Cytokinetics
Associate Director, CMC Analytical Chemistry
Cytokinetics, South San Francisco, California, us, 94083
Job purpose
AD is both a hands-on and a leadership role within technical operations in delivering analytical support for pipeline products, mentoring, and coaching junior team members for professional growth, and developing best practice standardizing and streamlining operational procedures.
Responsibilities
Lead, track, and document 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 appropriate strategies and methodologies for analytical method validation, stability studies, and batch release testing for maximum efficiency.
Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories. Provide ongoing analytical assistance to CMOs (e.g., method change or optimization)
Lead the development and management of stage appropriate stability programs
Lead theestablishment and justification of all specifications for drug substances and drug products
Provide analytical expertise for deviations and OOS/OOT investigations in concert with Quality Assurance to ensure proper disposition of affected materials
Draft necessary technical paragraphs in IND/IMPD/CTD supporting global CMC regulatory submissions
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 AD at interdepartmental meetings
Qualifications
Ph.D. in Analytical Chemistry or related discipline with 8+ years of pharmaceutical development industry experience in AD, as well as Quality Control (QC)
Demonstrated record of excellence, in leadership and management of AD/QC in a small molecule drug development industry environment
Experienced 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 pertaining to pharmaceutical manufacturing, method validations, 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 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
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AD is both a hands-on and a leadership role within technical operations in delivering analytical support for pipeline products, mentoring, and coaching junior team members for professional growth, and developing best practice standardizing and streamlining operational procedures.
Responsibilities
Lead, track, and document 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 appropriate strategies and methodologies for analytical method validation, stability studies, and batch release testing for maximum efficiency.
Manage the transfer and/or validation of analytical methods to CMOs and independent contract testing laboratories. Provide ongoing analytical assistance to CMOs (e.g., method change or optimization)
Lead the development and management of stage appropriate stability programs
Lead theestablishment and justification of all specifications for drug substances and drug products
Provide analytical expertise for deviations and OOS/OOT investigations in concert with Quality Assurance to ensure proper disposition of affected materials
Draft necessary technical paragraphs in IND/IMPD/CTD supporting global CMC regulatory submissions
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 AD at interdepartmental meetings
Qualifications
Ph.D. in Analytical Chemistry or related discipline with 8+ years of pharmaceutical development industry experience in AD, as well as Quality Control (QC)
Demonstrated record of excellence, in leadership and management of AD/QC in a small molecule drug development industry environment
Experienced 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 pertaining to pharmaceutical manufacturing, method validations, 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 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
#J-18808-Ljbffr