SUMMARY/JOB PURPOSE:

The incumbent will be responsible for the day-to-day activities directed to support development and manufacturing of biological (antibody drug conjgates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing process development, DP process technical ransfer, activities to support preparation and administration of DP and selection and development of primary container closure. The work would include but not limited to outlining, designing, executing, managing and/or leading various activities in house or at CRO/CMO including maintaining up to date documentation and records.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Designing, execution and timely managing development activities both internally and at contract laboratories with best practices in support of Exelixis developmental from discovery to IND and BLA.

• Good understanding of biophysiucal characterization and analytical methods for biologics development: e.g., DLS, SEC, CE, cIEF, ELISA, LC-MS, Peptide Mapping.

• Provide strategic and tactical input toward assessing and identifying any at risk or potential problematic areas within drug product development and manufatcuring activities at CRO and CMOs, and provide effective solutions to mitigate before these areas result in any issues.

• Perform hands-on work, documentation and data review.

• Work closely with functional and cross functional CMC and non CMC colleagues as well as with contract labs to directly oversee activities.

• Author, prepare and review relevant sections of CMC submissions in support of regulatory filings.

• Collaborate effectively within CMC (analytical, drug substance), QA and RA and other internal fucntions and outside contract laboratories with excellent communication to maintain strong relationships.

• Stay current with journal articles and changing regulatory requirements regarding analytical testing.

• Help to identify and draft work instructions/SOP for relevant analytical assays.

SUPERVISORY RESPONSIBILITIES:

• May provide scientific guidance and direction to junior staff.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemstry, Physical Chemistry or a related field and 0 or more years of related industrial experience; or,

• Equivalent combination of education and experience.

• Experience/The Ideal for Successful Entry into Job:

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemstry, Physical Chemistry or a related field and 0-2 years of related industrial experience is preferred. MS with 5-7 years and BS with 7-9 years of relevant industrial experience is preferred.

• Experience (including hands on) 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 is preferred.

• Experience with sterile DP manufacturing including technical transfer is preferred.

• Experience (including hands on) in Analytical Development in the pharmaceutical industry and/or academia is preferred. Experience developing analytical methods, specifically HPLC methods, for testing biological drug substances and drug products is preferred.

• Experience conducting stability studies is preferred.

• Experience working with contract laboratories is preferred.

• Hands on experience with analytical instrumentation including HPLC is preferred.

• Experience in biologics drug product development is preferred.

• Experience in formulation development, DP process development, container closures and devices, preparation and administration of biological and/or novel biological modalities is preferred.

• Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives is preferred.

Knowledge/Skills:

• Drug product development and/or manufacturing

• Knowledge of CMC biologics processes

• Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle

• Ability to collaborate with 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

• Understanding of cGMP quality and regulatory requirements for CMC biologics is preferred

• Sets goals with understanding of priority and impact to the program, department, and organization

• Excellent interpersonal, presentation, and written communication skills

• Creative thinker and 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

#LI-MB1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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.