- Formation Bio (New York, NY)
- …Collaboration & External Partnerships Partner closely with analytical development, manufacturing , quality , and regulatory teams to ensure seamless execution ... the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing , and Controls (CMC)...Establish and manage key relationships with CDMOs and other external partners to support development and manufacturing … more
- KIND Snacks (New York, NY)
- …teams (Consumer Insights, New Product Development, Operations, Project Management, Quality , Manufacturing , Packaging, etc) to execute innovation projects ... for a variety of occasions. All of KIND's products lead with a nutrient-dense first ingredient - like nuts...able to inspire & motivate teammates, cross-functional colleagues, & external partners to deliver quality work. A… more
- Li & Fung Limited (New York, NY)
- …Build and foster strong relationships with external vendors and manufacturing partners, ensuring quality and innovation throughout the development process. ... to inspire and guide a team while directly engaging with customers and external partners. Key Responsibilities: Lead trend research, development, and design of… more
- Merck & Co. (Rahway, NJ)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Merck & Co. (Rahway, NJ)
- …to set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both ... extensive knowledge in medical device engineering, particularly in the design, manufacturing , verification, validation and associated quality and regulatory… more
- Merck & Co. (Rahway, NJ)
- …launch manufacturing .To achieve this, this highly experienced leader will lead cross-functional launch readiness teams at each site, drive the execution of ... site leadership to drive preparedness for agile and efficient multi-product manufacturing operations.Establish and lead a cross-functional launch readiness… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... development of formulation, manufacturing process, and primary packaging to enable phase appropriate.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Rahway, NJ)
- …both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program ... Familiarity with data analytics/visualization software . - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard… more
- Merck & Co. (Rahway, NJ)
- …& Manufacturing , in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics in ... on tight timelines, in a rapidly changing environmentExperience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Merck & Co. (Rahway, NJ)
- …surveillance.This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work ... ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the… more
- Merck & Co. (Rahway, NJ)
- …early and late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director, Biologics Process Development (BPD) within the ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- …deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The ... and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... established reputation for scientific excellence supported by publications and external presentations is expected.Qualifications -Education:Ph.D. in analytical chemistry/biochemistry or… more
- Merck & Co. (Rahway, NJ)
- …into insight and business decisions.Primary Activities:Interfaces with internal and external groups, gains consensus and contributes to reliable and effective ... data collection systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations and… more
- Merck & Co. (Rahway, NJ)
- …and payers in order to optimize market access and patient outcomes.Main Responsibilities: Lead a team in HEDS to develop and implement health economic models and ... analyses to demonstrate the value of our Company vaccines. Lead , manage, mentor, and provide strategic direction to a team of 4-6 health economists and outcomes… more
- Merck & Co. (Rahway, NJ)
- …and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating ... build deep expertise in CMC and the interface with our Company's manufacturing division.Understanding of the existing IT portfolio of systems and products.-… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... and Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews… more
- Merck & Co. (Rahway, NJ)
- …execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization ... operations ramp-up of commercial and clinical capacity.Build strong partnerships with Manufacturing , Supply Chain, Engineering, MS&T, and Quality to ensure… more
