- ACROBiosystems Inc. (New York, NY)
- …discovery and validation, candidate drug screening and optimization, CMC development , preclinical and clinical studies, commercial production , and companion ... providing quality products and services and accelerating the process of therapeutic development . Our mission is to accelerate the process of target therapeutic drug… more
- Lundbeck (Bothell, WA)
- …cell line generation, MCB and WCB generation. Perform CHO cell line development processes including, transfection, cloning, characterization, and production in ... Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck … more
- GE Aerospace (Evendale, OH)
- **Job Description Summary** The Lead Ceramic Matrix Composite ( CMC ) Development Lab Engineer provides direction and assistance to the work group to achieve ... for aircraft engines and other aerospace applications. A successful Development Lab Engineer will operate both independently...successful CMC preform manufacturing in a low-rate production and lab environment + Lead and… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and rich ... capabilities to work collaboratively through all phases of CMC development with a primary focus on...robust, phase-appropriate cell culture processes for drug substance GMP production to enable human clinical studies and eventual licensure… more
- Bristol Myers Squibb (San Diego, CA)
- …novel pipeline. The radiopharmaceutical development scientist will assist with the CMC development plan and IND enabling activities, leading to clinical ... partners. + Support the set-up and on-going function of the radiochemistry laboratory to support translational development from pre-clinical to clinical… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a ... capabilities to work collaboratively through all phases of CMC development with a primary focus on...and molecular biology concepts. + Must enjoy a hands-on laboratory -focused role in a CMC multidisciplinary team… more
- AbbVie (South San Francisco, CA)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description Sr. Scientist I Cell/Molecular Biology The Development Sciences Biologics CMC Drug Substance Cell Line ... with synthetic biology screens + Familiarity with Chemistry, Manufacturing and Controls ( CMC ) and specifically CHO cell line development for GMP applications… more
- Catalent Pharma Solutions (Madison, WI)
- …BLA, or equivalent submissions; Author, review, and approve technical reports, process development summaries, and regulatory filing sections (eg, CMC ). + Serve ... **Director, Upstream Process Development ** **Position Summary** Catalent, Inc. is a leading...and tech transfer of processes for clinical and commercial production , meeting client expectations, regulatory requirements, and internal quality… more
- Cambrex High Point (Minneapolis, MN)
- …Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development ... and validate analytical testing methodologies used to control raw materials, production intermediates, and final products + Actively participate in teams assembled… more
- Lilly (Indianapolis, IN)
- …with other Lilly chemists, analytical chemists, bioconjugation scientists, biologics development team, engineers, CMC project management, Lilly manufacturing ... of how to safely manipulate highly-potent and/or cytotoxic compounds in a laboratory or production environment. + Familiarity with preparative scale… more
- Lundbeck (Bothell, WA)
- …line generation, MCB and WCB generation. + Perform CHO cell line development processes including, transfection, cloning, characterization, and production in ... Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …plans, lessons learned, standard methodologies + Participate and influence a cross-functional development team to advance production activities + Perform Viral ... This individual will be an integral leader of process development for the viral vector programs at Kite with...deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications, with a proven… more
- Astellas Pharma (Northbrook, IL)
- …exceptional value through industry leading management of the Astellas late-stage development and Commercial external supply network (CDMOs) across all product ... leader will be accountable for the following: Strategic Focus: + Development of external supplier strategic partnerships + Tiered governance and management… more
- Honeywell (Baton Rouge, LA)
- …Good Manufacturing Practice (GMP) guidelines + Reviews unexecuted and completed batch production and laboratory control records of critical process steps before ... (OOS/OOTs); follows up to verify effectiveness + Assists with development and implementation of cGMP compliant systems, including internal SOPs,… more
- Guidehouse (Bethesda, MD)
- …to troubleshoot and complete projects independently. * Experience leading cell line development projects for monoclonal antibody and/or vaccine production and ... monoclonal antibodies, recombinant proteins, and virus-like particles for preclinical development programs. * Provide continual support for generation and evaluation… more
- System One (Park Ridge, NJ)
- …and ensuring full regulatory compliance across the product lifecycle-from development through commercialization. This role will help enhance company position ... are essential. + Sterilization & Microbiological Expertise + Lead development , optimization, and validation of sterilization processes including ethylene oxide,… more
- MD Anderson Cancer Center (Houston, TX)
- …SPECIFIC COMPETENCIES** **Manufacturing Operations** * The most important function is the production of Radiopharmaceuticals that are safe and are of the highest ... agents for PET. * Contributes technical assistance and problem solving skills toward production problems that may arise. * Provides guidance and supervision to other… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance ... on the Floor activities including audit and release; handling of laboratory , deviation and complaint investigations; CAPA Creation and implementation; trending and… more
- RTX Corporation (Largo, FL)
- …depot and production programs at the Largo Consolidated Manufacturing Center ( CMC ). This role is primarily in support of the Air Traffic Navigation, Integration ... lab or manufacturing environment with standard EE lab / production equipment (ie, Vector Network Analyzers, Power...and maintenance employees, as they are essential to the development of our products. At Collins, the paths… more
- Kelly Services (Gaithersburg, MD)
- …generation of stable cell lines for preclinical and clinical material production to advance candidates including monoclonal antibodies, recombinant proteins, and ... top clone selection. + Draft and verify data for CMC sections of pre-IND and IND documents to ensure...perform, and troubleshoot experiments and analyze data for both development and deliverable projects. + Identify, propose, and execute… more
