- 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)
- …collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to ... Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within...all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with… more
- Merck & Co. (Durham, NC)
- …pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support ... new facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, lyophilization, product inspection,… more
- Merck & Co. (Durham, NC)
- …, and daily operations;Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, ... or need.Supply - Support Tier.- Exercise judgment and decision making to ensure quality product is reliably produced while managing cost.- Responsible for… more
- Merck & Co. (Durham, NC)
- …compliance goals through a risk-based approach ( Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change ... Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary...Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic… more
- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Sciences, Phytochemistry, Process Control Automation, Process Optimization, Process Simulation, Product Formulation, Safety Compliance, Standard Operating Procedure… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...constructive and timely feedback towards performance expectations and goals Lead site training program Develop, coach, and build competencies… more
- Catalent, Inc. (Kansas City, MO)
- …with Manufacturing, Engineering, Maintenance, EHS and Quality to optimize productivity, safety , product quality and supply reliability for commercial ... Manufacturing Product Lead Position Summary Catalent, Inc....improvement projects to reduce product cost, improve product quality , improve process safety … more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be ... team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of...regulatory guidance and quality standards related to product release and safety .Current Employees apply HERE… more
- Eisai, Inc (Nutley, NJ)
- …want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the ... a key opportunity for a talented, passionate marketer to lead important and innovative commercial work streams for a...across HCPs, Consumers, and SOC to drive adherence and safety as patients start therapy. Partner with Market Access,… more
- Aequor (Hicksville, OH)
- …for delivery with a power and pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met and to ... maintain the efficient flow of product through the production process. Individual will complete SAP...as needed. Independently utilizes required Personal Protective Equipment and Safety Gear and performs a safety check… more
- Nuwellis, Inc (Eden Prairie, MN)
- …transfer to manufacturing, and process/ product improvements. This position is responsible for product safety and quality in all stages of product ... its Aquadex SmartFlow ultrafiltration therapy. The Principal Design Assurance & Quality Engineer partners with Marketing, Clinical, Regulatory, R&D and Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including...provide input for the vision and direction of AI product deployment and governance to ensure responsible and efficient… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Analog Devices (Wilmington, MA)
- …, Productivity, and Delivery. Determine when to stop an activity if a risk to product quality or safety occur. Work closely on an overlapping schedule ... to learn the requirements to perform reliability operations critical for ADI product qualification, production support, and customer quality satisfaction. This… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves hands-on… more
- Merck & Co. (Rahway, NJ)
- …the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Eisai, Inc (Nutley, NJ)
- …scientific literature for potential adverse event reports, report findings to Product Safety within established timeframes. Qualifications: Advanced healthcare ... to the company's products. The incumbent will contribute to the development of high- quality Medical Information deliverables within the team and will be a visible… more
- Eisai, Inc (Exton, PA)
- …collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management ... document review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product , and… more
