Scientist IV, Biologics Drug Product jobs in United States
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Exelixis · 5 hours ago

Scientist IV, Biologics Drug Product

Exelixis is a biotechnology company focused on developing innovative medicines for cancer treatment. The Scientist IV will be responsible for executing activities related to the development and manufacturing of biologics drug products, including formulation development and process technical transfer.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Design and execute in-house laboratory experiments to support biologics development
Perform biophysical characterization and analytical assays, including but not limited to DLS, HIAC, MFI, DSC, SEC, freeze dry microscope, karl fisher, CE, and cIEF
Design and conduct formulation studies, stability studies, compatibility studies, and container closure selection studies, as well as other drug product development and manufacturing-related activities
Perform lyophilization of biologics and related process development studies
Prepare documentation, review data, and present findings to functional teams and leadership
Maintain laboratory instruments by scheduling preventive maintenance, managing inventory, and troubleshooting issues to ensure optimal functionality
Collaborate closely with internal CMC teams (conjugation, analytical, drug substance), QA, RA, and cross-functional colleagues, as well as external contract laboratories, ensuring clear and effective communication
Maintain strong relationships with internal and external partners through proactive and professional engagement
Stay current with scientific literature and evolving regulatory requirements related to formulation and drug product development
Contribute to the development and drafting of work instructions and SOPs for relevant methods

Qualification

Formulation developmentBiophysical characterizationLyophilization developmentAnalytical instrumentationCMC biologics processesMulti-taskingCollaboration skillsInterpersonal skillsCreative thinkingProblem solving

Required

BS/BA in Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Physical Chemistry, or related discipline and a minimum of five years of related experience; or
MS/MA in Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Physical Chemistry, or related discipline and a minimum of three years of related experience; or
Equivalent combination of education and experience
Experience in formulation development and biophysical characterization of biologics (mAbs, ADC etc.) and novel biological modalities such as gene and cell therapies in industry or in academia
Experience with lyophilization development, DP process development, container closures and devices, preparation and administration of biological modalities
Experience conducting stability studies
Hands on experience with analytical instrumentation
Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives
Formulation and Drug product development and/or manufacturing
Knowledge of CMC biologics processes
Ability to collaborate and work 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
Excellent interpersonal, presentation, and written communication skills
Creative thinker and complex problem solver

Preferred

Experience in formulation development and biophysical characterization of biologics (mAbs, ADC etc.) and novel biological modalities such as gene and cell therapies in industry or in academia is preferred
Experience with lyophilization development, DP process development, container closures and devices, preparation and administration of biological modalities is preferred
Experience conducting stability studies is preferred
Hands on experience with analytical instrumentation is preferred
Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives is preferred

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

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Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.

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 Company
Total Funding
$514M
Key Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M

Leadership Team

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Michael Morrissey
President and CEO
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Christopher Senner
Executive Vice President and CFO
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Company data provided by crunchbase