- Eisai, Inc (Exton, PA)
- …support in the operation of equipment to support commercial manufacturing .Coordinate equipment maintenance, calibration, and validation with appropriate internal ... deviations.Assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.Interact cross-functionally with… more
- Eisai, Inc (Exton, PA)
- …biologics , several of which must be in a management position.Strong knowledge of biologics manufacturing and analytical methodology as well as ICH, cGMP, EMEA ... scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for the review and interpretation… more
- Aequor (Libertyville, IL)
- …is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. The MSAT Tech Writer: Compiles and ... root cause investigation Cross-functional collaboration with engineering and quality partners Biologics or cell therapy manufacturing Trained in Kepner Tregoe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …discipline: engineering, science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is ... marketed CAR-T product as part of a multi-site global manufacturing network. This individual is required to manage a...network. Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT. Experience in a cross functional… more
- Merck & Co. (Durham, NC)
- …and support assay qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.Lead in design, execution and data ... interpersonal and communication skills (written and oral).Experience in vaccine or biologics processing, including either lab- or manufacturing - scale support… more
- Merck & Co. (Rahway, NJ)
- …in biologics process development and process characterization to enable efficient tech transfer to manufacturing sites.Experience in modeling such as Monte ... a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product… more
- Careerbuilder-US (Oceanside, CA)
- …stability and administration * Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and ... vaccines, antibody drug conjugates, etc.). * Previous experience interfacing with biologics drug product manufacturing sites and providing technical support… more
- Merck & Co. (Rahway, NJ)
- …activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech ... Job DescriptionThe recently opened Rahway Biologics Development Center (BDC) is the new home...network, and outside vendors to onboard new technologies, facilitate tech transfer, and ensure efficient operations. Communication, organization, and… more
- Merck & Co. (Rahway, NJ)
- …of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial ... macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Specialist… more
- Cynet Systems Inc. (Libertyville, IL)
- The MSAT Tech Writer: Compiles and interprets manufacturing process data to identify possible failure modes. Learns complex cell biology concepts & applies them ... root cause investigation. Cross-functional collaboration with engineering and quality partners. Biologics or cell therapy manufacturing . Trained in Kepner Tregoe… more
- Merck & Co. (Rahway, NJ)
- …our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the ... (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.Experience with medical device development with understanding of… more
- Sunrise Systems Inc (Libertyville, IL)
- …is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector. The MSAT Tech Writer: Compiles and ... root cause investigation Cross-functional collaboration with engineering and quality partners Biologics or cell therapy manufacturing Trained in Kepner Tregoe… more
- Kelly Services (Lincoln, NE)
- **Title** : Principal Process Scientist - Biologics Manufacturing **Salary** : Commensurate with experience/negotiable **Location** : Lincoln, Nebraska (onsite) ... costs, and facilitate transfer of new products to our manufacturing sites. This role assures strategic alignment to site...Lead and/or support IQ, OQ and PQ including related tech transfer activities + Monitor the product portfolio for… more
- Charles River Laboratories (Memphis, TN)
- …or engineering or advanced degree (MS preferred), with at least 5 years of biologics manufacturing experience or equivalent cGMP experience is required + A ... fully supported. This role will also work closely with Tech Transfer and Manufacturing Leadership to assess...not limited to experience, skills, education and location. **About Biologics Testing Solutions** With more than 50 years of… more
- AbbVie (Worcester, MA)
- …Mentors engineering staff and serves as a technical leader for matters associated with biologics manufacturing and tech transfer. Leverages broader team to ... New Product Introduction (eNPI) process within our dynamic and innovative Biologics manufacturing facility. This includes conducting facility fit assessments,… more
- AbbVie (Irvine, CA)
- …are essential. Responsibilities: + Support late stage and commercial biologics manufacturing , technology transfer, process validation, investigations, ... The S&T Toxins group within Operations Science & Technology - Biologics organization supports manufacturing , process validation, regulatory submission, and… more
- Kelly Services (Barceloneta, PR)
- …transfer. * Must have experience in Tech Transfer and Process Support for biologics manufacturing . * Must have the ability and experience to author technical ... to respond. * Act as process SME for designated area of biologics manufacturing for the technical center. Interprets problems and either creates or modifies… more
- US Tech Solutions (Gaithersburg, MD)
- …of SAP Finance/Ops modules. Candidate must have experience in cost accounting and biologics manufacturing . Candite must have experience in working on Large ... complex SAP project implementations. Candidate needs to have Biologics experience and manufacturing . Desire candidate will need to have 10 years of experience in… more
- Editas Medicine (Waltham, MA)
- …for the specific education and experience listed above. + Experience supporting cGMP biologics manufacturing required. + A working knowledge of cGMP requirements ... highly motivated and experienced quality professional to support internal GMP manufacturing operations. This position will be responsible for Quality Operations… more
- Kelly Services (Foster City, CA)
- …stability and administration + Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and ... vaccines, antibody drug conjugates, etc.). + Previous experience interfacing with biologics drug product manufacturing sites and providing technical support… more
