Senior Manager, Biologics Process CMC (External)

SUMMARY / JOB PURPOSE :

The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive technology transfer, 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, biologics drug product, 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, biologics drug product, and / or bioconjugation, technology transfer and process validation to advance biological drug candidates across the product life cycle

Support transfer, development and scale-up of biologics process, biologics drug product, and / or bioconjugation from early-stage CMC , into late-stage CMC to enable 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 phase appropriate CMC development activities, such as risk assessments, 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 :

Supervises, hires, trains, provides work direction, and problem-solving assistance for less experienced scientists. May directly oversee the daily operations of other staff

May provide scientific direction to CDMO project teams to enable project progression

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Bachelor's degree in chemistry, biochemistry, chemical engineering or related field and a minimum of nine years of relevant drug discovery / development experience; or,

Master's degree in chemistry, biochemistry, chemical engineering or related field and a minimum of seven years of relevant drug discovery / development experience; or,

Ph.D. in chemistry, biochemistry, chemical engineering or related field and a minimum of two years of relevant drug discovery / development experience after completion of post-doctoral training; or,

Equivalent combination of education and experience.

Experience :

Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle

Experience in bioprocess, biologics drug product, and / or bioconjugate process chemistry / purification with a working knowledge of CMC process development, technology transfer, and GMP quality requirements

Demonstrated capability to work independently on complex technical problems, effectively in cross-functional teams, and with external CDMOs and partners

Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives

Knowledge / Skills :

Expertise in bioprocess, biologics drug product, and / or bioconjugate process chemistry and purification

Working knowledge of biologics and / or bioconjugate analytics and formulation

Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle

Ability to collaborate with and lead effectively cross-functionally and in a team setting, both internally and with external CDMOs and partners

Ability to multi-task in a fast-paced dynamic environment while delivering high quality work

Strong understanding of cGMP quality and regulatory requirements for CMC biologics

Sets goals with understanding of priority and impact to the program, department, and organization

Excellent interpersonal, presentation, and written communication skills

Creative thinker and complex problem solver

WORKING CONDITIONS :

Environment : primarily working in office

Exposures encountered, such as hazardous materials, extreme cold.

Travel required ~5-10% of time

#LI-MB1

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.