Associate Biologics Downstream Process Development Director
Location
Alameda, CA | United States
Job description
SUMMARY/JOB PURPOSE:
The Associate Director provides technical leadership and support across multiple CMC biologics areas to drive downstream process development, technology transfer, and manufacturing of biological drug candidates with a focus on therapeutic proteins' purification process development. The Associate Director utilizes their technical expertise in downstream/purification process development of biologics to advance CMC development and manufacturing for pre-IND and in-clinic therapeutic proteins. 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 partners. The individual has familiarity with upstream process development, analytics, and formulation development, as they will be working closely with these groups, in addition to a general working knowledge of Biologics CMC.
ESSENTIAL DUTIES AND RESPONSIBILITIES: - Stay abreast of technical advancements in the CMC area of recombinant therapeutic proteins' purification process development. Leverage new learnings and technologies in Exelixis CMC as appropriate
- Apply technical knowledge and expertise in downstream process development (chromatography purification, viral filtration, TFF, etc), unit operation scale up, and technology transfer to advance biological drug candidates across the product life cycle
- Support transfer, development, and scale-up of purification process technology from research into process development and manufacturing to enable clinical production
- Collaborate with internal and external partners in upstream process development, analytical development, and formulation development groups to advance CMC biologics programs
- Deliver technical support to ensure successful non-GMP and clinical manufacturing, and to develop and implement process improvements as programs advance
- Lead and support various elements of early-stage CMC development activities
- 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, including reports' review and approval
- Contribute to CMC regulatory strategies and submissions, and quality documentation
- Work to establish, maintain, and lead internal downstream process development and scale up lab capabilities at Exelixis in CMC Biologics
- 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: - No direct reports.
- May directly oversee the daily operations of other staff.
- May provide scientific direction to internal staff of external teams (CDMOs) to enable project progression
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: - Bachelor's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of eleven years of relevant drug discovery/development experience; or,
- Master's degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of nine years of relevant drug discovery/development experience; or,
- Ph.D. in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of five years of relevant drug discovery/development experience after completion of post-doctoral training; or, equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job: - Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
- Experience in recombinant protein purification and downstream process development
- Experience developing harvest and clarification unit operations scalable up to 2000 L bioreactor scale.
- Experience with Fast Protein Liquid Chromatography (FPLC) systems (e.g. Akta Avant, Akta Pilot, Akta Ready, etc) for chromatography-based purification development.
- Experience developing scalable chromatography purification unit operations (Affinity, IEX, HIC, SEC, mixed mode, etc).
- Experience developing scalable viral filtration and TFF unit operations.
- Working knowledge of CMC upstream process development, analytical development, formulation development, bioconjugation 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 downstream (purification) process development
- Broad and deep knowledge of CMC biologics downstream processes
- Working knowledge of upstream process development, analytics, formulation development, and bioconjugation process development.
- 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
JOB COMPLEXITY: WORKING CONDITIONS: - Environment: primarily working in laboratories or in office
- Exposures encountered, such as hazardous materials, extreme cold.
- Travel required ~10% of time
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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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $131,500 - $195,500 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.
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