- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **TITLE:** **Senior Director , Analytical Lifecycle Management - Biologics Quality Control ... biologics drug substances and drug products. The Senior Director collaborates with cross-functional teams, fosters a culture of continuous improvement,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Associate Director , Global External Manufacturing Biologics ensures uninterrupted ... within and external to the organization. Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires intimate collaboration at… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities:** Senior Director , Global External Manufacturing, Biologics will lead an ... managing, training, and mentoring senior-level staff. Experience in leading the Manufacture of Biologics Drug Substance and Sterile Drug Product is a must. This role… more
- AbbVie (South San Francisco, CA)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a ... team of pharmaceutical development scientists supporting the development of therapeutic biologics . The candidate should have extensive expertise in biologics … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Senior Director of Materials Science will spearhead the technical support for selection, ... materials used in manufacturing and analytical testing for all biologics programs at Gilead. They will play an instrumental...will play an instrumental role in all phases of biologics development and will be an integral member of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , Strategic Sourcing and Supplier Management, Biologics DP** **KEY ... RESPONSIBILITIES** The Director , Strategic Sourcing & Supplier Management, Biologics DP owns the strategic business relationship with multiple contract… more
- Gilead Sciences, Inc. (Foster City, CA)
- …impact. Join Gilead and help create possible, together. **Job Description** The Director of Purification Development for Pre-pivotal Biologics will be ... studies. He/She will also be responsible for regulatory strategy for Gilead's biologics entities. This role is expected to work collaboratively with cross-functional… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Executive Director of Cell Culture Development (CCD) will be responsible for leading the ... development and characterization of cell culture processes for biologics programs from the Pivotal and Commercial stages. This responsibility will also include any… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direct impact. Join Gilead and help create possible, together. **Job Description** ** Director , Cell Culture Process Development - Pre-Pivotal Biologics CMC ... Join Gilead and help create possible, together. **Job Description** The Director , Cell Culture Process Development (Pre-Pivotal) will be responsible for leading… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** We are currently seeking an industry leader for a Director , Quality Assurance role, who will report to Executive Director , Supplier ... to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarks + Ensure that the audit agenda is… more
- BeiGene (San Mateo, CA)
- **_General Description:_** + The Director , Clinical Pharmacology will be responsible for developing and executing clinical pharmacology and pharmacometric strategies ... for novel small molecules and biologics assets in the company portfolio. She/He will provide...mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing… more
- BeiGene (San Mateo, CA)
- …engineering, bioengineering, biotechnology, or relevant process development and manufacturing of biologics . + ≥8 years of industrial experience in CMC of ... biologics . Experience with cell therapies is a plus. + Broad understanding of all aspects of CMC including process development, regulatory and quality requirements,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Senior Director , Strategic Sourcing and Supplier Management, Contracting** **KEY RESPONSIBILITIES** ... The Sr. Director , Contracting is accountable for the processes, systems, and...suppliers of APIs, spray dry dispersions, oral solid dosages, biologics , sterile drug products, and/or secondary packaging services as… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director , Medical Writing is responsible for leading clinical regulatory medical writing activities for BeiGene that conform ... INDs, NDAs, BLAs, MAAs and other regulatory submission documents. The Associate Director , Medical Writing is also responsible for mentoring junior writers and… more
- BeiGene (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... geographic areas, and prior experience with both small molecules and biologics . Has sufficient regulatory knowledge to integrate inputs from other countries/regions… more
- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies ... major geographic areas, and prior experience with both small molecules and biologics . + Thorough understanding of drug development process and the pharmaceutical… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... oversight and managing external partnerships and relations. + Experience with biologics and small molecule supply chain. + Understands comprehensive global… more
- BeiGene (San Mateo, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on ... geographic areas, and prior experience with both small molecules and biologics .** **Thorough understanding of drug development process and the pharmaceutical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(eg, Marketing Authorisation Applications [ MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third ... parties, such as regulatory agencies. + Plays a leadership role on PS and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and PS TA functional area support in PV audits and… more
- BeiGene (San Mateo, CA)
- …complex information in well-constructed documents.** **Working knowledge of drug/ biologics development, clinical research, study design, biostatistics, and ... regulatory affairs (eg, FDA and ICH guidelines for various scientific documents) is required.** **Supervisory Responsibilities:** **Supervises and guides the development of direct reports as well as cross-matrix supervision of MWs assigned to support documents… more