- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal ... Scientist in Pre-approval Pharmaceutical CMC is responsible for developing and implementing ... CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products… more
- Formation Bio (New York, NY)
- …a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) activities related to biologic product development at Formation Bio. This is ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …/ our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other… 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)
- …explore opportunities for digital innovation.Develop current and future landscapes for CMC overlaid with digital capabilities.Work closely with Product Line Leads to ... and externally).- Viewed as a credible and trusted partner.Understanding of the CMC business area in DSCS and Commercialization.- Familiar with the interdependence… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities . - Responsible for authoring the Clinical Supplies section of the… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… 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)
- …a history of peer-reviewed publications and presentationsKnowledge of biologics CMC developmentAdaptability and agility to prioritize and deliver complex objectives, ... and communication skills PREFERRED EXPERIENCE & SKILLS: Leadership of CMC development teamsContinuous biomanufacturing and high-throughput microbioreactors integrated with… more
- Merck & Co. (Rahway, NJ)
- …a history of peer-reviewed publications and presentations- - Knowledge of biologics CMC development - Adaptability and agility to prioritize and deliver complex ... skills - - PREFERRED EXPERIENCE & SKILLS: - - Leadership of CMC development teams - C ontinuous biomanufacturing integrated with process-analytical technologies -… more
- Merck & Co. (Rahway, NJ)
- …Combination Product Working Groups on cross-functional teams at the highest-level CMC teams and governance.Serve as key point-of-contact with potential external ... device designers, developers, and suppliers for selected device technology platforms.Oversee and serve as an integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk… more
- Merck & Co. (Rahway, NJ)
- …partner functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team (LT). ... This role also involves building long-term capability and expertise in launch readiness across the network to ensure sustainability and scalability of future product launches.The Head, Global Biologics Network Launch Readiness will:Lead and manage… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... & ensuring stable supply of product.Primary activities include, but are not limited to:-Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical… 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
- Insmed Incorporated (San Diego, CA)
- …level of work quality.Ability to present scientific data and concepts to CMC team members and leadership.Knowledgeable of analytical techniques used to determine ... product quality and characterization of biologics.Travel RequirementsThis position is based onsite in our San Diego locationSalary Range$111,000 - $156,133 a yearCompensation & BenefitsAt Insmed, we're committed to investing in every team member's total… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will support electronic batch record (EBR) updates ... and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X).Key Responsibilities Support eBR development, modeling, and deployment in MESCoordinate with other departments to gather… 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
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate… more
- ACROBiosystems Inc. (New York, NY)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company… more
