- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … more
- Merck & Co. (Rahway, NJ)
- …pipeline to our patients around the world.This new leadership role within our Digital Manufacturing Value Team (MVT) that will work across, and in partnership ... and product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team , the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA by overseeing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards… more
- Merck & Co. (Rahway, NJ)
- …product design, development, and evaluationSelf-motivated and work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with subject-matter experts on the DD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the ... manufacturing processes of (mAb, Drug Substance, Drug Product, or...first CPV. The candidate is leading the Site Launch Team with its associated sub-teams. Accordingly, the candidate is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role ... oversight for trending of quality compliance metrics Work in a collaborative team setting with quality counterparts that include Manufacturing Operations,… more
- Merck & Co. (Rahway, NJ)
- …vendors.Drive and influence the technology and innovation strategic roadmap for the clinical end to end data flow in partnership with functional stakeholders, ... backlog and prioritizing them based on changing requirements.Defining the vision for the team 's business case and problem statement and be able to translate them… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSolPlatform Business Lead (Capability Lead ) in the Platform Team plays a crucial role in analyzing business requirements, facilitating ... and ensuring the successful implementation of platform solutions. The Platform Business Lead will collaborate closely with the platform team , product managers,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead ... treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the...including viable/non-viable air and surface sampling, related to Raritan manufacturing processes, either for clinical trials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as SOPs, work instructions. Develop positive relationship with the QA team , Quality Control, Information Technology, Maintenance, Manufacturing personnel, ... working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of ... production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment....1 year of experience leading, supervising, or managing a team preferred Prior experience in manufacturing , quality,… more
- Aequor (NJ)
- …studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate. Proactively ... Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain...Translates broad strategies into specific objectives and action plans. Team and individual leadership ( lead courageously). Oral… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The Quality Systems Lead role ... supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and...portfolio of ongoing projects. Ability to work with and lead others in a team environment. Experience… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of ... clinical development at our company's Research laboratories. TMB laboratories...is seeking a highly motivated candidate to join our team . The individual will play a critical role in… more
- Merck & Co. (Rahway, NJ)
- …the strategic planning and execution for product development and worldwide regulatory submissions. Lead a team of statisticians and the statistical programmers to ... methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing . This individual will partner ... attitude under minimal supervision. Proactive and continuous improvement oriented. Ability to lead with influence. cGMP manufacturing . Able to manage shifting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing . This individual will work within ... Trainer (2nd shift) as part of the Technical Operations team based in Raritan, NJ. Role Overview Operations Process...minimal supervision Proactive and continuous improvement oriented Ability to lead with influence cGMP manufacturing Able to… more
- Merck & Co. (North Wales, PA)
- …on document-specific cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.Applies knowledge of clinical ... is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical… more
