- Twist BioScience (South San Francisco, CA)
- … labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements ... and product specifications.What You'll Be Doing Initiate, author, and maintain...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …of the regional regulatory and business environment, including:API and Drug Product development needsGMP compliance in commercial manufacturingData integrity ... deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization studies,… more
- Eisai, Inc (Nutley, NJ)
- …practices that can help simplify the patient journeyIdentify and ensure training ( product , disease state and compliance training) for promotional speakers and ... issuesOffer feedback on nominating new speakers when applicableCoordinate / facilitate new product and annual compliance trainingWork with Marketing Team for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business… more
- Merck & Co. (Rahway, NJ)
- …Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Merck & Co. (Rahway, NJ)
- …understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding ... robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to develop… more
- Merck & Co. (Rahway, NJ)
- …we leverage technology to enable new organizational capabilities. We are seeking a Product Analyst to be a change agent for our order-to-cash process. This role ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Durham, NC)
- …establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, ... Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and ... manages the development and commercialization of the device constituent and combination product of our company's pipeline of combination products across a variety of… more
- Merck & Co. (Rahway, NJ)
- …the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating ... and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine is accountable for:Directing… more
- Merck & Co. (Rahway, NJ)
- …responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and advanced statistical methods for medical ... device and combination product engineering within the pharmaceutical company. The position requires...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical ... balancing needs of patients & ensuring stable supply of product . - -- Primary activities include, but are not...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative ... mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve… more
- Merck & Co. (Durham, NC)
- …facility will include end-to-end processing of both drug substance and drug product , including product inspection, warehouse, utilities, and quality control ... Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new facility in Durham, NC within Drug Substance,… 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 early ... design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact with… more
- Merck & Co. (Upper Gwynedd, PA)
- …include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of ... all regulatory milestones through product development including assessment of the probability of regulatory...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …project digital programs.Responsibilities include:Planning and allocating resources for cross- product delivery and coordinating with investment Manager to ensure ... current and future landscapes for CMC overlaid with digital capabilities.Work closely with Product Line Leads to ensure the best user experience and the use of… more
- Shimadzu Scientific Instruments (Houston, TX)
- …personnel on proper instrument operation and maintenance. Accurately document all repairs, product failures, and improvements to ensure compliance with company ... standards. Assist in the development and execution of preventative maintenance procedures for instruments. Maintain and control repair parts inventory in the assigned region. EDUCATION AND QUALIFICATIONS: Bachelor's degree in Material Science, Engineering, or… more
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