- Merck & Co. (North Wales, PA)
- …products that improve human health and business.- -Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization ... Teams (DCTs) responsible for building and executing CMC development plans.--Under the guidance of the CIPM Staff...senior Project Manager (PM) role will be to manage CMC programs, due diligence and business development activities independently,… more
- Merck & Co. (Rahway, NJ)
- …support project management activities to ensure efficient execution and compliance within CMC operations . - The responsibilities of the dCMC Data Analyst include:- ... - - Business Process Mapping and Optimization : Working with Digital CMC and associated business stakeholders, the analyst will map end-to-end processes that produce… more
- Merck & Co. (Rahway, NJ)
- …(DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... options analysis and provides recommendation to governance for endorsement.Represent CMC and effectively communicates across the governance bodies, stakeholders and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Janssen. This effort will extend to representing MSAT on joint technical and CMC committees. The candidate will also be required to collaborate within a cross ... reduction efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior Janssen technical team to achieve… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and… more
- Merck & Co. (Rahway, NJ)
- …translating business strategy to IT strategy, current and future landscapes for CMC overlaid with digital capabilities.-Work closely with Product Line Leads to ... of the external technology landscape and the impact and value to CMC and our Company.-Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst, will support development and implementation of the regulatory ... product status.Required Skills and ExperienceUnderstanding of data within the CMC (Chemistry, Manufacturing, and Controls) domain, including experience in analytical… more
- Merck & Co. (Rahway, NJ)
- …excellence are expected. Job responsibilities: The successful candidate will contribute to CMC development of our company's pipeline, playing an active role in ... both internal and external partners including vendorsKnowledge of biologics CMC development cycleDemonstrated ability for taking initiative, creativity, and… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... communicate results, progress and plans through Line of Business and across the CMC organization. Strive to keep Lundbeck Seattle's Center of Excellence at cutting… more
- Insmed Incorporated (San Diego, CA)
- …senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to ... diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project teams)Ability and experience in the development and… more
- Merck & Co. (Rahway, NJ)
- …cell metabolism and biochemical pathways relevant to bioprocessing.Knowledge of biologics CMC developmentAbility to adapt to and prioritize complex objectives under ... utilization.Excellent interpersonal and communication skills.Preferred Experience & Skills:Leadership of CMC development teams.Experience with continuous biomanufacturing integrated with process-analytical… more
- Merck & Co. (Rahway, NJ)
- …working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong understanding of integration and partnering with Quality, Regulatory, Operations, ... Non-clinical, Clinical, and other functional areas. Demonstrated experience leading cross-functional teams and driving key capability evaluations and technology selection / builds. Excellent verbal and written communication skills, demonstrated initiative,… more
- Merck & Co. (North Wales, PA)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... Administrative Professionals.Position Description/Summary The GPAM Senior Specialist, Value & Implementation Project Manager (VIPM), is a core member of Value & Implementation (V&I) Team, partnering with team leaders to develop strategies and execute our… more
- Merck & Co. (Rahway, NJ)
- …and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for ... biologics.Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and controlExperience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process… more
- Merck & Co. (Rahway, NJ)
- …regulatory, project leaders, manufacturing sites, and other key stakeholders in CMC development and packaging operations.- The successful candidate will model ... ownership and define informed strategies based on analysis of inputs, outcomes, risks, and enterprise-wide prioritization. Primary Responsibilities include: Lead a sterile product group, accountable for people and operations, including managing a sterile… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …negotiate contracts.Lead cross-functional teams and collaborate with Quality, Legal, CMC , MSAT, Manufacturing, Supply Chain, and Regulatory to prepare ... alternate/secondary sourcing strategies.Achieve cost savings objectives for product competitiveness.Support CMO contract negotiations in conjunction with alliance management.Ensure target inventory levels are maintained and reported monthly.Build and nurture… more
- Merck & Co. (Rahway, NJ)
- …engineering, quality assurance, regulatory, and manufacturing teams across the CMC ecosystem. Key collaborative and influential partnerships span across multiple ... stakeholders and organizations within our Research and Development (R&D) and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will support the MES team with electronic ... batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X).Key ResponsibilitiesThis individual will be responsible for gaining the necessary process… more
- Merck & Co. (Rahway, NJ)
- …Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external ... partners for timely execution of work.The successful candidate is expected to collaborate in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to be experienced in mammalian cell culture or purification process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organization. Role will work collaboratively with Operations, IT QA, Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions for the ... organization. This individual will ensure electronic batch records (EBRs) and associated log books, forms, etc can be updated quickly and leverage network capabilities to avoid duplication of efforts across sites.Key Responsibilities Responsible for managing… more
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