- Merck & Co. (Rahway, NJ)
- …portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / support / oversee clinical ... with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part. Lead / support the development,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, ... is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility... and maintenance groups, as well as outside vendor support .-Provide facility engineering support 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)
- …role 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 ... change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will… more
- Merck & Co. (Rahway, NJ)
- …supply disruptions.Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new technology.Offer on-site support ... Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical...and intermediates. You will be responsible for providing process support , resolving production issues, evaluating process change requests, and… 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
- Twist BioScience (South San Francisco, CA)
- …through innovative, user-centric digital platforms. This role sits at the intersection of product , engineering , and business. You'll lead all aspects of ... Sr Technical Product Manager (Hybrid in South San Francisco or...doing:Engage and communicate effectively with diverse internal teams, including engineering , marketing, sales, operations, and customer support ,… more
- Merck & Co. (Rahway, NJ)
- …inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This ... of product development and design control principles to positively support and influence clinical and commercial combination product development and… more
- Merck & Co. (Rahway, NJ)
- …analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical company. The position requires ... or events directly, and mentor and coach their team to provide on-going support .Essential Duties and Responsibilities: Lead and manage a team of subject matter… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and ... will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile… more
- Merck & Co. (Durham, NC)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies.… 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
- 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
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi- product project execution, manufacturing support , and technology ... projects related to the strategic needs of the company. Partner with global engineering teams to support corporate initiatives and site expansion. Identify and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Repligen (Waltham, MA)
- …the site quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support , root cause ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, ... provide input for the vision and direction of AI product deployment and governance to ensure responsible and efficient...regarding advanced analytics and AI development & consumption. This leader and their team work closely with various business… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …laboratory through manufacturing scale. This role will be part of a Manufacturing Engineering team providing direct support to the manufacturing floor with: ... this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process… more
- Eisai, Inc (Exton, PA)
- …Control, Validation, and other internal (PST) and external functions to support successful product development, including sharing expertise, ensuring optimum ... that is recognized for successfully bringing operations, science, and engineering principles to bear on advancing Eisai's biopharmaceutical programs. Essential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... your potential? The Position The Manager - Market Access Insights assesses product and customer performance for all customer segments and identifies opportunities to… more
