- Novo Nordisk Inc. (Boulder, CO)
- …drug product team that is responsible for ensuring clinical supply using aseptic manufacturing Identify and work with formulation development CROs to implement ... limited to formulation, sterilization, filling, and lyophilization Responsible for key manufacturing metrics / goals, support critical program milestones, and… more
- Cipla (Central Islip, NY)
- …Responsibilities/ Accountabilities Organize and oversee the activities related to the manufacturing of tablets and capsules to include delivery, in-process samples ... documents generated during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform SAP entry during and finish batches… more
- AUROBINDO (Durham, NC)
- …of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing . Aurolife has a 10 year history of extraordinary ... improved performance in: quality, cost, delivery, safety and morale.Takes an active leadership role in development and implementation of continuous process… more
- Insmed Incorporated (NJ)
- …external partners (CDMO, CMOs).What You'll Do: As the Vice President, Product Development - Chemistry, Manufacturing , and Controls (CMC), Small Molecules, you ... the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to help us expand what's possible for patients… more
- Insmed Incorporated (NJ)
- …organization.Additionally, you will collaborate with external stakeholders including Contract Development and Manufacturing Organizations (CDMOs) and raw ... understanding of vector biology (AAV, etc.), CMC requirements, and manufacturing for gene therapy.Strong leadership , communication, and organizational… more
- Merck & Co. (Rahway, NJ)
- Job Description Associate Principal Scientist, Biologics Analytical Research & Development Our Research Scientists are our Inventors. We identify and target steps in ... to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Research & Development Division is seeking… more
- Merck & Co. (Rahway, NJ)
- …will be expected to apply his/her knowledge of product design and development ; manufacturing process development , qualification, and validation; and ... program -specific design controls process and design history file development .Stay current with new device technologies, relevant worldwide regulations, standards,… more
- Merck & Co. (Rahway, NJ)
- …and Responsibilities: Program Leadership and Technical Project Management:Provide program leadership in the development , commercialization, and ... and Technology Organization. Thisposition is responsible for providing strategic program leadership , technical expertise, and project management in the… more
- Merck & Co. (Rahway, NJ)
- …align multi-year strategy with executive priorities, and partner closely with manufacturing leadership , engineering, and operations to deliver capabilities that ... Act as the senior product leader and primary point of contact for manufacturing leadership , engineering, commercial teams, supply chain, quality, IT, and… more
- Merck & Co. (North Wales, PA)
- …assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing , and marketing of medical drugs… more
- Syner-G BioPharma Group (Boston, MA)
- …our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership , and innovation. At Syner-G, we ... manufacturing requirements.Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of … more
- Merck & Co. (Rahway, NJ)
- …assurance, analytical laboratories, manufacturing , production support area, clinical development .-Strong leadership skills with the ability to lead teams ... and our company's standards and communicate project status to management.Act as Development Quality representative for in-house or outsourced manufacturing for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the design and implementation of new system updates for cell therapy development and manufacturing .When necessary, support coordination of studies related to ... is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role OverviewThe MES...be responsible for providing project management support to the development and administration of EBR and digital solutions at… more
- Cipla (Fall River, MA)
- …ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating ... include but are not limited to the following: Review of batch manufacturing /packaging records. Release of raw materials, packaging materials and finished products… more
- Merck & Co. (Rahway, NJ)
- …Additionally, this position will require applying knowledge in drug and device product development , such as manufacturing process development and validation, ... (or an equivalent field) + 3 years of combination product development experience. Leadership experience of combination product design verification programs… more
- Cipla (Hauppauge, NY)
- …and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications. Verification of raw ... Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging… more
- Novo Nordisk Inc. (Boulder, CO)
- …and operational readiness initiatives required to support clinical API internal manufacturing . Coordinate with leadership team & other relevant stakeholders ... requirements in accordance with Novo Nordisk Way Provide expertise on Good Manufacturing Practice compliance Ensure technical training & development on Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functions and sites.Support the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing .Support Legend's regulatory ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
- Merck & Co. (North Wales, PA)
- …of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing , and marketing of medical drugs… more
- Cipla (Fall River, MA)
- …Scope : Supervisor, Maintenance and Engineering conducts and directs sections of manufacturing process development projects and assists in performing more ... complex engineering projects to evaluate, select, and adapt standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant… more
