Director, Biologics Analytical Development (CMC Biologics)

SUMMARY/JOB PURPOSE:

The Director, Analytical Development manages the analytical activities across multiple CMC biologics areas to support the development and manufacturing of biological drug candidates at external sites. The incumbent utilizes his/her technical expertise in CMC analytical areas such as method development, qualification, and specification setting to advance CMC development and manufacturing for pre-IND and in-clinic biological molecules. Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities. The individual works independently and in cross-functional teams and works effectively with third-party CDMOs and partners.

Essential Duties And Responsibilities:

• Build and lead an analytical team responsible for the analytical activities at external contract development and manufacturing organization (CDMO) and control testing laboratories (CTL) for biologics CMC product development.

• Own one or more projects with hands-on responsibility as the analytical point of contact in the interaction with CDMO/CTL

• Take ultimate accountability for the team’s success on the assigned projects to set up the phase-appropriate analytical programs per the project timelines. This includes analytical method development, qualification, validation, reference standard qualification, stability setup, specification, analytical comparability, product characterization, etc.

• Provide analytical support to the process development and manufacturing team on the process development activities at CDMO sites

• Build a process to ensure a seamless handover of the routine GMP testing and batch release review responsibility to the QC Operation team after the CDMO/CTL is set up for GMP testing. Support QC in the communication with CDMO/CTL to align the Exelixis change control and deviation investigation activities

• Guide direct reports on various technical issues. Monitor the team performance and dynamics and provide feedback as needed

• Escalate significant issues from the responsible team to the group head and/or relevant project teams in a timely manner and drive the mitigation or problem-solving activities

• Build collaborative relationships with other stakeholders including DS and DP Manufacturing, Process Development, Project Manager, Quality Assurance, and Regulatory Affairs

• Adjust and align the roles and responsibilities across different functions as needed

• Support the IND/IMPD writing, review, and regulatory responses

• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring and analysis of ongoing manufacturing/testing, late-stage product development strategy, and longer-term development efforts

Supervisory Responsibilities:

• Hire, train, and manage new members of the responsible analytical team

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 13 years of relevant industry experience; or,

• Master’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 11 years of relevant industry experience; or,

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 8 years of relevant industry experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Demonstrated Experience in managing the CDMO/CTL for clinical or commercial biological products

• Extensive experience in outsourcing the analytical method development, transfer and qualification, product characterization, stability, and cGMP initiation activities for biological IND projects.

• In-depth experience in a wide range of batch release methods such as cell-based assays, ELISA, residual HCP, qPCR, HPLC, CE, appearance, A280, chemical impurities, excipients test, etc. Experience in QC microbiology methods such as sterility, bioburden, endotoxin, and environmental monitoring is a plus

• Demonstrated experience in people management, conflict resolution, and building consensus

• Experience in later-stage analytical development, method bridging, commercial validation, BLA authoring, and review is a plus

• Experience in antibody-drug conjugates and bispecific antibodies is a plus

Knowledge/Skills:

• Broad and deep knowledge of CMC biologics analytical program and phase-appropriate development strategy

• 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

• 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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Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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 $194,000 - $275,500 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.