- Gilead Sciences, Inc. (Foster City, CA)
- …and verbal) skills. The ideal candidate would also have: + Experience with CMC requirements for drug development and manufacturing of a range of product modalities. ... + Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework, and of global biopharmaceutical manufacturing sector and trends in that sector. + Familiarity with FDA and ICH guidelines… more
- Astellas Pharma (South San Francisco, CA)
- …team members, and cross-functional research teams in pharmacokinetics, safety, CMC (Chemistry, Manufacturing, and Controls), as well as external collaborators. ... 3. Prepare patent specifications related to non-clinical pharmacology data for patent filings of drug candidates as needed. 4. Proactively conduct investigations to propose new projects based on cancer biology strategies. 5. Provide leadership, mentorship, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with FDA/EMA guidance for preclinical and early clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + ... Possess strong business acumen to align drug development and launch strategies with commercial goals, assess financial implications, and support data-driven decision-making across the portfolio. + Demonstrated strong business acumen to evaluate R&D investments… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... participate in or lead clinical development contributions to due diligence or other business development activity. * Serves as a champion for innovation in consumer eye care. Actively solicits opinion leader interactions related to the disease area(s);… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …in Foster City, CA **Preferred Qualifications** + Industry experience in biologics CMC development + Experience working in a laboratory setting strongly preferred + ... Strong desire and ability to learn new skills and excel in a fast-moving, dynamic and evolving environment. + Ability to work collaboratively with others. + Organized and strong ability to work independently in multiple complex workflows. The salary range for… more
- BeOne Medicines (San Mateo, CA)
- …and with external partners. + Collaborate with Regulatory Affairs, Clinical, CMC , Quality, Safety, and Commercial functions to shape and execute regulatory ... strategies. + Anticipate regulatory trends, changes, and challenges, and proactively adapt project plans to align with evolving global requirements. + Contribute to portfolio prioritization, resource allocation, and business planning processes. + Lead, mentor,… more
- Stantec (Sacramento, CA)
- …Data Centers is strongly preferred. - Knowledge of applicable codes and standards, including CMC , CPC, CFC, CBC, NFPA, and ASHRAE, as well as LEED and green building ... requirements - Ability to apply logic, reasoning, and organizational skills to structure concepts and ideas into deliverables. - Ability to demonstrate a credible and trustworthy presence through professionalism and demeanor. - Strong oral and written… more
- Gilead Sciences, Inc. (Foster City, CA)
- …years, or BS/BA with 5+ years of industrial experience in biologics CMC development. . Hands-on laboratory experience required. . Experience with formulation ... development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired. **People Leader Accountabilities:** *Create… more
- AbbVie (South San Francisco, CA)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Author scientific publications and present at ... scientific conferences. Qualifications This is a hybrid position 3/week onsite Qualifications: + PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master's Degree or equivalent education and typically 8+ years of… more
- BeOne Medicines (Emeryville, CA)
- …have interactions with supporting functional areas such as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory ... Compliance. This position will also play a key role in getting authoring teams within BeOne to adopt authoring in Veeva RIM and help to enable efficiencies therein. Provide leadership to Regulatory Submissions Operations Management teams (eg Regional… more