- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... prepares, coordinates and advances required documentations, in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including… more
- Merck & Co. (Rahway, NJ)
- …concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination Product Working Groups to ... track record of applying analytical skills in product design, development, and validation .-Proven ability to lead team members of diverse skill sets and… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and… more
- Merck & Co. (Rahway, NJ)
- …deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization studies, ... within a regulated supply environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and… more
- Merck & Co. (Rahway, NJ)
- …position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early ... design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with… more
- Insmed Incorporated (San Diego, CA)
- …downstream and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from ... a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations… more
- Formation Bio (New York, NY)
- …the PositionAs AD/Director of Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data Science function, focusing on building ... efforts into scalable products through close collaboration with engineering and product teams. These predictive models will seamlessly integrate with our Clinical… 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 ... product release studies for our San Diego lab. This...You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing… more
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi- product project execution, manufacturing support, and technology transfer ... systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes projects or aspects of… 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
- Merck & Co. (Rahway, NJ)
- …regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality, and support continuous operations. The ideal candidate will have ... strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to manage teams… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Aequor (Thousand Oaks, CA)
- …the manufacturing plant. This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, ... professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive to...Systems, and Digital team at ATO B20. The NPI Lead is expected to have ownership over the Technology… more
- Merck & Co. (Rahway, NJ)
- …testing data, and related documents required to release or reject product . Make independent batch release or reject decisions.-- Conduct independent auditing, ... and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert. Proactively identify, execute and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will range from employee… more
- Repligen (Waltham, MA)
- …but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation , Change Controls, and other product life cycle management ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- Merck & Co. (San Francisco, CA)
- …Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development, and Clinical Supply across all modalities. We ... with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on...more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Provides technical expertise in support of an ... for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor troubleshooting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and… more
