- Merck & Co. (Rahway, NJ)
- …technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located at Rahway, ... or related discipline with at least 5 years of relevant pharmaceutical development experience or PhD in Analytical Chemistry or related discipline with… more
- Merck & Co. (Rahway, NJ)
- …tracking, and communicating regarding submissions and approvals to support continued product supply.Participate - in early and late development programs, ... with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager), and will provide both ... will be responsible for leading and developing QC - Chemistry scientists that support the ongoing development ,...new test methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, ... Chemistry , Biochemistry or related discipline Required Experience and Skills :Deep drug product development expertise with exposure to all stages and aspects… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... The incumbent will also have to demonstrate domain expertise in sterile product development and collaborate effectively with multiple stakeholders across both… more
- Merck & Co. (Rahway, NJ)
- …science with 10 years of industrial experience with pharmaceutical drug substance and/or product development .Ph.D. in chemistry or related science with 7 ... division.This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to… more
- Lundbeck (Bothell, WA)
- …Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development ... Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC… more
- Merck & Co. (Rahway, NJ)
- … and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of ... strategy that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent … more
- Merck & Co. (Rahway, NJ)
- …of scientists in solving complex analytical problems at the interface of biology, chemistry , and lab informatics disciplines to enable development of biologics ... and stability assays for testing of clinical trial material and in support of product and process development .A strong team player with excellent oral and… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of... of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation ... for regulatory filings.Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Merck & Co. (Rahway, NJ)
- …operations, and interface with cross-functional colleagues/customers in drug substance, drug product , and material science. Mentoring chemistry and engineering ... Job DescriptionThe Chemical Engineering Research & Development department (CERD), part of the Process Research...recognized expert in the field of crystallization and solid-state chemistry , this role offers the unique opportunity to influence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Responsibilities:Lead development of new, innovative approaches for product development , generation of experimental designs, execution ... while also helping to coach others in a collaborative environmentCoordinate development activities with process chemistry , material biopharmaceutics, analytical,… more
- Merck & Co. (Rahway, NJ)
- …strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product ... supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small… more
- Merck & Co. (Rahway, NJ)
- …role tasked with solving complex analytical problems at the interface of biology, chemistry , and lab informatics disciplines to enable development of Biologics ... and stability assays for testing of clinical trial material and in support of product and process development .A strong team player with excellent oral and… more
- Merck & Co. (Rahway, NJ)
- …current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, eg in a pilot and/or factory ... and tools for statistical design of experiments. This role involves hands-on wet chemistry experimentation at the laboratory bench and kilo lab scales in addition to… more
- AUROBINDO (Durham, NC)
- …group of companies with a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of ... to live in.Job OverviewA highly skilled scientist with a background in chemistry and experience in the pharmaceutical industry. Proficient in LC-MS/MS techniques for… more
- AUROBINDO (Dayton, OH)
- …group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of ... tests accurately. Qualifications - Skills & RequirementsFamiliarity with wet chemistry techniques.Experience in operating Empower software.Experience in handling instruments… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Summary:The Analytical Chemist I will provide analytical testing to support ongoing product release, raw material release and stability studies as needed, generate, ... and review technical documents that support raw material and product release and stability, will be responsible for managing activities with good time management to… more
