Associate Director, CMC Analytical Chemistry
Locations:
South San Francisco, California
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R91
About Cytokinetics:
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 treatments for diseases where cardiac muscle performance is compromised. The company is advancing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job Purpose:
The Associate Director (AD) role is both hands-on and leadership-focused, delivering analytical support for approved and pipeline products, mentoring junior team members, and developing best practices to streamline operational procedures.
Responsibilities:
Analytical Development:
Lead, track, and document Analytical Development activities for approved or pipeline products.
Provide analytical support for Process Chemistry and Formulation Development teams.
Manage and oversee all analytical laboratory functions at CMOs for assigned compounds or products.
Conduct analytical technical reviews of QC data for release, stability, and method validation activities.
Develop strategies and methodologies for analytical method validation, stability studies, and batch release testing.
Manage transfer and/or validation of analytical methods to CMOs and independent contract laboratories.
Lead the development and management of stage-appropriate stability programs.
Establish and justify specifications for drug substances and drug products.
Regulatory and Compliance:
Provide analytical expertise for deviations and OOS/OOT investigations alongside Quality Assurance.
Draft technical sections for IND/IMPD/CTD documents supporting global CMC regulatory submissions.
Ensure expert compliance with cGMP standards, ICH guidelines, and HA regulations related to pharmaceutical manufacturing and testing.
Cross-Functional Collaboration:
Interface effectively with Quality Assurance, Regulatory CMC, Analytical Chemistry/DMPK, Process Chemistry, and Formulation Development teams.
Support operational budgets, cost control, and resource planning.
Represent Analytical Development at interdepartmental meetings.
Qualifications:
Education:
Advanced degree in Analytical Chemistry or a related discipline.
Experience:
Minimum 8+ years of pharmaceutical development experience in Analytical Development and Quality Control.
Proven leadership and management experience in a small molecule drug development environment.
Expertise in chromatographic methods and modern analytical instrumentation.
Skills:
Highly organized, self-motivated, and capable of managing multiple products and projects simultaneously.
Excellent interpersonal communication and decision-making skills.
Proficient in technical writing for reports and regulatory submissions.
Familiar with Electronic Notebook systems for creating, searching, and retrieving records.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $185,000 - $226,000 per year.
Final compensation may vary based on internal equity, geographic region, job-related knowledge, skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics welcomes candidates from diverse backgrounds. Applicants are encouraged to apply even if they do not meet every qualification. If you are passionate about contributing to Cytokinetics' mission and believe you can add value, you are encouraged to apply.
Important Information:
Cytokinetics upholds scientific integrity, ethics, and patient-centric decision-making. All legitimate offers will come from an official Cytokinetics email domain (cytokinetics.com) after a formal interview process.
Cytokinetics does not:
Conduct interviews through non-standard text messaging applications.
Request personal financial information before an official offer is accepted and verified.
Request candidates to purchase equipment during the hiring process.
If you are unsure about the authenticity of an offer or receive suspicious communication, contact: talentacquisition@cytokinetics.com.
For more information, visit: www.cytokinetics.com
Equal Opportunity Employer
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