Hiring company: Gilead
Sr Research Scientist II - Formulation & Process Development, Oceanside CA
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead has an opportunity for an experienced candidate in our Biologics Drug Product Development group at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with scientific expertise in protein formulation and drug product process development, oversight of GMP drug product manufacturing, and global regulatory CMC (INDs, IMPDs, BLAs, MAAs).
Essential Duties and Job Functions:
- Lead phase appropriate formulation and drug product process development for monoclonal antibody and other recombinant protein modalities (eg, bispecific, fusion, etc.)
- Lead the design and execution of development studies that employ a variety of analytical techniques, including HPLC, capillary electrophoresis, spectroscopy, and visible/subvisible particulates to evaluate formulations and primary container closure systems, as well as in-use subcutaneous and intravenous (IV) delivery systems and conditions.
- Lead the development, characterization, and troubleshooting, of drug product manufacturing unit operations, such as bulk storage freezing / thawing, compounding / mixing, sterile filtration, vial and syringe filling, lyophilization, as well as manual and automated visual inspection
- Lead the drug product technology transfer of parenteral drug product to clinical and commercial manufacturing sites, provide person-in-plant support for on-site process development studies and during GMP manufacturing, as well as assist in quality investigations as necessary.
- Participate on and lead cross-functional CMC teams
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, review development summary reports, and author sections of regulatory submissions.
- Be an effective communicator of ideas, project goals and results to team members across functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
- Lead, motivate, and develop the people in their group.
- Routinely make decisions affecting direction of project to ensure project timelines are met.
Knowledge, Experience and Skills:
- PhD in scientific or engineering discipline with 5-7+ years of relevant industry experience in Protein Formulation and Drug Product Process Development
- Experience in late stage development (process/product characterization and process validation)
- Experience authoring BLA/MAA filings
- Experience working with CMC teams
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer