Sr. Manager - Director, Quality Control (QC) & Analytical Development (AD)Cytokinetics
Responsible for strategy and leadership of the Company?s QC/AD operations, including oversight of CROs and CMOs for all related activities to ensure compliance with GLP and cGMP.
Build and maintain a robust QC/AD program to support all product pipelines from early development to commercial.
Develops stability indicating analytical methodologies and controls method transfers and validations.
Establishes and justifies all specifications for API and drug products.
Supervises coordinates, and documents analytical and qualitycontrol testing of API and drug products and collaborates effectively with QA representatives to manage the initiation, investigation, and closure of related deviations.
Ensures all stability programs are development stage appropriate and managed effectively, as well as controlling operations to maintain reference standards.
Oversees trend analysis and reporting of QC data in conjunction with manufacturing.
Provides assistance with in-depth technical reviews for manufacturing and supports global CMC regulatory submissions.
Drive improvements in QC policy, practices, and compliance and interface effectively with other scientific disciplines (e.g., Quality Assurance, Analytical Chemistry/DMPK, Process Chemistry, and Formulation Development).
Supports operational budgets, cost controls and resource planning to meet corporate strategic objectives.
Represents QC/AD at interdepartmental meetings.
M.S. or Ph.D. in Analytical Chemistry or related discipline with 7-10 years of pharmaceutical development industry experience in QC/AD
Demonstrated record of excellence, 5+ years in leadership and management of QC/AD in a small molecule drug development industry environment
Experienced in leading QC/AD teams in support of drug discovery and non-clinical development
Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation
Excellent interpersonal, communication and decision-making skills
Expert knowledge of cGMP and GLP compliance and regulations and experienced in manufacturing batch record review, product specifications, stability programs and other QC/AD activities
Demonstrated ability to manage external contractors to meet or exceed Company goals
Proficient in writing technical reports and QC/AD sections of CMC regulatory documents
Demonstrated ability to effectively manage multiple products and projects
Demonstrated ability for systematic methods of paper and electronic document organization, retention, and retrieval
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.