Director, Technical Operations API at Cytokinetics

Dublin, Leinster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Operations, Drug Substance, Process Optimization, GMP, ICH Q7, Continuous Improvement, Regulatory CMC, Quality Assurance, Supply Chain Management, Data Analysis, Process Robustness, Technical Leadership, Vendor Management, Collaboration, Problem Solving, Communication

Industry

Biotechnology Research

Description

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 end‑to‑end technical enablement of Drug Substance (API) supply for Aficamten across an external CMO network. Deliver robust technology transfer, scale‑up and PPQ readiness, commercial control strategy and ongoing CPV to ensure reliable, compliant and cost‑effective supply. Drive process robustness, investigations and continuous improvement, and serve as the primary technical interface to CMO’s. 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 (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. Dual‑sourcing – technical enablement: Lead the technical plan to qualify an alternate API/RSM /KSM source—process & method transfer, engineering runs and PPQ readiness, comparability/CPV set‑up—in partnership with Reg CMC (filings/variations), QA&C (audits/release), and Supply Chain (commercials/capacity). Own tech transfer, scale‑up, 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 raw‑material strategy (critical starting materials) and second‑source technical requirements. Regulatory CMC (Drug Substance) Partner with Reg CMC by providing technical data, comparability and PPQ summaries to support site‑addition 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/safety‑stock 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/Right‑First‑Time/OTIF/CoGs; trend process and CPV data from CMOs. Lead cross‑functional 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, Q8–Q12 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. #LI-HYBRID 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. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer

Responsibilities

Own the end-to-end technical enablement of Drug Substance (API) supply for Aficamten across an external CMO network. Drive process robustness, investigations, and continuous improvement while serving as the primary technical interface to CMOs.