- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical ... Job DescriptionOur Clinical Development teams manage studies to provide the safety...PDT lead will manage the entire cycle of clinical development , including development strategy, study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.This ... terms to facilitate cross-functional understanding and to support project timelines. Development experience in risk-oriented, regulated environmentsDevelopment project leadership with… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of... of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio… more
- Merck & Co. (Rahway, NJ)
- …complex problems. Experience in one or more of the areas of Drug Substance development , Drug Product development , Clinical Supply management or Analytical ... Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development , and Clinical Supply across all modalities. We… 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, ... The incumbent will also have to demonstrate domain expertise in sterile product development and collaborate effectively with multiple stakeholders across both… more
- Merck & Co. (Rahway, NJ)
- …years of experience in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry preferred - ... Job Description Job Description: - The drug development Project Manager is part of Global Project...Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering… more
- Merck & Co. (Rahway, NJ)
- …with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch.- ... to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead and set direction… more
- Merck & Co. (Rahway, NJ)
- … and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of ... strategy that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent … more
- Merck & Co. (Rahway, NJ)
- …strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product ... supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small… more
- Merck & Co. (Rahway, NJ)
- …compound(s)/ program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting ... and for supporting all protocol and program cost estimates requested by Product Development Teams.- Responsible for authoring clinical supply documentation in… more
- Merck & Co. (Rahway, NJ)
- …with global scientific leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with ... Research through the global Value and Implementation TeamPartners with the Product Development Team, Global Brand and V&I Outcomes Research leads to define… more
- Merck & Co. (Rahway, NJ)
- … development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Responsibilities:Lead development of new, innovative approaches for product development , generation of experimental designs, execution ... scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good...responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team… more
- Merck & Co. (Rahway, NJ)
- …related to price, value and affordability challenges at the appropriate time of product development and launch. -Partner closely with the cross functional team ... including marketing and Product Development Teams (PDTs), (ex. clinical, CORE and medical affairs), regional and country teams to ensure patient access… more
- Aequor (New York, NY)
- …Stakeholder Management: Collaborate with internal stakeholders, including internal business clients, product and technical development partners, to align project ... of oncology and customer experience principles. Familiarity with digital product lifecycle and role customer experience plays. Attributes: Detail-oriented,… more
- Merck & Co. (Rahway, NJ)
- …tracking, and communicating regarding submissions and approvals to support continued product supply.Participate - in early and late development programs, ... with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND,… more
- Merck & Co. (Rahway, NJ)
- …current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, eg in a pilot and/or factory ... accredited college/university plus at least 8 years of relevant work experience in process development or PhD with at least 4 years of relevant work experience post… more
- Merck & Co. (Rahway, NJ)
- …and disruptive technologies and approaches.- Responsibilities include representing the group on product development teams and defining the potency strategy for a ... interpretation of potency data in context of broader process and product development .- Deep working knowledge of regulatory guidance and quality standards, with… more
- Merck & Co. (Rahway, NJ)
- …necessitates a need for a potential 2nd shift to support clinical supply and product development .- This position is primarily intended for 1st shift, but batch ... FLEx Oral Solid Dosage (OSD) area for clinical drug product manufacturing, located in Rahway NJ. The FLEx OSD...others, fostering a culture of continuous improvement and skills development . Ability to work independently and collaboratively in a… more
- Merck & Co. (Rahway, NJ)
- …impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based ... highly desired.Experience in regulatory compliance expectations across all phases of product development to commercializationExperience with in silico, in vitro,… more