- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title cGMP Operations and Clinical Projects Associate Job Profile Title Research Coordinator ... (GMP) guidance and Good Laboratory Practice (GLP) compliance. The cGMP Operations and Clinical Projects Associate will serve as a liaison across multiple… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Specialist you must have a BS/BA and 2 years of related experience in cGMP manufacturing operations ( clinical and/or commercial External Manufacturing) or ... subject matter expert for Oracle to process CMO Quotes ( Project Plans/Work Orders) and invoices, tracking the status of...a BS/BA and 5 years of related experience in cGMP manufacturing operations ( clinical and/or… more
- University of Southern California (Los Angeles, CA)
- …in technology transfer of manufacturing processes from pre- clinical into cGMP environment. + Provides verification of facility operations and equipment, ... Practice ( cGMP ) principles. Job Accountabilities: + Supports cGMP manufacturing operations with responsibility for quality...as needed. Supervises and directs junior staff to achieve project goals. Serves as a resource to cGMP… more
- Colorado State University (Fort Collins, CO)
- …overall organization, operational and project leadership in support of cGMP biopharma campaigns to produce early phase clinical material. Responsibilities ... ( CDMO ) of cGMP compliant material for use in early phase clinical trials. It was was created to translate and produce biopharmaceutical products for non-… more
- Catalent Pharma Solutions (Harmans, MD)
- …future manufacturing operations ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines + ... **Manager, Manufacturing Technical Operations (MTO)** **Summary:** _Catalent, Inc. is a leading...and clients through proactive communication and accountability for on-time project /work completion; Interacts with clients on projects … more
- CBRE (Guaynabo, PR)
- …Sciences clients in Puerto Rico. We are currently seeking bilingual (Spanish/English) Project Managers with cGMP experience.** **About the role** The purpose ... Life Sciences Project Manager Talent Community Job ID 221941 Posted...lead. Experience working with medical imaging, vivarium, clean rooms, cGMP , pharmaceutical, sustainability initiatives, and biotech R&D facilities/ operations… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Senior Manager, Operations Quality Assurance, RayzeBio is responsible for the cGMP /GDP activities at CDMOs and at the Indianapolis site in accordance with ... supervisor responsibilities for up to 8 direct reports. The Operations Quality Assurance team is responsible for Quality collaboration...to the staff regarding the handling and resolution of cGMP events which may be a part of deviations,… more
- BioBridge Global (Norcross, GA)
- …tools and equipment. Must be able to use computer software to support lab operations in a cGMP environment. Must be capable of performing, evaluating, and ... pm with occasional on-call events FLSA: Exempt Hybrid? N Dept.: Biomedical Operations Business Unit: BioBridge Global CPF Level: P4 **General Summary** The incumbent… more
- Bristol Myers Squibb (Warren, NJ)
- …blood derived cell therapies per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment of a multi-product clinical facility under the ... is a member of the Cell Therapy Development and Operations (CTDO) organization. This position is for one of...aseptic processing or lab technique + General knowledge of cGMP /FDA regulated industry + Basic mathematical skills + General… more
- Charles River Laboratories (Rockville, MD)
- …Development and Operations organizations and the customer. The Senior CMC Project Manager manages multiple projects , either within one technology or within ... . Holistically plans all projects at any stage through mapping resource across projects . In this role, the Senior CMC Project Manager is the key interface… more
- Catalent Pharma Solutions (Greenville, NC)
- …compliance, and to the safety of every patient, consumer and Catalent employee. The Project Engineer I will assure projects are executed in accordance with ... ** Project Engineer I** **Position Summary** Catalent's Greenville, NC...current site methodologies, policies, industry best practices, and cGMP requirements. The role will leverage the knowledge of… more
- Catalent Pharma Solutions (Harmans, MD)
- …will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at ... life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the… more
- Bristol Myers Squibb (Summit, NJ)
- …and Accountabilities:** + Maintain continuity of current Good Manufacturing Procedures ( cGMP ) Direct material supply for manufacturing operations as well ... a high level of customer service. + Support implementation of key Indirect projects /policies at site and project manage the executional element of activity.… more
- Catalent Pharma Solutions (Harmans, MD)
- …in pharmaceutical or medical device testing, manufacturing, quality, project management, business management, business development, commercial operations ... **Manager, Commercial Operations ** Catalent Cell and Gene Therapy is looking...hard-to-express recombinant proteins and oncolytic viruses. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on… more
- BeOne Medicines (Cambridge, MA)
- … Study Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations , Regulatory, Quality, CMC). + Work with Clinical ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Sr. Manager, Clinical Supply Chain in Cambridge, MA: **Job Duties:** +...and develop risk mitigation plans. + Lead cross functional projects and process improvements related to drug supply. +… more
- Lilly (Lebanon, IN)
- …develop and implement the necessary systems and business processes required to support cGMP operations , and build the site culture. This will require significant ... and start-up the facility which is responsible for both clinical and commercial supply. **Position Brand Description:** We are...operations within the building + Know and follow cGMP practices, safe work habits, plant dress code, hygiene… more
- Catalent Pharma Solutions (Harmans, MD)
- …Technical Operations Specialist III** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the ... and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse._ _The… more
- Catalent Pharma Solutions (Malvern, PA)
- …services lead, this role serves as the CMTI lead client development projects , collaborates to prioritize work, communicates project status and effectively ... CMTI capabilities. Serve a focal point for client development projects , prioritizing work, communicating project status, and...policies. + Ensure adherence to CMTI Quality systems and cGMP standards. Manage project and client expectations… more
- Lilly (Indianapolis, IN)
- …Description:** This position is responsible for the overall supervision of manufacturing operations for the commercial and clinical production of radioligand ... Director Operations is directly responsible for managing the manufacturing operations function and ensuring it has the necessary capacity, capability and… more
- Catalent Pharma Solutions (Harmans, MD)
- …The **Engineer II, Manufacturing, Sciences, and Technology (MS&T)** will support GMP manufacturing operations as a project leader in the successful transfer and ... and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on...startup of clinical drug substance and drug product. The Engineer II… more