- Merck & Co. (Rahway, NJ)
- …lead Drug Substance working groups (DSWG) across the Biologics Commercialization portfolio Support CMC teams and align resources to deliver on program priorities ... risk assessments, control strategies, comparability reports, PPQ, and regulatory submissions Support and contribute to regulatory filings (IND, MAA, BLA) Prepare for… more
- Merck & Co. (Rahway, NJ)
- …formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities. - Coordinate ... role, the individual will be responsible for supporting the formulation development of new chemical entities as part of a matrix team from initial first in human… more
- Merck & Co. (Rahway, NJ)
- …agencies (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage ... engage with governance bodies. -Excellent interpersonal and communication skillsProject Management :-Drive project schedules, set clear priorities, and monitor performance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders.Summary: The qualified candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of ... Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management ) may also be required. Additionally, the candidate will also … more
- Merck & Co. (Rahway, NJ)
- …formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while also helping ... CMC project teams and the formulation development of new chemical entities through a matrix team from initial first...Mentors technical staff to develop team members scientifically and support the execution of pipeline programs - Ability to… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adaptability, Adaptability, Applied Engineering, Automation Systems, Business, Capital Project Management , Change Management , Chemical Manufacturing, ... Health and Safety, Global Mindset, Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Processes, Manufacturing Scale-Up, Manufacturing Support… more
- Merck & Co. (Rahway, NJ)
- …to drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline. Responsibilities: - Under the scientific ... and active pharmaceutical ingredients during "wet chemistry" operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical product development. -This individual will use innovative approaches to support both early and late stage development candidates including screening, ... development teams while interfacing with other functional areas (eg project management , manufacturing, quality, regulatory affairs) and external partners to drive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Scientists and Engineers support internal development and internal/external manufacturing operations to remain operational, continuously improve, ... Scientists have opportunities across many diverse areas including Biological, Chemical , Automation, Safety, Technical Services, Process Development, Analytical, Regulatory,… more
- Merck & Co. (Rahway, NJ)
- …and developing sterile products for injectables and ocular drug products. Support both early and late-stage development candidates that will include ensuring ... fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development… more
- Novo Nordisk Inc. (Durham, NC)
- …knowledge of database management systems preferred Expert in the area of chemical analysis of in-process, release, and stability testing required We commit to an ... for supervising QC activities and personnel within the Stability and Support Teams. Additional responsibilities includes ensuring testing of in-process, release, and… more
- Merck & Co. (Durham, NC)
- …that are study leads for processing steps.- The candidate must have demonstrated people management skills, as well as ability to support and mentor others on ... as part of the new product vaccine tech transfers to the facility.The Process Support Lab at the Durham site is seeking a Manager with outstanding interpersonal,… more
- Merck & Co. (Durham, NC)
- …Review, Batch Releases, Biological Sciences, Business Initiatives, cGMP Regulations, Change Management , Chemical Biology, Deviation Management , Good ... Job DescriptionPrimary Responsibilities: Support the company-Durham site and Quality organization by performing tasks associated with the site's goals and initiatives… more
- Aequor (Thousand Oaks, CA)
- …and Supervisory Control and Data Acquisition systems (SCADA). 2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit ... issues related to mechanical, electrical, instrumentation and control systems. 7) Support new product introductions or new technology introductions by performing… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife Pharma a jump ... solid pharmaceutical portfolio. The Aurolife family consists of an experienced management team with expertise in Manufacturing, R&D, Quality Assurance, Quality… more
- Merck & Co. (Rahway, NJ)
- …related to API development and commercial supply and provide critical analytical support to ensure the successful commercialization of API manufacturing processes. - ... Analytical Method Development, Bioanalysis, Biochemical Analysis, Biochemical Assays, Business, Chemical Proteomics, Chemical Synthesis, Chemistry, Chemometrics, Communication,… more
- Raytheon (Tucson, AZ)
- …including formulation and manufacture while also having excellent wet chemistry skills to support routine day to day analysis of materials used in the manufacture of ... our products. Chemistry problems in our laboratory involve performing chemical analysis on various materials (adhesives, polymers, tapes, composites, metals, and… more
- Merck & Co. (Rahway, NJ)
- …medical device or combination product commercialization, tech transfers, operations support , and materials/components- Proficiency in project management - ... combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled syringes,… more
- Merck & Co. (Rahway, NJ)
- …to enable the flexibility and speed of the company's pipeline. Support the formulation, process development, and scale-up activities, quality investigations ... and change management , and author GMP standard operating procedures and protocols...and author GMP standard operating procedures and protocols in support of facility operations.Education Minimum Requirement: Master's degree in… more
- Merck & Co. (Durham, NC)
- …Good Manufacturing Practices (GMP), In-Process Control (IPC), Maintenance Management , Maintenance Processes, Manufacturing Processes, Operations Support , ... years; currently Durham employs 1,000+ people.This position is in direct support of our Intermediate Adjuvant manufacturing process and Sterile Supply manufacturing… more
