- Syner-G BioPharma Group (Boston, MA)
- …with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer .Experience with Fillers, Wave Bioreactor, Cell Processing ... processes for (re)qualification/(re)verification.Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …engagement through all phases of the product lifecycle: Early Development, Tech Transfer , Process Performance Qualification (PPQ) through Commercialization. Our ... regulatory compliance/requirements of manufacturing clinical and commercialization products. Support Tech Transfer of Biologics Manufacturing processes within… more
- Lilly (Lebanon, IN)
- …Foundry cGMP Operations; leverage deep process understanding to guide successful tech transfer , ensure right-first-time execution and reliable clinical supply. ... development, review, and alignment of critical technical documentation required for tech transfer . Lead and support facility fit assessments, risk analyses to… more
- Merck & Co. (Rahway, NJ)
- …technologies for pharmaceutical products.- Demonstrated depth in commercialization and tech transfer , assembly and packaging process improvement and ... including technical guidance to component or process changes, supporting tech transfers and investigations.- Develop and maintain key performance indicators… more
- Merck & Co. (Rahway, NJ)
- …including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial ... supply chain to-achieve uninterrupted long-term supplyLead DCT.- Critically assesses all team deliverables & fosters a learning and collaborative environment. -Prioritizes, interrogates and mitigates risks across all factors that may impact technical,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation.Assist in the development of ... process, operational, and quality improvements for manufacturing.Assist in the review and development of process-related protocols and documentation.Provide technical quality oversight for electronic batch records.Support manufacturing and technical operations… more
- Twist BioScience (South San Francisco, CA)
- …and coordinates activities across multiple functional groups including PMO, R&D, tech transfer , manufacturing, and QC/QA.Provides strategic guidance to ... cross-functional teams, and while managing multiple projects in parallel. Organize sprints, daily stand-ups, and retrospective meetings, and additional meetings to assist the project teamsAssist with coordinating user story grooming, sprint planning and… more
- Cipla (Hauppauge, NY)
- …follow-up with purchase for timely delivery Provide status of new products material to tech transfer during new product meetings Monitor the store operations for ... compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness : Ensure proper receipt, verification, segregation, storage, labelling and accounting of Packing Materials Monitor material is stored as per proper storage… more
- Cipla (Fall River, MA)
- …follow-up with purchase for timely delivery Provide status of new products material to tech transfer during new product meetings Monitor the store operations for ... compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper receipt, verification, segregation, storage, labelling and accounting of Packing Materials Monitor material is stored as per proper storage… more
- Cipla (Hauppauge, NY)
- …follow-up with purchase for timely delivery Provide status of new products material to tech transfer during new product meetings Monitor the store operations for ... compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness Ensure proper receipt, verification, segregation, storage, labelling and accounting of Packing Materials Monitor material is stored as per proper storage… more
