- Merck (Rahway, NJ)
- …Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . The Associate Director operates under the ... and Safety), Engineering Firms and Vendors to progress deliverables. The Associate Director would be responsible for leading planning, design, and implementation… more
- BeiGene (Hopewell, NJ)
- **_General Description:_** The Associate Director Site Technical Services is responsible for the day-to-day activities of the Validation team, Metrology, ... compliance and achieving commercial success. Reviews, authors and works with CQV validation of start-up Green-Field Project. Works with Drug substance, Drug Product,… more
- Sumitomo Pharma (Trenton, NJ)
- ** Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical ... highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who...+ Partners with CMC to conduct method transfers and validation of new or existing analytical methods for release… more
- Amicus Therapeutics (Princeton, NJ)
- Associate Director , Clinical Data Management Location Princeton, NJ Requisition ID 2245 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1289) Associate Director , Clinical Data Management Amicus Therapeutics is… more
- Lilly (Branchburg, NJ)
- …Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives. The JPT Associate Director is the key business relationship owner and is ... materials are delivered on time and within downstream customer expectations. The JPT Associate Director will partner with Lilly's Process Research & Development… more
- Bristol Myers Squibb (Princeton, NJ)
- …pharmaceutical industry for the Sr. Research Investigator level or 5+ years for the Associate Director level. No additional industry experience is needed for the ... $121,000 - $167,2000, plus incentive cash and stock opportunities (based on eligibility). ** Associate Director :** the starting compensation for this job is a… more
- Bristol Myers Squibb (Princeton, NJ)
- …future therapeutics. Reporting to Senior Scientific Director Translational Medicine, the TM Associate Director will be part of the late stage TM group. The ... biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable + Manages… more
- Bristol Myers Squibb (Summit, NJ)
- …. **Position Title:** IT Site Shared Services & Lab Systems Lead, Associate Director **Location:** Summit West, S12 **PURPOSE AND SCOPE OF ... and IT Life Cycle Management (LCM). + Understanding of computer system validation . **Education and Experience:** + Bachelor's degree in an engineering or MIS… more
- Axtria, Inc. (Berkeley Heights, NJ)
- …organization with an employee-first philosophy that promotes self-growth. The Role As an Associate Director within Axtria's Data Science COE you will have the ... + Validate and refine models using various evaluation techniques, including cross- validation , hypothesis testing, and performance metrics. + Interpret model results… more
- System One (Basking Ridge, NJ)
- Job Title: Associate Director , Biostatistics Client - Global Pharmaceutical Company Location: Remote, US Based only - must reside in EST or CST time zones Type: ... CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main… more
- Bristol Myers Squibb (Summit, NJ)
- …cGMP standards including extensive knowledge of regulatory guidelines and validation practices + Working knowledge of pharmaceutical development and ... commercialization processes. + Knowledge of suppliers, industry trends and emerging players in global pharmaceutical manufacturing services + Strong presentation and communication skills both, oral and written - Fluency in English. _Required competencies:_ +… 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 ... statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. - Drug Development Strategy: Provides input to multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …established standard processes to facilitate alignment of technology transfer and validation activities across the projects for (mAb, Drug Substance, Drug Product, ... or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a smooth transition of projects, recommends, and implements new technologies, as needed and supports Supply Chain Management with… more
- BeiGene (Hopewell, NJ)
- …Expertise in equipment identification/procurement as well as DQ, IOQ and Validation activities. + Expertise with chromatography systems (AKTA), tangential flow ... filtration, analytical equipment. + Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools. + Experience with downstream process design, optimization, and tech transfer to… 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 ... statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. + Drug Development Strategy: Provides input to multiple… more
- Merck (Rahway, NJ)
- …of the RY880 building. The sterile portion of RY880 is in commissioning/qualification/ validation . Successfully delivering on the entire scope of FLEx, including the ... qualification and validation work in the RY880 sterile modality, is a...is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the ... not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies… more
- TD Bank (Mount Laurel, NJ)
- …of Business:** Risk Management **Job Description:** The Regulatory Relationship Associate provides strategic oversight, assistance, and relationship management with ... Support audit teams for regulatory matters. + Contribute to Board of Director reporting and Audit Practices updates + Participate in relevant initiatives/projects. +… more
- Trustmark (Trenton, NJ)
- …will be a member of Information Security Team reporting to the Executive Director of Cybersecurity. This individual will also have a dotted line reporting ... and access only. * Recommend Information Security control tests that will provide validation that the appropriate controls are in place. * Assist in quantifiable… more
- Wolters Kluwer (Trenton, NJ)
- …optimal care for patients. In this remote-friendly position, you will report to the Associate Director of Clinical Content within the Health division of Wolters ... data outcomes. Understand the needs and expectations of the assessment and validation of client problem. Ensure quality responses (written, verbal) to customer… more