Scientist IV, Biologics Upstream Process Development

SUMMARY / JOB PURPOSE :

The Scientist IV, Biologics Upstream Process Development will independently conduct laboratory experiments with limited supervision to develop cell culture processes and support technology transfer and manufacturing of biological drug candidates.

The incumbent will utilize their technical expertise in upstream / cell culture process development of biologics (therapeutic proteins, antibodies, bispecifics, ADCs, etc) 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 incumbent should have excellent hands-on technical abilities and a strong theoretical grasp of cell culture unit operations and upstream activities such as media / buffer preparation, thawing of cryopreserved cells, cell culture passaging, aseptic sampling and banking, etc.

The incumbent is expected to work in the laboratory full time, including operating state-of-art upstream equipment (ambr250, single-use bioreactors of various scales, cell culture analyzers, etc.

performing routine instrument maintenance, and providing training to peers. The incumbent is also expected to effectively document lab results and draft test methods / SOPs in accordance with company, departmental, and regulatory guidelines.

The individual should have familiarity with downstream 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 :

Under minimal supervision, develop and execute laboratory studies in upstream process development (bioreactor process design, scale up, media and feed optimization, etc) to support unit operation scale up and technology transfers 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.

Maintain complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.

Provide detailed reviews of peer generated data as well as that generated from contracted service providers.

Maintain the inventory of laboratory consumables and clean glassware.

Coordinate vendors service calls for repair and maintenance of laboratory instruments, perform routine maintenance of laboratory instrumentation, and maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.

Work to establish, maintain, and lead internal upstream process development and scale up lab capabilities at Exelixis in CMC Biologics.

SUPERVISORY RESPONSIBILITIES :

None

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Bachelor’s degree in chemistry, biochemistry, biochemical engineering, chemical engineering or related field and a minimum of five (5) 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 three (3) year of relevant drug discovery / development experience; 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 .

Hands-on experience in upstream (mammalian cell culture) process development.

Familiarity with cell line development work flow.

Experience with clone selection, bioreactor process optimization in various formats, and upstream process scale up to at least 2000 L.

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 upstream (mammalian cell culture) process development

Broad and deep knowledge of CMC biologics upstream processes

Working knowledge of therapeutic proteins’ cell line development workflows, downstream 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 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

Excellent organizational and documentation skills and habits

Creative thinker and complex problem solver

JOB COMPLEXITY : WORKING CONDITIONS :

WORKING CONDITIONS :

Environment : primarily working in laboratories

Exposures encountered, such as hazardous materials, and extreme cold.

Limited travel requirement

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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 $100,000 - $141,500 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.