- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control , Biologics is responsible for late development stage through commercial biologic products including ... or related field) + 10+ years of analytical development and quality control experience with complex biologics spanning late-stage development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and contribute to budgeting, cost control , and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct ... QC team for timely project completion and regulatory compliance. **Department** **:** Global Quality Control - GQC- Biologics **Job Responsibilities** **:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Senior Director - Biologics /Small Molecules Microbiology Quality Control ** **Foster City, CA** ... **Key Responsibilities:** The QC Microbiology Senior Director is vital role for the success of Clinical...vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control… more
- Merck (West Point, PA)
- …Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Down Stream Process Lead within the Enterprise Go To ... Market (EGTM) team, part of the larger Biologics Large Molecule Science and Technology (LMS&T) team. This role will serve as a scientific and technical resource for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Senior Director in Biologics Analytical Development (Pivotal and Commercial)** **Foster ... City, CA** The **Senior Director in Biologics Analytical Development (Pivotal and...accountabilities. + Extensive experience with analytical method development and control strategies of biologics products. + Well… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and inspections. + Proactively develop and sustain strong relationships with CMOs, Quality Control , Quality Assurance, External Manufacturing, Regulatory ... aspirations. Join Gilead and help create possible, together. **Job Description** **Executive Director , Global Biologics MSAT** The Global Biologics MSAT… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for success and evaluates performance against metrics + Partners with Gilead's Biologics Quality , Process Development and Outsourced Manufacturing groups to ... the care of patients with life-threatening diseases. **Role and Responsibilities:** The Director , Development Biologics Tech Operations in the Pre-Pivotal … more
- Lilly (Indianapolis, IN)
- …antibody-like proteins, as well as some antibody containing bioconjugates. The Senior Director Foundry Operations Biologics is directly responsible for managing ... quality and continuous improvement focused mindset within the organization. The Senior Director Operations Biologics is also a member of the Foundry Lead… more
- AbbVie (Irvine, CA)
- …Senior Director will be responsible for leading the global Biologics Analytical R&D organization supporting AbbVie's neurotoxin pipeline which includes novel and ... Director will advance fundamental understanding of neurotoxin critical quality attributes (CQAs), excipient-toxin interactions and degradation mechanisms. He/she/they… more
- Merck (West Point, PA)
- …Safety, Process Development, Technical Services, Utilities and Validation. The Executive Director , Biologics Drug Substance Commercialization (BDSC) will report ... controls strategies that are optimized across the dimensions of cost, quality and speed. Correspondingly, the Biologics Drug Substance Commercialization… more
- Merck (Rahway, NJ)
- **Job Description** The Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... scientific role tasked with working closely with the group Director to define group strategy and to lead a...chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs). We are looking for… more
- BeiGene (Hopewell, NJ)
- **_General Description:_** Establish a stability program in Quality Control for clinical and commercial phase biologics products in accordance to FDA/EU ... scientifically sound GMP test data in accordance to predefined protocols. Oversee the Quality Control sample management program. Develop and implement quality… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control , including ... and cGMP compliance. + Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. + Interpreting scientific data and… more
- Charles River Laboratories (Malvern, PA)
- …passionate about. **Job Summary** The Senior Director Global Head of Biologics Testing Quality will provide direction and leadership as regulatory Subject ... Matter Expert in Biologics Testing Quality Systems and provide guidance...pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/ Quality Control /Regulatory Affairs. Minimum of 5 years… more
- BeiGene (Harrisburg, PA)
- …biologics regulatory CMC overarching strategies for alignment, * Lead or/and oversee biologics CMC change control regulatory CMC impact assessment and ensure ... is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …experience and a MS in a relevant field of study.** + Extensive background in Biologics Operations (eg Manufacturing, Quality Control , Quality Assurance) ... their aspirations. Join Gilead and help create possible, together. **Job Description** The Director - QA Compliance, will report to the Executive Director of… more
- Fujifilm (College Station, TX)
- **Position Overview** The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical ... include one or more PQS sub-system: Deviation, CAPA, Change Control , Supplier Quality , Training, Document Control...practices. + Ability to serve as deputy for Senior Director Quality Systems. + Any other duties… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …products. The ideal candidate will have significant experience in the production and quality control of biologics and sterile pharmaceutical products, ... Senior Director , Global MS&T Sterile and Biopharmaceutical Products Date:...Support process development, optimization, and scale-up of sterile and biologics manufacturing processes. + Work collaboratively with internal teams… more
- Bristol Myers Squibb (Devens, MA)
- …is meaningful, consider joining our diverse team! Reporting to the Executive Director , Business Insights and Technology (BI&T)- BioPharma Operating Units, the Sr. ... Director , BI&T, Devens Digital Plant and Site BI&T Lead...BI&T Lead will be directly accountable to the US Biologics Leader and Devens Campus Leader and will be… more
- Fujifilm (College Station, TX)
- …+ Single Use and Process Validation a plus. + Previous leadership experience in Quality Control or Quality Assurance. **_Working Conditions & Physical ... Overview** **_Summary_** **:** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking ** Quality Assurance (QA) Validation - Associate Director ** to oversee… more