Associate Director, Quality Assurance at Cytokinetics

South San Francisco, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Skills

Key technologies and capabilities for this role

Quality AssuranceQuality ControlGMPData IntegrityRegulatory ComplianceStability StudiesLot ReleasePharmaceutical ManufacturingcGMPFDAEMA

Questions & Answers

Common questions about this position

What is the salary or compensation for the Associate Director, Quality Assurance role?

This information is not specified in the job description.

Is this a remote position, or is there a required office location?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires expertise in QA oversight of QC data in a pharmaceutical manufacturing environment, deep knowledge of cGMP, FDA, and EMA regulations, and strong collaboration skills with Technical Operations, Regulatory Affairs, and other departments.

What is the company culture like at Cytokinetics?

Cytokinetics fosters a collaborative environment as a leader in muscle biology, with the role involving close partnerships across departments like Global Supply Chain, Technical Operations, and Regulatory Affairs to support GMP activities for product launch.

What makes a strong candidate for the Associate Director, QA position?

A highly motivated individual with QA leadership experience in pharmaceutical manufacturing, focused on QC data oversight for stability studies and lot release, and skilled in ensuring cGMP compliance across clinical and commercial programs.

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.

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