Senior Manager, Biologics Process

SUMMARY / JOB PURPOSE :

The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive late-stage process development, technology transfer, Process characterization, Process Validation and manufacturing of biological drug candidates with a focus on Biologics including mAbs, Bi-specifics and Antibody Drug Conjugates (ADCs). The Senior Manager utilizes their technical expertise in biologics process and / or bioconjugation process chemistry and process engineering to advance CMC development and manufacturing for in-clinic biologics and bioconjugate molecules. A strong technical focus is critical to ensure the speed, cost effectiveness and technical quality of our CMC activities. The individual works independently and in cross-functional teams, leads and drives selected technical initiatives and CMC projects, and works effectively with internal and third-party CDMO partners. The individual has familiarity with analytics and formulation as they are working closely with these groups in addition to a general working knowledge of Biologics CMC.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Apply technical knowledge and expertise in biologics process and / or bioconjugation, late-stage process development and technology transfer, process characterization and process validation to advance biological drug candidates across the product life cycle
• Support transfer, development and scale-up of biologics process and / or bioconjugation from early-stage CMC , into late-stage CMC to enable late stage clinical and commercial production
• Collaborate with internal and external partners in analytical and formulation groups to advance CMC biologics programs
• Deliver technical support to ensure successful clinical manufacturing, and to develop and implement process improvements as programs advance
• Lead and support various elements of late-stage CMC development activities, such as risk assessments, process characterization, control strategy, and process validation
• Analyze, interpret, present and document complex technical information such as development data or manufacturing and testing trends, in support of CMC objectives
• Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work
• Contribute to CMC regulatory strategies and submissions, and quality documentation
• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring, and analysis of ongoing manufacturing / testing, and longer-term development efforts.

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

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JOB COMPLEXITY : WORKING CONDITIONS :

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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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $165,500 - $235,500 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.

DISCLAIMER

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.