- Insmed Incorporated (NJ)
- …successful and timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both ... in. Are you?About the Role:Reporting to the Director of Technical Operations , Project Management this position will be responsible for leading life-cycle… more
- Merck & Co. (Rahway, NJ)
- …data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be ... with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on...the value that digital solutions can bring to our operations is desirable.The responsibilities of the -include: Project … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition OverviewThe Project Manager, Patient Engagement works closely with the Scientific Patient Engagement & Advocacy Lead and is responsible ... or life sciences setting. The candidate must be able to plan, lead , and facilitate the execution of patient engagement activities within a cross-functional… more
- Aequor (Thousand Oaks, CA)
- …May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation ... Project Planning meetings, Variation Execution Meetings and/or Regional Operations Team meetings Establish effective relationships with key stakeholders across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that fit the site's needs. The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project delivery.Leads ... Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support… more
- Formation Bio (New York, NY)
- …to high standards of quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in as the ... or a related field. Minimum of 10 years of clinical project management/clinical operations experience, including at least 5 years in a leadership capacity.… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Syner-G BioPharma Group (Boston, MA)
- …list is not exhaustive and may be supplemented and changed as necessary.) Lead and manage facilities operations , including preventive and corrective maintenance ... projects. We provide strategic guidance and hands-on expertise to streamline operations , enhance quality systems, and ensure regulatory compliance, empowering our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory ... FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs… more
- Merck & Co. (Durham, NC)
- …smaller improvement projects in their operational area- Represent Operations on project teams as needed- - Communication- Lead and support daily (Tier) ... night shift positions, 12.5 hour rotation (2-2-3). - - The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Operational Study Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- - Lead the core study team while project managing and ... level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies- Lead escalation and resolution of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Process Trainer, Aseptic Process as part of the Technical Operations ... Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy… more
- Genmab (NJ)
- …Then we would love to have you join us!Overview:The Director, Feasibility Lead , will drive the implementation of strategic, data-driven feasibility practices that ... mentoring team members, and contributing to cross-functional strategies.The Director will lead complex feasibility initiatives and serve as a senior subject matter… more
- Insmed Incorporated (NJ)
- …other third-party providers in alignment with clinical development and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead ... we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio status ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...an SDL is not available. The Director may represent operations as needed/required at GPT and meet with stakeholders… more
- Merck & Co. (Rahway, NJ)
- …microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations .- The primary objective of the position is to oversee GMP environmental ... and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include… more
- Cipla (Hauppauge, NY)
- …outside of Cipla's US Subsidiaries or Affiliates. Job Title Operations Investigator (Manufacturing and Packaging) Organization Name InvaGen Pharmaceuticals, Inc. ... prevent recurrence. Work with cross-functional teams to gather data, lead , and perform Root Cause Analysis to determine the...Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the… more
- Cipla (Fall River, MA)
- …of all the equipment and associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup for shop floor QA Associates. ... Complete other duties or participate in project work as assigned by management. Education and Experience...believes that our biggest assets are the employees who lead us to prosperity and growth in the future.… more
- Merck & Co. (Rahway, NJ)
- …policy, communications, medical affairs, and PI&ELead the team's engagement with Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ... Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides...and compassionate and leads directly and through influence. They lead the regional Patient Innovation & Engagement (PI&E) team… more
- ValSource, Inc. (Worcester, MA)
- … Lead cross-functional teams across engineering, quality, validation, and operations . Collaborate with Jacobs project teams and internal stakeholders ... to act in the best interest of the client. Lead the project through an offsite design...working knowledge of GMP systems, equipment qualification, and process operations . Proven ability to lead teams, manage… more
