- Merck & Co. (North Wales, PA)
- …Digital Operations of critical QMS processes, including Content Management and Digital Validation . The Digital Validation Product Analyst will provide ... close support for the Digital Validation Product . In this role, you will...and handle multiple tasks well, under pressure. Ability to lead and influence others outside of a direct reporting… more
- Merck & Co. (Rahway, NJ)
- …Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements. Lead the ... respect to device component manufacture and final assembly of biologic/drug product with device constituent part. Lead /support the development, implementation and… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead is responsible for the management ... of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs to the sites… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us ... manufacturing organizations (CMOs) Collaborate with QC to ensure successful method validation at contract labs/CMOs; support investigations and lead … more
- Aequor (Thousand Oaks, CA)
- …2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. ... Environmental Characterization reports) Approve planned incidents) Represent QA on NPI team) Lead investigations) Lead plant audits, participate in site audits)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation and evidence generation for a successful market ... will engage the clinical, Medical Affairs and commercial organization and drive the product evidence strategies to ensure an effective use of HEOR and RWE methods.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross functional groups to enable robust production, testing and release of product to patients. Key Responsibilities Leads, directs, coaches, and develops an ... clinical production and strategically prepares for commercial supply of a CAR-T product Manages, plans, coordinates, staffs, and prepares timely execution of daily… more
- Merck & Co. (Durham, NC)
- …for supporting the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to process improvements. - ... clerical functions necessary to allow proper accountability and traceability of product . - Maintains, inventories, and transports all required equipment, materials,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... stability assays for testing of clinical trial material and in support of product and process development.A strong team player with excellent oral and written… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... Promotion Testing) Completes routine equipment maintenance May support equipment calibration/ validation or method verification Participates in systematic problem solving… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... and support records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Our expectation is that the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead developing a culture whereby ... safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and peers. Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel. Independently makes appropriate and ... Experience directly supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to develop and set… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's… more
- Meta (Sunnyvale, CA)
- …technology introduction, factory readiness, product launch and post-launch testing. As a Product Validation Lead , you will require working closely with a ... detail oriented and insist on the highest standards. **Required Skills:** Product Validation Lead Responsibilities: 1. Organize validation efforts… more
- Ford Motor Company (Dearborn, MI)
- …for all phases of engineering and integration - design concept, production release, validation , product launch. + Lead full-service suppliers in engineering, ... you ready to change the way the world moves? Product Development uses design thinking & user experience methods...to Job 1 (J1). **What you'll do ** + Lead Design, Release, Validation , and Launch of… more
- Lilly (Durham, NC)
- …for the discrete manufacturing steps + Support and/or own the technical agenda for the product or validation process + Lead risk management activities as it ... manufacturing of RTP products, including implementation of the process control and validation strategy. The scope of the role includes device assembly and packaging… more
- Actalent (Miramar, FL)
- …each project * Assist engineering and quality in product improvement through validation of corrective actions. * Lead or support as directed on improvement ... development from conception through production start. He/she will lead product qualification test plan development, interpret...engineering and quality in product improvement through validation of corrective actions. * Lead or… more
