Director, Technical Operations API at Cytokinetics

Dublin, County Dublin, Ireland

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CardiovascularIndustries

Requirements

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
Strong GMP and ICH Q7, Q8–Q12 working knowledge
Demonstrated process robustness: CPP/CMA definition, impurity control

Responsibilities

Lead onboarding and technical oversight of CMOs for Drug Substance; input to MSAs, SoWs and KPIs
Lead the technical plan for dual-sourcing (API/RSM/KSM)—process & method transfer, engineering runs, PPQ readiness, comparability/CPV set-up—in partnership with Reg CMC, QA&C, and Supply Chain
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
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
Partner with Reg CMC by providing technical data, comparability and PPQ summaries to support site-addition variations and lifecycle updates
Partner with QA&C to supply technical inputs for audits/PAI readiness and to close technical actions from deviations/CAPAs
Partner with External Supply / Supply Chain on supplier selection, contracts, campaign planning and inventory/safety-stock strategy; provide the technical plan and readiness dates
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
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 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 (API/critical starting materials) and hand over filing/quality/commercial actions to the owning functions
Own the technical risk register and mitigations

Skills

Technical Operations

API Manufacturing

Technology Transfer

Scale-up

PPQ

CPV

Process Robustness

CMO Management

CMC

Regulatory Affairs

Supply Chain

Dual Sourcing

Process Validation

Investigations

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

Land your dream remote job 3x faster with AI

Try Jobo Free