategy and CPV plan.
• Drive process robustness and continuous improvement at partners; lead/coach investigations (deviations/OOS/OOT) to root cause.

Process & Scientific Leadership

• Own synthetic route and process optimization; set CPPs/CMAs impurity control strategy and DS specifications.
• Define rawmaterial strategy (critical starting materials) and secondsource technical requirements.

Regulatory CMC (Drug Substance)

• Partner with Reg CMC by providing technical data comparability and PPQ summaries to support siteaddition variations and lifecycle updates.
• Reg CMC owns dossier authorship/submission and Health Authority interactions (queries approvals).

Quality & Compliance (with QA)

• Partner with QA&C to supply technical inputs for audits/PAI readiness and to close technical actions from deviations/CAPAs.
• QA&C owns Quality Agreements external audits product release/COA and QMS governance.

Supply Cost & Risk

• Partner with External Supply / Supply Chain on supplier selection contracts campaign planning and inventory/safetystock strategy; provide the technical plan and readiness dates.
• External Supply / Supply Chain owns commercial budget capacity and the master supply risk register; Tech Ops owns the technical risk register and mitigations.

Analytics / Data & Ways of Working

• Establish dashboards for yield/throughput/RightFirstTime/OTIF/CoGs; trend process and CPV data from CMOs.
• Lead crossfunctional routines and governance with internal stakeholders and partners.

Qualifications

Education & Core Experience

• MSc/PhD in Chemical Engineering Organic/Process Chemistry (or related).
• 15 years in small-molecule API from late-stage development to commercial manufacturing with CMOs.
• Proven leadership of tech transfer scale-up PPQ commercial control strategy and CPV for API.

Technical Depth

• Strong GMP and ICH Q7 Q8Q12 working knowledge.
• Demonstrated process robustness: CPP/CMA definition impurity control specification setting and raw-material/CSM strategy.
• Hands-on investigations/RCA (OOS/OOT/deviations) and continuous improvement at external sites.
• Comfortable with statistics/DoE/SPC and data trending for CPV.

Cross-Functional Interfaces (scope clarity)

• Regulatory CMC: Generate high-quality technical content/data packages (comparability PPQ summaries) and respond to HA queries; Reg CMC owns dossiers & submissions.
• QA&C: Provide technical inputs to audits/PAI readiness and CAPAs; QA&C owns QAA release and QMS.
• External Supply / Supply Chain: Provide the technical plan and readiness dates; they own commercials capacity and the master supply risk register

Vendor & Network Leadership

• CMO governance (KPIs SoWs) performance management and second-source technical enablement experience (preferred).

Plus Factors

• Early-career on-plant API/DS manufacturing exposure (strong plus).
• Prior site-addition / dual-sourcing technical packages; solvent recovery/cost-down achievements.
• Multi-region experience (US/EU/ICH) additional European language(s).

Ways of Working

• Crisp technical writing; influence without authority; decisive data-driven; comfortable with 25 30% travel.

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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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Cytokinetics is an Equal Opportunity Employer