- 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
- 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. (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
- Merck & Co. (Rahway, NJ)
- …for review and approval of documentation to support Good Manufacturing Practice ( GMP ) clinical supply drug product manufacture, testing, release and maintenance of ... and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution 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)
- …Partners (EPs). -This person will have the opportunity to participate and lead activities in all these areas. Responsibilities include: Work with External Partners ... activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications,… more
- Merck & Co. (Durham, NC)
- …data collection techniques, and troubleshooting in compliance with SDLC, GMP , safety, and environmental regulations.- Actively support, participate and embrace ... technologies and make a positive impact.- Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the… more
- Merck & Co. (Millsboro, DE)
- …of technical equipment and requires adherence to Good Manufacturing Practices ( GMP ) and Standard Operating Procedures (SOP). The associate specialist must have ... documentation, including charts, logbooks, and records.Participate in project teams and lead or support special projects.Provide training for LIMS and other… 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
- 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
- Merck & Co. (Rahway, NJ)
- …the Director of the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway supporting raw material, ... including supporting any lab investigations and deviationsReview and approval of GMP data, release specifications, analytical reports, Certificates of Analysis, and… 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)
- …products.-Position OverviewWe are seeking a highly skilled and motivated-Operations Team Lead -to oversee a dynamic team of 43 operations employees within our ... standards of safety, quality, and operational excellence.-Key ResponsibilitiesTeam Leadership: Lead , mentor, and develop a team of operations professionals,… more
- Merck & Co. (Durham, NC)
- …EnablonKnowledge of electrical maintenance and repair of electrical systems and equipmentActively lead the daily Tier 1 process and participate in the Tier 2 ... as needed for short-interval control boardCommunication:- Lead and support daily meetings to facilitate flow of information up/down through the organizationHold… more
- Aequor (Bothell, WA)
- …11pm rotating shifts and on weekendsTop Skills:Experience working in a GMP environmentExperience supporting end user Windows environmentComfortable working with AI ... Development Life Cycle, and Good Documentation PracticesComprehensive knowledge of SOPs, GMP , and other compliance requirements and regulatory guidelines (FDA, EU)… 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
- Merck & Co. (Durham, NC)
- …improve standard work based on learningsTrack industry trends and lead improvementsMonitor Quality Control and Assurance programsDevelop site logistics plans ... a high performing group of technical professionals.An understanding of GMP and regulatory qualification requirements and expectations are desirable.-Pharmaceutical… more
- ACROBiosystems Inc. (San Diego, CA)
- …our company goals and customer’s needs. The Field Application Scientist Manager/Director will lead the team of FAS to provide technical support to customers related ... to the ACROBiosystems product line. This individual will also primarily support our GMP product lines. In this position, you will be responsible for responding to… 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
