Senior Research Scientist I, Purification Development - Pre-Pivotal Biologics
United States - California - Foster City
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Job Description
The Senior Research Scientist I, Purification Process Development (Pre-Pivotal) will be responsible for leading aspects of purification development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I / II).
He / she will also lead projects for purification process technology development, platform process evolution, and purification related regulatory documentation.
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 efficient purification process development. Design and conduct laboratory scale experiments and oversee data generation / data integrity to ensure compliance.
Hands-on laboratory execution is expected.
Transfer process 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. Support manufacturing atypical event investigations.
- Support non-GMP pilot lab operations. Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Author IND / INDa CMC sections. Support Health Authority interactions and product-related inspections.
- Mentor junior team members on purification process development, experimental design and execution as well as process transfer.
- Keep abreast of technology / innovation trends and best industry practices. 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.
- Adhere to department budget and all training, compliance and safety requirements.
Qualifications / Skills / Experience :
Ph.D. in chemical engineering, bioengineering, biochemical engineering, biochemistry or related field with 2+ years OR M.
S. with 8+ years OR B.S. with 10+ years industrial experience in biologics purification development.
- Hands-on laboratory operations experience in 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.
- Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
- Experience in authoring IND / INDa CMC sections.
- Demonstrated ability to collaborate and influence cross-functionally.
- Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
- 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.
The salary range for this position is : $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit : Gilead Benefits.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.
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