Associate Director, CMC Analytical Chemistry
2 days ago
Cytokinetics is a pioneering biopharmaceutical company dedicated to developing innovative treatments for cardiovascular diseases. As a key member of our team, you will play a crucial role in driving our mission forward.
Job SummaryWe are seeking an experienced Associate Director to lead our Analytical Development team. In this role, you will be responsible for delivering high-quality analytical support for our pipeline products, mentoring junior team members, and developing best practices to streamline operational procedures.
Key Responsibilities- Lead and track Analytical Development activities for supported pipeline products
- Provide analytical support for Process Chemistry and Formulation Development as needed
- Manage and oversee all analytical laboratory functions at CMOs in support of assigned development compounds
- Conduct analytical technical review of QC data generated at CMOs for release, stability, method validations, etc.
- Work with CMOs to develop strategies and methodologies for analytical method validation, stability studies, and batch release testing
- Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories
- Provide ongoing analytical assistance to CMOs
- Lead the development and management of stage-appropriate stability programs
- Establish and justify all specifications for drug substances and drug products
- Provide analytical expertise for deviations and OOS/OOT investigations
- Draft technical paragraphs for IND/IMPD/CTD supporting global CMC regulatory submissions
- Interface effectively with other scientific disciplines
- Support operational budgets, cost controls, and resource planning
- Represent the team at interdepartmental meetings
- Ph.D. in Analytical Chemistry or related discipline with 8+ years of pharmaceutical development industry experience in AD and QC
- Demonstrated record of excellence in leadership and management of AD/QC in a small molecule drug development industry environment
- Experience in leading AD/QC teams and projects in support of all stages of drug development
- Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation
- Highly organized and self-motivated
- Excellent interpersonal communication and decision-making skills
- Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations
- Demonstrated ability to manage external contractors
- Proficient in writing technical reports and AD/QC sections of CMC regulatory documents
- Demonstrated ability to effectively manage multiple products and projects
- Experience in creating, searching, and retrieving records in an Electronic Notebook system
Cytokinetics is an Equal Opportunity Employer. We offer a competitive salary range of $182,000-$222,000 USD and a comprehensive benefits package. If you are passionate about making a difference in the lives of patients and caregivers, we encourage you to apply.
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