covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Job Scope... is $85,000 - $125,000, based on experience level. Key Responsibilities: Lead NPI project with linear solution for Antibody Expression...
Regulatory Affairs, CMC, Clinical, and Quality-to support regulatory strategy and execution across development programs. Key... Responsibilities Submission Planning & Management Lead the end-to-end planning, coordination, and execution of global regulatory...
scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed... with Clinical Operations, CMC, Quality, Regulatory, Finance, and external vendors. Reporting to the Senior Director, Clinical Supply...
Development teams, etc), CMC PM, Medical Affairs PM, Launch PM) to ensure seamless PPM support across molecules Ensure effective..., performance reviews), maintaining strong functional dynamics, acting as function lead or representative for enterprise-wide...
it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads... they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills...
that will fundamentally and forever change the life sciences industry. What You Will Do Lead a team of Scientific Business Analysts... accounts Lead by example and coach your team to develop in their careers and inspire your team to do the best work...
Development, Late-Stage Development/CMC, Manufacturing/QC 3+ years in management consulting Worked in startup environments Led... targets. Lead key account delivery teams consisting of project managers, scientific data architects, scientific business...
discovery (target ID through lead optimization), preclinical development, CMC (all drug modalities), or product quality testing...
on , , , , and . Job Description Purpose: The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead..., from phase II clinical through commercial. Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T...
it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads... they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills...
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant... with regulatory expectations, and partner cross-functionally to support process development, formulation, CMC, and quality activities...
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant... with regulatory expectations, and partner cross-functionally to support process development, formulation, CMC, and quality activities...
lead and grow our research engine. You’ll work shoulder-to-shoulder with technical leadership and a team of fellow..., coordinating, and supporting the research efforts across multiple collaborative research programs Contribute to, and lead...
) for a comprehensive understanding of the product structure-function relationship. Lead CMC analytical development with in-depth knowledge... goals, while actively creating development opportunities to motivate and support a high-performing team. Lead CQA...
Brand Team, CMC, Integrated evidence strategy team, Value and Access team, Regulatory strategy, etc.). Ensure... of experience across multiple assets is also acceptable. Demonstrated ability to lead. motivate and elicit top performance...
production. The Opportunity: As a Principal Process Engineer, you lead and support various aspects of the design, and startup... as authoring technical assessments. Additionally, you will: Lead End-to-End Technology Transfer: Drive the seamless transition...
Job Description We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition... & leadership: Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials...
appropriate product specification as part of product control strategy creation; collaborate with CMC Lead to establish a phase... decisions and serving as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality...
, and the Food Drug and Cosmetic Act) the company’s Research, Development, Clinical, Regulatory, Manufacturing/CMC, Medical... management. variety of activities such as licensing and research collaborations, pre-clinical and clinical matters, CMC (supply...
~ 3 days per week in the office location Introduction to role Are you ready to lead the charge in transforming... be at the forefront of change, driving platform establishment across the enterprise! The GTO Platform Lead represents...