SUMMARY/JOB PURPOSE:
The Principal Scientist (CMC Biologics) will focus on formulation development, drug product development and manufacturing of biological drug candidates. The Principal Scientist will utilize their technical expertise in drug product function area, provide formulation and process characterization to support regulatory filings from pre-IND through BLA stage. The individual will work independently and in cross-functional teams and work effectively with third party contract development manufacturing organizations (CDMOs) and partners.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Develop liquid and lyophilized formulations, for antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs)
Working with CDMOs, design and execute DP related development studies, including pre-formulation, formulation, and short-term stability in support of excursions during shipping and handling
Provide support to Tox and clinical studies by evaluating in-use stability and material compatibility at the relevant settings
Provide oversight ensuring successful technical transfer and drug product batch manufacture at CDMOs
Collaborating with CMC team including analytical, and quality, contribute to stability program set up for mAb intermediate, drug substance (DS) and drug product (DP) and support on-going stability programs
Apply technical knowledge and expertise related to formulation and drug product development and manufacturing to advance biological drug candidates across the product life cycle
Contribute to CMC regulatory submissions, and quality documentation
Work to establish internal lab capabilities at Exelixis in CMC Biologics
Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring and analysis of ongoing manufacturing, and longer-term development efforts.
SUPERVISORY RESPONSIBILITIES:
Supervises, hires, trains, provides work direction, and problem-solving assistance for less experienced scientists. Also oversees the daily operations of other staff.
May provide scientific direction to internal staff of external teams (CROs) to enable project progression
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of eleven years of relevant drug discovery experience; or,
Master's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of nine years of relevant drug discovery experience; or,
Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of five years of relevant drug discovery experience after completion of post-doctoral training; or,
Equivalent combination of education and experience.
Experience:
Experience designing and implementing experiments in formulation development, as well as DP process development and manufacturing
Lyo development and/or manufacturing experience with biologics is strongly preferred
Experience planning and executing in-use stability and long-term stability studies
Hands on experience and through understanding of analytical methods for biologics characterization, including chromatographic, electrophoretic, and biophysical methods
Demonstrated experience working with CDMOs
Experience with documentation of experiments, analyzing data, generating high-quality technical reports, and Quality/Regulatory information
Additional experience with the development and manufacturing of ADCs, and/or bispecifics in the DP form is desired
Additional experience in building and/or expanding a formulation laboratory for biologics is desired
Knowledge/Skills: Strong technical knowledge in formulation, drug product process development and manufacturing for biologics
Strong scientific acumen in drug product function area, including aseptic technologies, container closure compatibility and formulation characterization technologies
General and working knowledge of CMC development and cGMP quality and regulatory requirements for biologics
Ability to collaborate with cross-functional teams and work effectively 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
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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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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $137,500 - $195,000 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.
