- Merck (North Wales, PA)
- … responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory ... guidelines regarding IND/BLAs or post approval changes. + The CMC Project Lead is accountable for the...and cross functional partners and provide recommendations to Regulatory CMC leadership team as appropriate. + Provide… more
- Lilly (Philadelphia, PA)
- …**Responsibilities:** + Responsible for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions ... people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the...for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for… more
- Merck (North Wales, PA)
- …Description:** ** Director , Project Management, Chemistry Manufacturing & Controls ( CMC )** Global Project and Alliance Management (GPAM) sits in the Research ... more junior staff in the nuances of managing a CMC project: management of team dynamics, understanding...recommend, contribute to development of conceptual plans for, and lead implementation of, strategic, process, and team … more
- J&J Family of Companies (Horsham, PA)
- …is responsible for. + Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally + Leads the ... Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position...+ Provides guidance and expertise to the Global Regulatory Team to develop global submission plans that comply with… more
- Lilly (Philadelphia, PA)
- …radiopharmaceutical products working in a fast-paced, multi-disciplinary environment. + Lead multidisciplinary cross functional team (s) to develop, manufacture, ... timelines, quality standards, and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC ...leadership, communication, interpersonal and negotiating skills. + Ability to lead a team of direct or matrixed… more
- Organon & Co. (Plymouth Meeting, PA)
- …coordinate with Regulatory CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure high ... **Job Description** **The Position** Reporting to the Director in Organon Regulatory Chemistry, Manufacturing and Controls...leadership, communication, interpersonal and negotiating skills. + Ability to lead a team of direct or matrixed… more
- Integra LifeSciences (Plainsboro, NJ)
- …to help improve outcomes. **SUMMARY** Under the direct supervision of the Director , Quality Reliability Microbiology, this individual will have a dotted line ... reporting structure to the local site quality leader . Responsibilities associated with this Sr. Microbiologist include interpreting microbiological testing data,… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible ... for the execution (in conjunction with the TMED Operations Lead ) and reporting thereof. The Director will...positive, transparent and inclusive approach as a representative or leader of cross-functional team (s). + Functional capability… more
- Merck (West Point, PA)
- …ultimately affects access, continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply Chain Working Group (SCWG) ... (GHH) brand/ franchise commercial goals. The Biologics VCM Product Leader (PL) serves as the primary end-to-end (E2E) supply...Group (SCWG) for pipeline products or Value Chain Management Team (VCMT) for commercial products + Lead … more
- Merck (West Point, PA)
- …ultimately affects access, continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply Chain Working Group (SCWG) ... brand/ franchise commercial goals. The Small Molecule VCM Product Leader (PL) serves as the primary end-to-end (E2E) supply...Group (SCWG) for pipeline products or Value Chain Management Team (VCMT) for commercial products. + Lead … more
- J&J Family of Companies (Titusville, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey or Pennsylvania. At Johnson & Johnson, ... Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health...and ensures strategy is in alignment with regional teams, CMC , commercial strategies, and the Target Product Profile +… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead ? This position is located in our ... CSL Behring is a global biotechnology leader , guided by a promise to save and...PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead , is… more
- Merck (West Point, PA)
- …performing teams, building talent, and shown to be able to motivate, influence scientific team ; lead by example through past scientific / technical expertise). + ... **Job Description** Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The… more
- Merck (Trenton, NJ)
- …international regulatory requirements. **Primary Responsibilities** : Leadership and Personnel Management + Lead and manage a high-performing team of quality and ... **Job Description** The Executive Director , Device Quality & Regulatory will play a...of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation and… more
- Merck (West Point, PA)
- …collaborative person to join the Research and Development Sciences (RaDS) value team responsible for enabling data and technology products and services that ... change the course of human health. As the technical leader of the Composition of Matter (COM) product line...Discovery and Development. You will direct a cross functional team to the successful realization of that vision, solving… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- Scientific Director - Upstream Process Development **Date:** Oct 28, 2024 **Location:** Philadelphia, PA, US, 19104 **Company:** Spark Therapeutics Join the Spark ... Team We were born of innovation, springing from the...product quality. He/she will be responsible to: + Matrix lead and provide guidance on efforts in platform improvement… more
- Actalent (Bridgewater, NJ)
- Job Title: Director Program Management Job Description The incumbent will lead a team of program management professionals, spearhead key organizational ... and latitude is expected. This position reports to the CEO. Responsibilities + Lead a team of program management professionals. + Independently manage and… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team , you will be part of building, leading ... and managing a team highly skilled medical doctors and guiding them in...part in developing the area as well as a lead role in various improvement projects, including process optimization.… more