Sr Director, Analytical Chemistry (Small Molecule)
The incumbent will be responsible for the oversite of development and validation of analytical operations for Exelixis Investigational New Drug Substances and New Drug Products (small molecules and ADC drug linkers). The activities would include but not limited to the oversite of all analytical development activities, management of the analytical development staff, CMO oversite, management of interactions with other functional groups internal and external, review and approve analytical CMC regulatory submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage analytical development activities both internally and at contract laboratories with best practices in support of Exelixis developmental from discovery to NDA.
Manage and oversee the analytical development of antibody drug linkers and bioconjugation.
Contribute effectively towards strategic and tactical development of project plans with key emphasis on analytical aspects and phase appropriate development.
Will provide oversight for release and stability testing of clinical drug substance and drug product.
Works closely with contract labs to directly oversee transfer of methods, validation and QC testing to ensure they are executed successfully and with best practices.
Oversight to contract labs for protocols, deviations, investigations, CAPA’s, reports, stability data, trending, specification setting, shelf-life/retest dating related to analytical methods and testing, using where applicable, current regression analysis practices and other relevant statistical techniques.
Author, review and approve analytical sections of CMC submissions in support of regulatory filings (Including NDA, MAA, IMPD and IND).
Author -and review relevant sections of CMC submissions in support of regulatory filings. Stay current with changing regulatory requirements regarding analytical testing,
Experience with critical regulatory activities for biologics such as extended characterization, comparability assessments and attribute risk assessments.
Lead efforts to identify and champion new methodologies and technologies for analytical development.
Provides strategic and tactical guidance in managing activities internally and externally to proactively and preemptively avoid technical issues from occurring by building in best practices and mitigation plans up front.
Stay current with changing regulatory requirements regarding analytical testing.
Identify and draft work instructions/SOP for relevant analytical functions.
Provide direction to other individuals.
Supervises, hires, trains, provides work direction, and problem-solving assistance for student.
workers. Also oversees the daily operations of other staff.
Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and
recommends salary increases, promotions, transfers, demotions, or terminations.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
PhD degree in related discipline and fifteen years of related experience; or equivalent combination of education and experience.
15+ years experience in Analytical Development in the biopharmaceutical industry
Subject matter expertise for analytics and characterization of small molecules. Experience in toxin linker technology is a plus.
Experience developing and validating analytical methods, specifically for biological molecules drug substances and drug products.
Experience conducting stability programs
Experience working with contract laboratories is required
Experience with Regulatory requirements and managing analytical related topics across the biologics product life cycle
Comprehensive knowledge of analytical regulatory and compliance issues as they relate to the development of pharmaceutical products
Excellent written and oral communication skills
Ability to work effectively in a team setting
Pharmaceutical Ops & Supply Chain /Alameda:
Environment: primarily working in office
Travel occasionally required – less than 25% travel required
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $209,000 - $296,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.