- Merck & Co. (Rahway, NJ)
- …robust scientific methodology, we partner to deliver the next medical breakthrough. Biologics Process Research & Development (BPR&D) within our Research Laboratories ... and inclusive environment for all. Beyond process development for pipeline biologics , we innovate and build next generation biomanufacturing technologies. Examples… more
- Merck & Co. (Rahway, NJ)
- …scientific methodology, we partner to deliver the next medical breakthrough. Biologics Process Research & Development (BPR&D) within our company'sResearch ... and inclusive environment for all. Beyond process development for pipeline biologics , we innovate and build next generation biomanufacturing technologies. Examples… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for a Senior Scientist ... of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.- The successful candidate must function… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs).-We are looking for a team player… more
- Eisai, Inc (Raleigh, NC)
- …you. Essential Functions Provides technical and administrative management oversight for the Biologics division within Tech Ops for US based staff and operations. ... within and between Tech Ops and other EDCS units regarding biologics when appropriate.Personally responsible and accountable for one or more significant… more
- Merck & Co. (North Wales, PA)
- …Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations ... the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation… more
- Eisai, Inc (Raleigh, NC)
- …the drug development process.Significant experience with manufacturing operations, biologics , and aseptic manufacturing.Experience with highly automated parenteral ... manufacturing processes, including isolators, automated inspection, Manufacturing Execution Systems and electronic batch release.Competent in analyzing complex products, production, and testing issues.Demonstrated scientific problem-solving capabilities.Direct… more
- Merck & Co. (Rahway, NJ)
- …and commercial drug substance manufacturing processes for vaccines and biologics .-- BDSC supports second generation process development and various commercialization ... stage and commercial large molecule programs with a focus on biologics downstream processing, including multi-specific antibody therapeutics, among other complex … more
- Merck & Co. (Rahway, NJ)
- …and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of ... sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and… more
- Merck & Co. (San Diego, CA)
- …Research and Development Division in San Diego is a cross-functional team (Discovery Biologics , Immunology, and Data Science) with the goal to discover and develop ... innovative therapeutics in the field of Inflammation and Immunology. The Discovery Biologics Department is seeking a Senior Scientist with expertise in antibody… more
- Merck & Co. (Rahway, NJ)
- …pipeline and post-market commercial manufacturing processes for vaccines and biologics . CCFS supports various commercialization activities, second generation process ... late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics . For commercial programs, activities include site-to-site process transfers,… more
- Merck & Co. (San Diego, CA)
- …Research and Development Division in San Diego is a cross-functional team (Discovery Biologics , Immunology, and Data Science) with the goal to discover and develop ... novel, innovative therapeutics in the field of Inflammation and Immunology.The Discovery Biologics Department is seeking a Senior Scientist to drive biologics … more
- BioAgilytix (San Diego, CA)
- …Working knowledge of selling GMP CMC analytical development and testing services for biologics and cell and gene therapies is preferred.As the Director of Business ... of selling GMP CMC analytical development and testing services for biologics and cell and gene therapies.Experience selling full release method development,… more
- Merck & Co. (Rahway, NJ)
- …drug products.Primary ResponsibilitiesDesigning and developing sterile products for biologics , small molecule, peptide, and oligonucleotide drugs for injectable ... kinetics, Transport phenomenon, polymer chemistry, physical pharmacy is highly desirable. Biologics formulation design/process development, alternative processing approaches,-definition of critical… more
- Lundbeck (San Francisco, CA)
- …Minimum of 3+ years sales management experience in Pharmaceutical, Biopharmaceutical's, Biologics or related experience. Internal candidates must have a minimum of ... Migraine experience highly preferred Experience in neurology, pain management, and/or biologics Experience in both medical and specialty pharmacy benefit market with… more
- Merck & Co. (North Wales, PA)
- …advisory letters, enforcement letters and policy issues affecting the pharmaceutical/ biologics industry. Communicate significant changes in FDA perspective to ... regulatory reviewRequired Experience and Skills: Minimum of five years of pharmaceutical/ biologics industry or related experience with an emphasis in regulatory or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country ... with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorisation Applications (MAAs), and local country… more
- Merck & Co. (Rahway, NJ)
- …understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, ... clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings.Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities. Minimum education required: Ph.D.… more
- Merck & Co. (Rahway, NJ)
- …understanding of global regulatory expectations for small molecules and biologics , authoring regulatory documents (INDs, CSRs, CTDs)Required Experience:Ph.D. or ... equivalent degree with at least 7 years of experience OR a PharmD or equivalent degree with at least 9 years of experience OR an MS or equivalent degree with at least 11 years of experience, where "experience" means having a record of increasing responsibility… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center is a new 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 though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product… more
