Exelixis · 1 week ago
Commercial Drug Product Packaging Director
Alameda, CA
Full-time
Hybrid
Director/Executive
$166K/yr - $236K/yr
11+ years expExelixis is a company focused on developing innovative cancer therapies, and they are seeking a Commercial Drug Product Packaging Director to oversee packaging operations across their network of Contract Manufacturing Organizations. The role involves developing processes for packaging oversight, leading commercial packaging operations, and providing technical support during project activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develop robust processes and systems for oversight of packaging operations at Exelixis CMO network
Lead all aspects of commercial packaging operations at CMO’s
Lead external tech transfers for commercial packaging operations
Be the Subject Matter Expert (SME) for packaging of oral solid dosage products at Contract Manufacturing Organizations
Be the “person in plant” as needed to manage critical packaging operations at CMO’s
Provide on-site technical support during project activities such as implementation/qualification of new packaging line equipment and introduction of component changes
Work closely with Quality colleagues, providing technical expertise to drive CMO deviations and investigations to successful resolution
Utilize technical expertise to troubleshoot packaging process issues
Be the SME for serialization implementation and ongoing support at CMO’s
Review and approve Master Packaging Records and executed packaging batch records, protocols, and reports
Have a solid understanding of regulatory strategy associated with packaging changes
Closely track and monitor packaging performance including packaging deviations, packaging batch record review timelines etc., and propose improvements to processes where efficiencies can be introduced
Implement internal department SOPs to ensure that production oversight at CMOs is well documented with the best processes
Directing work at external CMO’s, Consultants or 3rd party
Manages others in a matrix environment (dotted line reporting)
Qualification
Required
Bachelor's degree in related discipline and a minimum of 13 years of related experience; or
Master's degree in related discipline and a minimum of 11 years of related experience; or
Equivalent combination of education and experience
Extensive experience in troubleshooting packaging process issues, as well as participating in and leading investigations associated with packaging operations
Experience providing CMO on-site technical support, including oversight of packaging issues and investigations
Experience working with internal and external partners, both domestic and international
Experience with packaging artwork review and approval
Experience overseeing serialization implementation including validation and communications qualification
Demonstrates expert knowledge of oral solid dosage packaging operations (bottles and blister) including bottle filling and blistering, cartooning, printing and serialization
Applies creativity, innovation and expert skills to contribute to Exelixis portfolio of small molecule commercial products
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing
Performs a variety of complicated tasks with a wide degree of creativity and latitude
Has complete understanding and wide application of technical principles, theories, concepts, and techniques related to oral solid dose packaging
Has good general knowledge of other related disciplines
Applies strong analytical and business communication skills, be able to present data and results concisely per relevant audience
Proficient with broad use computer applications such as MS Office and specialized applications as needed for job
Thorough understanding of cGMP and regulatory strategy associated with manufacturing changes including SUPAC, ICH and CFR's
Travel required – 15% of domestic/international travel required
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
GlobeNewswire
2026-01-23
2026-01-18
2026-01-12
Company data provided by crunchbase