- 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)
- …implementation and continuous improvement of Device Development and Device Technical & Engineering Leader processes, procedures, and tools.Maintain a high level ... from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination Product Working Groups to… 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)
- …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. (Durham, NC)
- …Director, External Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other ... : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and...OEB 4 / OEB 5 compounds is a plus. New Product Introductions - Knowledge of Pharmaceutical… 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
- 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
- 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
- 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. (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 (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 ... are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience...which has proven experience in the biotechnology industry. This leader will be responsible for managing the site quality… 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
- 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
- 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
- Repligen (Clifton Park, NY)
- OverviewThe Operations Leader role for Repligen is a senior position and is responsible for site related functions, including all of Operations and Manufacturing ... involved, collaborating with headquarters functions for harmonization for matrixed roles. Lead all operations at the site, including Planning, Procurement,… more
- Merck & Co. (Rahway, NJ)
- …packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving ... third party manufactures of our Company's products across drug substance, drug product and packaging operations.- The organization helps launch and supply our… 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
- Twist BioScience (South San Francisco, CA)
- …with project risk managementReport project status, risks, and escalations Work with product owners to help manage backlogs and new project ... and Scrum Master, you will work closely with stakeholders, both business and software engineering , and play a crucial role in coaching and guiding the Scrum team(s)… more
- Repligen (Boston, MA)
- …technology to enhance bioprocessing workflows.Repligen Corporation is a global leader in bioprocessing technology and innovation, committed to redefining the ... contract manufacturing organizations.Market Analysis: Conduct market analysis to identify new opportunities and trends within the bioprocessing industry. Monitor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array ... functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Leads, coaches and delivers a holistic, effective… more