Exelixis · 3 days ago
Director, Biologics Analytical Development (CMC Biologics)
Alameda, CA
Full-time
Hybrid
Director/Executive
$194K/yr - $276K/yr
8+ years expExelixis is a company focused on the development and manufacturing of biological drug candidates. The Director of Analytical Development will manage analytical activities across multiple CMC biologics areas to ensure the success of projects and maintain high technical quality in collaboration with external partners.
BiotechnologyHealth CarePharmaceutical
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
Hire, train, and manage new members of the responsible analytical team
Qualification
Required
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
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
Demonstrated experience in people management, conflict resolution, and building consensus
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
Preferred
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
Experience in QC microbiology methods such as sterility, bioburden, endotoxin, and environmental monitoring is a plus
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-18
2026-01-12
Company data provided by crunchbase