- 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)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... with multiple agencies (FDA, EMA, JNDA, TGA).-Leadership:-Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage 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)
- …/ 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
- 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)
- …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
- 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 ... supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new… more
- Merck & Co. (Rahway, NJ)
- …Have experience working with CMOs and CROs.Have a working knowledge of CMC filing requirements.Demonstrate strong verbal as well as written communication skills and ... ability to work in an interdisciplinary team environment.Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.Self-motivated to take ownership and accountability of issues and drive them to completion.The… more
- Aequor (East Syracuse, NY)
- …knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. ... Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc. Strong written, verbal, presentation, and interpersonal communication skills.… 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. (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
- 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
- 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
- Eisai, Inc (Exton, PA)
- …as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains ... knowledge of established and emerging technologies, utilizes internal and external networks, and leverages prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing operations, science, and… more
- ACROBiosystems Inc. (San Diego, CA)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC ) to keep processes, procedural documents and supporting job aids up ... to date, and to facilitate the use of effective, harmonized processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this role will work closely with process… more
