- AbbVie (South San Francisco, CA)
- …organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Biologics Drug Product Development department is within the ... Francisco, CA. This group is responsible for formulation and drug product process development that... biologics formulations. + Prepare and characterize biologic drug product formulations using various assays (visual… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product . + Proven track record in ... talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development . Broad experience in… more
- Genentech (Oceanside, CA)
- …with a strong emphasis on safety, compliance, reliability, and cost-effectiveness in drug substance, drug product and respective process analytical ... Global Biologics organization plays a pivotal role in the development and commercialization of the company's biologic portfolio, which includes standard… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for our Pivotal and Commercial Biologics Characterization team in Biologics Pivotal and Commercial Analytical Development . Broad experience in analytical ... excipient strategies. + Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Scientist** . Once onboarded, the successful candidate will lead and contribute in development of formulation and drug product processes for innovative ... evaluations. + Demonstrate expertise in analytical and biophysical characterization and drug product process development techniques; provide on-the-job… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product . + Proven track record in ... and driving innovation in HCP monitoring to support process development and product characterization. Additionally, the ideal...host cell DNA, and other process related impurity method development and techniques commonly used for drug … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …cell culture, purification, and formulation + Proven track record in process development , scale-up, and technology transfer of biologics products + Strong ... **Position Overview:** The Senior Director, MSAT Biologics provides strategic and technical leadership for all...Regulatory Affairs, and Operations to align strategies and optimize product lifecycle management + Lead root cause investigations for… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …+ Support formulation and drug process development , including formulation development , Drug Product manufacturing process development , and ... motivated, attentive, and self-driven candidate to join our team, ** Biologics Pivotal Formulation and Process Development ,** as... product intermediate and drug product characterization. + May support manufacturing of development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …QC test method execution and leading the analytical lifecycle management of Commercial biologics drug substances and drug products. **Department** ** ** ... and CTLs. + Experience leading or participating in the development of product specification setting for commercial...instrumentation and GMP systems/software (eg LIMS, QMS, Empower) for biologics drug substances and drug … more
- Gilead Sciences, Inc. (Foster City, CA)
- … and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires collaboration ... at the Team Leadership level with the Development , Quality, Regulatory, Analytical, Supply Chain, and ...and routine supply **Qualifications** + Experienced in sterile large-molecule drug substance or large-molecule drug product… more
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