- Merck & Co. (Rahway, NJ)
- …Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... (PSCS)The FLEx sterile facility supports the formulation and filling of clinical and developmental supplies for sterile products, including critical program needs… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs...Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing...Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical… more
- BioAgilytix (Durham, NC)
- …clear communication, and aligning project deliverables with client timelines and expectations. Lead assay development, validation , and sample analysis of ... for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass… more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical , ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … lead the statistical support in safety signal detection, validation , characterization and reporting in collaboration with safety programming team, CSPV, ... from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical...scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for… more
- Merck & Co. (North Wales, PA)
- …designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or ... management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Genmab (NJ)
- …join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until ... proof of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Merck & Co. (San Francisco, CA)
- …DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline ... execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
- Genmab (NJ)
- …the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital ... team at ATO B20. The NPI Lead is expected to have ownership over the Technology...vital to the impact that ATO B20 with a clinical and commercial product mix has to the network.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical production and strategically prepares for commercial supply of a CAR-T ... for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Merck & Co. (South San Francisco, CA)
- …at our South San Francisco, California research facility. -The successful candidate will lead efforts to implement and validate novel imaging methods in in vivo ... of disease biology and develop novel biomarkers to inform clinical trial design. -You will be also a part...meet drug discovery program timelines Support the development and validation of novel imaging biomarkers in animal models of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision risk, drive action plan development and ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking ... methodologies to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data… more
- Merck & Co. (South San Francisco, CA)
- …is recruiting a Senior Director, who will serve as the Computational Biology lead for Cardiometabolic Drug Discovery Data Science. We are seeking an experienced ... to generate target/biomarker hypotheses and patient stratification strategies. This role will lead a team of bioinformaticians and data scientists to apply cutting… more
