- Merck & Co. (Rahway, NJ)
- …from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination Product Working Groups to ... activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on development of… more
- 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 ... Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation,...for sterile products, including critical program needs related to new products undergoing process development, new products… 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)
- …is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development… more
- Merck & Co. (Rahway, NJ)
- …managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of ... Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical...and minimize supply disruptions.Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new… more
- Merck & Co. (Rahway, NJ)
- …or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering , with at least 5 years in a leadership or management ... Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within...syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to… 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 ... design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with… more
- Merck & Co. (Rahway, NJ)
- …sites-Dunboyne, Dublin, Carlow, and Wilmington-to successfully execute multiple New Product Introductions (NPIs), Process Performance Qualifications ... to develop and implement 'platform' concepts that accelerate and streamline new product introductions.Develop launch playbooks, knowledge management tools and… more
- Formation Bio (New York, NY)
- …transitioning proof-of-concept efforts into scalable products through close collaboration with engineering and product teams. These predictive models will ... models that drive drug acquisition and portfolio optimization decisions Partner with engineering and product teams to transition proof-of-concept models into… more
- Aequor (Thousand Oaks, CA)
- … products into the manufacturing plant. This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product ... driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At...Systems, and Digital team at ATO B20. The NPI Lead is expected to have ownership over the Technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …creating new medicines.Leadership & People Management: Proven ability to lead cross-functional teams, manage performance, and develop talent. Ability to create ... to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array… 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 ... the interfaces of disciplines to translate breakthroughs into important new medicines and vaccines. This has a direct connection...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… 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 ... leadership at the site level while collaborating closely with our global engineering network to deliver strategic initiatives.The ideal candidate has a strong… more
- Merck & Co. (Durham, NC)
- …Director, External Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other ... and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable...OEB 4 / OEB 5 compounds is a plus. New Product Introductions - Knowledge of Pharmaceutical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process ... corrective actions and related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment… more
- Eisai, Inc (Exton, PA)
- …Drug Substance (DS) / Antibody Drug Intermediate (ADI) production processes for new products in development through their lifecycle (Preclinical through phase III ... also responsible to ensure successful scale-up and technology transfer of new production processes and technologies into the production suites.The Associate Director… more
- Merck & Co. (Rahway, NJ)
- …input to the regulatory submissions including but not limited to Investigational New Drugs, Investigational Medicinal Product Dossier s, and Clinical Trial ... Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who...downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies… more
- Repligen (Waltham, MA)
- …and corrective action plans prior to implementation when required. Review and approve New Product Development Design History Files for the site. Assists with ... 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. (Rahway, NJ)
- …with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Formation Bio (New York, NY)
- …trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as ... proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by...the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related… more
