- Merck & Co. (Rahway, NJ)
- …is critical for understanding business opportunities, outcomes and execution.The DSCS Digital Program Manager will:-Work with the DSCS Digital Leadership Team, ... in a scientific-related discipline strongly preferredRequired Experience and Skills:--Research, manufacturing , and project/ program management experience in pharma… more
- Merck & Co. (Rahway, NJ)
- …regulatory BLA sections and working with external contract organization for development and or manufacturing .Working knowledge of statistical methods for ... Job DescriptionOur Manufacturing Division is a team of dedicated, energetic...Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of drug substance… more
- Merck & Co. (Rahway, NJ)
- …skills and/or project management certification or relevant training program /close mentoring.Behavioral Competency Expectations: Strong leadership skills ... can sign contracts and manage budgets).Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH… more
- Merck & Co. (Rahway, NJ)
- …supplies under good manufacturing practice (GMP) settings. - Providing analytical leadership not only on drug development pipeline projects, but also ... of synthetic routes, to inform the selection of early development and market formulation compositions and manufacturing ...written and oral communication skills, as well as strong leadership and interpersonal skills are necessary to qualify for… more
- Merck & Co. (Rahway, NJ)
- …collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Research & Development Division is ... the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.- The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …Company's network of GMP pilot facilities, commercialization facilities, and process development labs, across our research division and manufacturing division, ... modality pipeline to our patients around the world.This new leadership role within our Digital Manufacturing Value...the purpose and aspiration of our Company's digital (Chemistry, Manufacturing , and Controls) CMC program to set… more
- Merck & Co. (Durham, NC)
- …committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to ... strong interpersonal, communication, and collaboration skills responsible for providing cycle development and PQ for equipment and systems supporting bulk biological… more
- Merck & Co. (North Wales, PA)
- …assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing , and marketing of medical drugs… more
- Insmed Incorporated (Bridgewater, NJ)
- …years of Project/ Program Management experience with proven management and/or leadership experience in an R&D, manufacturing /operations or commercial context ... Director of Program Management will provide cross-functional operational and program management leadership , strategic thinking, and business acumen for the… more
- Merck & Co. (Rahway, NJ)
- …will be expected to apply his/her knowledge of product design and development ; manufacturing process development , qualification, and validation; and, ... the program -specific design controls process and design history file development .Author and review relevant portions of the regulatory submissions (INDs, IMPDs,… more
- Novo Nordisk Inc. (Boulder, CO)
- …RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from ... a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … program , Policies and SOPs and other master documentsSupport Engineering and Manufacturing in the development of critical process parameters and provide ... Position Summary:Oversee and lead the validation program for production equipment and processes used to...and process risk assessments in conjunction with Quality and Manufacturing subject matter expertsOversee development and execution… more
- Merck & Co. (North Wales, PA)
- …across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing , and marketing of medical drugs… more
- Merck & Co. (North Wales, PA)
- Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development Division (R&D). The Project Managers in GPAM are core members of ... the CMC Integrated Project Management organization (CIPM) serves on the Development and Commercialization Teams (DCTs) responsible for developing and executing an… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... of standards related to security, regulatory, clinical, commercial, and manufacturing processes to establish a culture of compliance regionally.Strengthens Eisai… more
- Lundbeck (Bothell, WA)
- …Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC ... & Validation Team.The Lu-SBP team leads and supports the development of new product candidates from cell line ...through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress… more
- Merck & Co. (Rahway, NJ)
- …all launch markets.Embed the commercial perspective and patient insights within the development program and with cross-functional teams to create a profile ... treatment will be responsible for supporting all commercial elements related to late-stage development and launch success for an asset projected to reach ~$6B in… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical ... which include oversight of raw material qualification, lab investigations, stability program , etcProvide oversight of QC equipment program , which includes… more
- Merck & Co. (Boston, MA)
- …excellence in Translational Immunology with a rich understanding of drug development , leadership , recruitment capabilities, management skills to direct a ... strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .-The AVP provides strategic oversight for the early clinical space,… more
- Merck & Co. (Rahway, NJ)
- …new therapeutic area for our company; where no regulatory guidance exists; where the program is extremely accelerated; is an Alliance program ; there are multiple ... documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global… more
