- System One (Warren, NJ)
- Job Title: Regulatory Project Manager CMC Location: Warren NJ (Hybrid) Compensation: $80 W2 Type: Contract Responsibilities Primary Responsibilities: + ... to support project objectives. + Develop and maintain detailed CMC project plans, including resource allocation, risk management, and timeline tracking. +… more
- BeiGene (Emeryville, CA)
- …and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality ... product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC is ... a portfolio of development projects and/or marketed products within GRA CMC & Devices Departments (Small Molecules Marketed, Small Molecules Development, Products,… more
- GE Aerospace (Evendale, OH)
- …data science, manufacturing, quality, and program management. You will serve as a project manager and technical mentor for a small team of mechanical ... This role is within the Commercial Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division....of own team to arrive at decisions. + Manage project plans and action plans for executing on component… more
- WuXi AppTec (Philadelphia, PA)
- …projects, ensuring timely and high-quality delivery. **Responsibilities** * Provide analytical CMC -related support for new working order signing at BD, participate ... environment, stability studies, quality comparability, reference standard etc. Ensure that project requirements meet the regulatory requirement of the target filing… more
- Kelly Services (Seattle, WA)
- Kelly is hiring for a ** Project Manager ** position with one of our clients in **Seattle, WA.** + Full time- W2 + Hybrid + 6 months contract (May be extended or ... converted) + $48/hr **Job Description:** The Project Manager is closely partnered with the...communication to team members and management. Examples include MS Project Server, ePlan, PSI CMC database, OnePager… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team AD representative or team lead). + Represent functional area on CMC project teams by communicating activities from designated functional area to ... or externally. + Identify and plan broader technical objectives ( project and scientific related) with input from manager...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- Integra LifeSciences (Plainsboro, NJ)
- …challenging what's possible and making headway to help improve outcomes. The ** Project Engineering Manager ** is responsible for the technical and administrative ... and expansions, and may range upwards of $10M possibly spanning years. The Project Engineering Manager is responsible for multidisciplinary project … more
- Stantec (San Francisco, CA)
- Mechanical Engineer - Project Manager - ( 2400017O ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design practice. ... to consistently produce project deliverables that meet project requirements, project manager and...Strong knowledge of applicable codes and standards, including CBC, CMC , NFPA, and ASHRAE, as well as LEED, green… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description We are currently hiring a Project Manager Stability Optimization to join an exciting project ... reports to the Regional QA Systems Lead. Manage a project to optimize AbbVie Operation's stability program with the...Type II) have been prepared and submitted by RA CMC team + The reduced testing based on primary… more
- Intra-Cellular Therapies, Inc (NJ)
- …optimization, and supervision of other manufacturing activities at CMOs. + Work within the CMC group and with internal and external project teams for timely ... and respect in all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation… more
- Stantec (San Diego, CA)
- …and industry experience to consistently produce project deliverables that meet project requirements and project manager and client expectations. Work ... plumbing. **Your Key Responsibilities** + With direction from a project manager and/or Professional Engineer, designs mechanical...design. + Knowledge of applicable codes and standards, including CMC , CPC, CFC, CBC, NFPA, and ASHRAE, as well… more
- Merck (North Wales, PA)
- **Job Description** The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company. **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or… more
- RTX Corporation (Carlsbad, CA)
- …Job Overview: Pratt & Whitney is seeking a highly motivated individual to lead the Project Engineering team at the CMC Center of Excellence in Carlsbad, CA. The ... Senior Manager , Project Engineering will lead a team of Project Engineers and together the group will manage all site projects including capital projects,… more
- Ascendis Pharma (Palo Alto, CA)
- …for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. ... all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global regulatory… more
- Publicis Groupe (New York, NY)
- …win big and win every day. PXP is looking for a talented Senior Talent Manager . **Job Description** PXP is looking for an in-house expert on talent contracts (both ... Business Management and Finance. **Key Responsibilities** + Participate in project scoping discussions, providing Producers and Client teams with... needs + Work with our 3rd party Signatory, CMC , to inform them about all upcoming SAG projects… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality, regulatory, project management, legal, sourcing, supply ... will be part of a team based in Watertown, MA and report to the manager of the drug product outsourcing group. The team collaborates with other Boston-based teams on… more
- Actalent (Lexington, MA)
- Job Description Join our dynamic team as a QC Manager to support external contract organization activities, ensuring all GMP QC testing needs are met efficiently. ... Provide crucial internal support to CMC Operations to aid in the development, manufacture, and...for 30-40 hours weekly to become acquainted with the project , followed by a potential reduction to 20 hours.… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Jun 14, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56073 **Who we are** ... of all regulatory activities on assigned projects and ensure that the project deadlines and performance standards for these projects are established and met.… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... in accordance with Rush policies and procedures. **Responsibilities:** * Appropriately manage project billing by ensuring costs are correctly billed and invoices are… more