- ProPharma Group (Western Springs, IL)
- …a subject matter lead for assigned areas of QA, regulatory and GMP compliance projects. Essential Functions Primary responsible for representing the company as a ... 3 years managing a technology business or business unit or CQA or GMP SME lead is preferred. We celebrate our differences and strive to create a workplace… more
- Merck & Co. (Rahway, NJ)
- …is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice ( GMP ) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile… more
- Merck & Co. (Durham, NC)
- …pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support ... Experience and Skills:Familiarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small-Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and ... gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for… more
- Insmed Incorporated (San Diego, CA)
- …play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and quality control operations. This ... leading the procurement, installation, and qualification of instruments and equipment for GMP manufacturing and quality control (QC), with the flexibility to support… more
- Merck & Co. (Durham, NC)
- …to focus instrument performance and minimize downtime.Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and develop ... appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records and ensure quality notifications follow when… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records ... change in the pursuit of continuous improvement.Support projects with the potential to lead projects for the site.Able to train individuals in the execution of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and ... gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for… more
- Merck & Co. (Durham, NC)
- …and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safetyTactical ... metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).-Continuous Improvement - Accountable for developing our Company… more
- Merck & Co. (Rahway, NJ)
- …and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating ... improvement opportunities, and develop unbiased tangible and intangible value realized.Understanding of GMP with a strong motivation to build deep expertise in CMC… more
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital ... team at ATO B20. The NPI Lead is expected to have ownership over the Technology...in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time… more
- Merck & Co. (Durham, NC)
- …and customer service-oriented leader to support the GBF IPT. Will lead the tactical and strategic equipment reliability improvements, calibrations, human resources ... execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdownsCoordinates activities with… more
- Repligen (Rancho Dominguez, CA)
- …are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at ... Filtration (TFF) systems, process engineering, and equipment qualification, preferably within GMP or ISO 9001 environments. Success in this role requires technical… more
- Merck & Co. (Durham, NC)
- …advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with site commercialization efforts ... implementation and close-out to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Aequor (Houston, TX)
- …Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records) o Problem solving in a ... Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records) Computer Skills Proficient in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Oncology Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary.This position is ... Research QA, PV QA, CSPV and other internal QA stakeholders such as GMP QA, specifically for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …current Provide constructive and timely feedback towards performance expectations and goals Lead site training program Develop, coach, and build competencies of the ... of best practices to/from other M2-US or NN teams Lead document control process across site Design & own...to use &/or update relational databases required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement… more
- Merck & Co. (Durham, NC)
- …to advance project goals and deliverables related to the vaccine process Lead technical studies , projects and author documentation associated with site ... implementation and close-out to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical… more
