- Merck & Co. (Durham, NC)
- …project start-up in Durham, North Carolina. -The facility includes end-to-end processing of drug substance , drug product, including biotech culture growth, ... but are not limited to: Lead production schedule across operations (eg media, drug substance , drug product, etc.). Interface with site planning and other IPT… more
- Merck & Co. (Rahway, NJ)
- …Lab facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new ... Lab is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject… more
- Merck & Co. (Rahway, NJ)
- …is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently ... plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial… more
- Merck & Co. (Rahway, NJ)
- …mechanistic understanding of the interplay between formulation composition, process and stability of drug substance and drug product to ensure robustness, as ... by developing and implementing biophysical and particle characterization tools for biotherapeutic drug products as well as mentoring other team members in delivering… more
- Aequor (New Brunswick, NJ)
- …digital and modeling space. They will collaborate closely with partners within PD such as drug substance , drug product and analytical functions as well as ... with business partners such as IT. This role will report to the Sr Director, Product Development Strategy. Responsibilities Collect and curate data from multiple sources including electronic notebooks, spreadsheets, slide decks, and instrument files Ensure… more
- Insmed Incorporated (San Diego, CA)
- …of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product stability testing.Strong technical writing, ... study initiation and sample pulls for cell banks, starting materials, intermediates, drug substances, and drug products.Manage reference standard and critical… more
- Merck & Co. (Rahway, NJ)
- …and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and a broad array of oral, sterile and combination ... science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global… more
- Merck & Co. (Rahway, NJ)
- …methods and specifications for drug products as well as drug substance downstream formulation considerationsThe candidate should have experience in ... In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position… more
- Merck & Co. (Durham, NC)
- …position is in direct support of our Sterile Supply manufacturing process for Bulk Drug Substance . Focused areas of responsibility include but are not limited to ... activities of: Component Assembly, GMP Autoclaves, Dry Heat Ovens, Parts Washers, and area cleaning. Responsibilities may include but are not limited to; Support operations production through start-up and commissioning and qualification through licensure and… more
- Insmed Incorporated (San Diego, CA)
- …data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product. Provides strong technical ... (Upstream cell culture, downstream processing, and buffer) as well as drug product.Experience leading and/or interacting with GMP manufacturing, process validation,… more
- Merck & Co. (South San Francisco, CA)
- …process chemistry, and analytical development, formulation, identification of process impurities, drug substance and product degradants, and characterization of ... new NMR methods, and prospectively impacting problems related to drug discovery, characterization, and developmentStrong knowledge of organic chemistry, biochemistry… more
- Merck & Co. (Rahway, NJ)
- …modalities.- In this role, you will build and apply predictive tools for drug substance (upstream, downstream, and conjugation) and drug product ... manufacturing unit operations using a variety of process-modeling tools.-As a potential candidate, you should have advanced graduate degree(s) in an engineering or closely-related scientific discipline, and industrially-relevant experience in process modeling… more
- Aequor (Thousand Oaks, CA)
- …JD. Must be local and within commutable distance of Thousand Oaks. Pre-Pivotal Drug Substance Technologies Organization is seeking a Process Development Contract ... Worker to join the Cell Line Development group at the headquarters campus located in Thousand Oaks, CA. The Cell Line Development group is responsible for developing production cell lines for 's large molecule pipeline. In this role, the candidate will be… more
- Merck & Co. (Durham, NC)
- …is in direct support of our Downstream Purification manufacturing process for Bulk Drug Substance . Focused areas of responsibility include but are not limited ... to activities of: Tangential Flow Filtration, Chromatography, Homogenization, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal, communication, and collaboration skills responsible… more
- Aequor (Thousand Oaks, CA)
- …assay execution related to stability and development. Analytical background in drug substance /product testing. Experience in small molecule (synthetics). ... knowledge of stability testing for those products. Familiar with ICH guidelines and GMP/GLP testing. Must hold a minimum of a BS in Biology/Chemistry or related field. This person will be interacting with outsourced partners and must have excellent… more
- Aequor (West Greenwich, RI)
- …This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality ... requirements and deviations. Responsibilities Include the Following: Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations. Ensure that facilities, equipment,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …batch documentation & document on the applicable checklist Request status assignment for Drug Substance (K6) Verify potency has been calculated & entered into ... SAP by production Facilitate batch release activities Collect batch documentation in systems to include SAP, LIMS, & MES & update data as required Monitor status of batch status inputs as follows & communicate obstacles on timely progress: Open Deviations with… more
- Merck & Co. (Durham, NC)
- …is in direct support of our Downstream Purification manufacturing process for Bulk Drug Substance . Focused areas of responsibility include but are not limited ... to activities of: Tangential Flow Filtration, Chromatography, Homogenization , Process Monitoring, Sampling , and area cleaning. - - - Responsibilities may include but are not limited to; - Support operations production through start-up and commissioning and… more
- Insmed Incorporated (San Diego, CA)
- …project and business strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance, and ... manufacturing teams.Exercise judgment in selecting methods, techniques, and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and status of projects by giving oral updates or internal… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and hands-on experience with amorphous solid dispersion development * Basic understanding of drug substance and drug product development * Experience with ... to improve physical and chemical property of active pharmaceutical ingredients and drug product intermediate. As an employee of Boehringer Ingelheim, you will… more
