- Programmable Medicine Operatin (Redwood City, CA)
- …drugs. *Experience with analytical method development and various tests for polymer- drug conjugates and/or biologics drug candidates are required. ... and Responsibilities - Essential Functions *Develop various analytical methods. *Test various drug substance/ drug product samples. *Manage, set up, and… more
- Programmable Medicine Operatin (Redwood City, CA)
- …manufacturing Oversee the execution of activities associated with injectable and solid oral drug product development and manufacturing, supporting clinical ... development and subsequent commercialization Manage drug substance and drug product ...or life sciences 9+ years of small molecules or Biologics development and manufacturing experience of injectables… more
- 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
- ThermoFisher Scientific (San Diego, CA)
- …you will drive **revenue growth** by securing **new business opportunities** in ** Drug Product Development and Commercial Manufacturing Services** . ... services, formulation, logistics, and full-scale commercial manufacturing. **Your Role: Business Development Executive ( Drug Product Services)** In this… more
- Abbott (Alameda, CA)
- …metrics/information. **What You'll Work On** + Develop global regulatory strategies for product development and planning throughout the product lifecycle. ... implement and manage appropriate SOPs and systems to track and manage product -associated events. + Actively contribute to the development and functioning… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …join our **Pivotal and Commercial Biologics Characterization** team within ** Biologics Pivotal and Commercial Analytical Development ** . This role requires ... will be driven to contribute to the research and development of biologics addressing unmet medical needs....process reagent testing and control strategies across the late-phase biologics portfolio, with a focus on product … more
- Genentech (South San Francisco, CA)
- …packaging, and analytical development . As an integrated partner within the drug development ecosystem, Global Biologics Pharmaceutical Development ... effective drugs using cutting edge technologies for manufacturing process ( Drug Substance and Drug Product ),...of _in silico_ methods and workflows to support the development of biologics . Our unique focus on… more
- Genentech (South San Francisco, CA)
- … Product ), clinical supply, formulation, device, packaging, and analytical development . Together with our partners, Global Biologics Bioprocess ... **The Position** As part of Pharma Technical Development (PTD) our organization is committed to deliver...well as complex and modified proteins such as antibody drug conjugates and bispecific antibodies. The Roche/Genentech biological portfolio… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Strategy Team(s).** **The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality ... to agency information requests, the Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for… more
- Gilead Sciences, Inc. (Oceanside, 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 help create possible, together. **Job Description** **Principal Scientist in Biologics Analytical Development (Pivotal and Commercial).** United States -… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Design and author **packaging study protocols and technical reports** to support product development , stability, and regulatory submissions. + Draft and review ... **Knowledge Requirements** + Strong technical expertise in **packaging engineering and development methodologies** , with experience across biologics and… more
