- Merck & Co. (Rahway, NJ)
- …these programs are compliant and available to patients in markets as needed.-Primary Responsibilities: Lead a small team of CMC regulatory scientists ... include respiratory/ inhalation, peptide, antibody-drug conjugates (ADCs), and traditional solid-oral small molecules .- The Executive Director will help drive… more
- Merck & Co. (San Diego, CA)
- …targets in immunological disease through various modalities and approaches including small molecules , peptides, biologics, T cell engagers and others.Actively ... of immunology with a focus on autoimmune/inflammatory diseasesExperience in compound ( small molecules , biologics, other modalities) discovery and design for… more
- Merck & Co. (Rahway, NJ)
- … lead packaging development for new products including parenteral products including small molecules , biologics, vaccines and oral solid dosage. This role ... involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior exp erience… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead , Small Molecules (Associate Director), you will be responsible ... which are complex or span across multiple products. + Lead a small team within GMSci ...to perform the global reporting of process performance. + Lead multiple CMC teams with competing priorities.… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs, CMC Small Molecules where you will oversee the development and ... matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product… more
- Merck (Rahway, NJ)
- …are compliant and available to patients in markets as needed. **Primary Responsibilities:** + Lead a small team of CMC regulatory scientists responsible for ... include respiratory/ inhalation, peptide, antibody-drug conjugates (ADCs), and traditional solid-oral small molecules . The Executive Director will help drive our… more
- Takeda Pharmaceuticals (Boston, MA)
- …and post-approval activities at the site level. Supporting diverse modalities-including small molecules , biologics, and external manufacturing sites-the role ... regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. + Collaborate with external… more
- Lilly (Indianapolis, IN)
- …innovative technical solutions to advance an existing portfolio that includes small molecules , synthetic peptides, oligonucleotides, and other emerging ... isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials,...able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging… more
- Lilly (Indianapolis, IN)
- …innovative technical solutions to advance an existing portfolio that includes small molecules , synthetic peptides, oligonucleotides, and other emerging ... isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials...able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging… more
- Lilly (Indianapolis, IN)
- …position seeks a collaborative, inclusive, energetic leader who will define and lead activities with external synthetic CMC collaborations. This role will ... greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our portfolio of medicines is growing and is one… more
- Takeda Pharmaceuticals (Boston, MA)
- …Authorities. **How will you contribute:** + Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization ; may serves as ... projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities. + Develops and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …BMS's internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules , protein biotherapeutics, protein ... **Business Unit Summary:** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
- Gilead Sciences, Inc. (Foster City, CA)
- …implement new technologies to drive innovation in Formulation and Process Development for small molecules + Drive development and implementation of new systems ... small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization Provide technical, operational, and strategic guidance… more
- Astrix Technology (Minneapolis, MN)
- …and on-time client delivery. + Oversee small -scale synthesis and formulation of small molecules , peptides, and antibodies. + Prepare and manage CMC ... or related field. + 5+ years of experience in pharmaceutical/biotech product development ( small molecules , peptides, or antibodies). + Proven leadership in team… more
- Astrix Technology (Olmsted County, MN)
- …enhance small -scale synthesis and formulation processes for small molecules , peptides, and antibodies. + Manage CMC documentation to support regulatory ... of 5 years of experience in pharmaceutical/biotech product development involving small molecules , peptides, or antibodies. + Proven leadership experience,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Foster City, California. **Senior Director,** **Product Management** **Team** ** Lead ** **(Early Phase)** **_Location: Foster City_** **KEY RESPONSIBILITIES** ... Manufacturing (PDM) organization, the **Senior Director, Product Management Team Lead ** will lead a team of product...Strategy Team Leads to support a diverse portfolio of small molecule and biologics drug candidates across development and… more
- Lilly (Indianapolis, IN)
- …organization, focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal ... + Develop processes for use in clinical trial manufacturing. + Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA. + Build process capabilities for… more
- Merck (San Diego, CA)
- …of novel targets in immunological disease through various modalities and approaches including small molecules , peptides, biologics, T cell engagers and others. + ... of immunology with a focus on autoimmune/inflammatory diseases + Experience in compound ( small molecules , biologics, other modalities) discovery and design for a… more
- Catalent Pharma Solutions (San Diego, CA)
- …formulation technologies required. Experience with bioavailability enhancing techniques for oral small molecules is important. Current understanding of cGMP ... small molecule and peptide therapeutics. The Director will lead the PD team and work in tandem with...objectives. + Provide direction for the development of drug CMC efforts including toxicology and human studies. + Communicate… more
- Amgen (Thousand Oaks, CA)
- …Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. + May lead and develop a small group of scientists. **What we expect of ... programs. + Develop, optimize, and authorize analytical methods for synthetic molecules release testing and characterization + Collaborate closely with drug… more
