- Merck & Co. (Rahway, NJ)
- …activities between various device and combination product development, discovery, and formulation development teams.This involves managing a small team of engineers ... the delivery device development team and upstream drug and formulation development teams.Construct initial overall development strategies, timelines, and transition… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …assigned by area management. Clean rooms and equipment needed for compounding- formulation of the product(s).Transfer Material, API, and components to the ... compounding- formulation area.Verify calibration and accuracy of balances and scales.Set up room and equipment for compounding- formulation and… more
- Merck & Co. (Rahway, NJ)
- …is responsible for building the mechanistic understanding of the interplay between formulation composition, process and stability of drug substance and drug product ... well as mentoring other team members in delivering results collaborating with process, formulation and device.- You are expected to use your scientific expertise to… more
- Merck & Co. (Rahway, NJ)
- …design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation ... in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development (including mAbs, ADCs, fusion proteins, combinations… more
- Merck & Co. (Rahway, NJ)
- …and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral ... environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of… more
- Tris Pharma (Monmouth Junction, NJ)
- …Development (AR&D) teams in analytical method development, physical characterization, formulation support, interim validation, pilot release testing and stability ... AR&D teams for all analytical method development, physical characterization, formulation support, interim validation, pilot testing release and stability testing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, ... EU, Japan, China, and other regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This position serves as the primary contact for interactions with… more
- Merck & Co. (Rahway, NJ)
- …closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation , and Commercial Manufacturing while providing a diverse and inclusive ... environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and… more
- Merck & Co. (Rahway, NJ)
- …method development, testing, validation, transfer, stability, extended characterization, and formulation workstreams.Serve as the primary point of contact for key ... stakeholders for all Analytical Research and Development (AR&D).Develop and implement the analytical strategies for large molecule (biologics and vaccines) programs in a matrix team environment to enable delivery on time.Provides multi-disciplinary leadership… more
- Merck & Co. (Rahway, NJ)
- …of the device development activities with the clinical, regulatory, formulation , commercial and other key our Company functions.Represent Device Development ... and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT)Serve as key… more
- Honda Development and Manufacturing of America (Marysville, OH)
- …events and strategic alliances within the organization to contribute to the formulation and enhancement of a strong business plan.* Support in development, ... management and reporting of Business Unit and Center Level Key Performance Indicators and Key Control Points for PSCC* Guidance to PSCC associates for business plan development to improve knowledge and skill set for business plan management and reporting*… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Formulation , Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product ... development and clinical manufacturing facility in Rahway, New Jersey.- This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) though also including spray dried intermediates, liquid… more
- Merck & Co. (South San Francisco, CA)
- …for discovery research, discovery process chemistry, and analytical development, formulation , identification of process impurities, drug substance and product ... degradants, and characterization of other unknown moleculesMeet with department members across functional teams to understand their scientific challenges, propose and develop collaborative solutions with the NMR Sciences team that are aligned with prioritized… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. ... Provide clear direction and guidance to project teams.Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Risk Management Team, participates in company-wide strategic planning, policy formulation , and budgeting. Qualifications: Successful candidates will be able to ... meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Business Administration/Accounting/Finance/Risk Management required- Master's Degree preferred… more
- Merck & Co. (Boston, MA)
- …development (eg pharmacology, cell biology, chemical biology, ADME, formulation , hit discovery, large-scale synthesis, structural biology, safety/toxicology, ... IP).Excellent communication and interpersonal skills and the ability to effectively engage and influence stakeholders at all levels.Commitment to diversity, equity, and inclusion and a track record of promoting and supporting DE&I initiatives.Track record of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …impact therapeutic area business operations processes Resource Optimization: Lead the formulation and oversight of the therapeutic area budget, optimizing resource ... allocation for development and commercialization activities Performance Tracking and Monitoring: Develop KPIs and metrics to track business operations processes and strategic initiatives that execute against strategic objectives. Prepare regular reports to… more
- Merck & Co. (Rahway, NJ)
- …closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation , and Commercial Manufacturing while providing a diverse and inclusive ... environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …development knowledge required. Experience with small molecules and complex formulation development strongly preferred. Familiarity with 505b2 regulatory pathway a ... plus. Ability to build and manage collaborative relationships at all levels (internal and external).Excellent problem-solving skills: proven ability to identify, prioritize and resolve key project and partner issues, work with and harmonize demands from… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …individual provides expertise in cell culture, purification, freeze drying, formulation , powder processing, engineering, design, and scale-up. This role supports ... actions coming out of deviation investigations & CAPAs within our GMP manufacturing operations at our commercial pharmaceutical bioproduction plant. Relationships Reports to: Lead Engineer Number of subordinates with direct/indirect referral: None Essential… more
