Process Development Jobs in Livermore, CA (NOW HIRING)

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Job Description

Scientist, Purification Process Development - Pre-Pivotal Biologics - Foster City, CA

The Scientist, Purification Process Development (Pre-Pivotal) will lead and execute purification process development laboratory experimentation for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II) with minimal supervision. He/she will also design, lead and execute laboratory experimentation for purification process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.

Key Responsibilities:

• Establish and maintain a state-of-the-art purification lab that enables rapid new biologics entities manufacturability assessment, purification process development and scaleup.

• Lead experimental design for purification unit operation(s). Plan and execute purification process development laboratory studies with minimal supervision. Support process scaleup and implementation in internal and external GMP facilities.

• Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author and review experimental protocols and reports.

• Support and may lead process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Provide oversight at internal and external manufacturing facilities as person-in-plant. Provide technical support for manufacturing atypical event investigations.

• Support non-GMP pilot lab operations. Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).

• Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.

• Lead purification platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline.

• Contribute to workflow improvements for screening lead molecules with optimal developability.

• Participate in cross functional initiatives as needed.

• Adhere to department budget and all training, compliance and safety requirements.

Basic Qualifications:

• Ph.D. in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field with 0+ years or M.S. with 4+ years or B.S. with 6+ years industrial experience in biologics purification development.

• Hands-on laboratory operations experience bench and pilot scale chromatography, TFF, VF and depth filtration.

• Experience in pre-pivotal stage purification process development, scaleup and implementation in GMP and non GMP manufacturing facilities.

• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).

Preferred Qualifications:

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Working knowledge of lab automation, data management, data science, knowledge management and data protection.

• Knowledge in single-use manufacturing technology and cGMP guideline is a plus.

• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.