- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...relationships through active partnering with key internal (GRA, GRA CMC , Pharmaceutical Sciences , GMS, GQ etc.) and… more
- Actalent (Boston, MA)
- Position: Director /Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory professional to ... join our collaborative team as the Director /Sr. Director of Regulatory CMC ....Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies… more
- AbbVie (Boston, MA)
- …improvements, and drug substance tech transfers. Responsibilities: + Lead cross-functional CMC team(s) in authoring sections of regulatory documents, including INDs ... management. + Drive alignment with key business stakeholders including Development Sciences , Quality Assurance, Regulatory Affairs and others at the Director… more
- Actalent (Boston, MA)
- Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg CMC Teams, Program ... the US, EU and ROW including the preparation of CMC content of initial INDs/CTAs and amendments, GMO applications,...Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS in ... more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable for both ... / R&D and the commercial organizations + The Sr. Director , PS Portfolio Leader is a member of the...affairs + Has knowledge of fundamental understanding in Clinical Sciences , Regulatory CMC , DMPK, Pharmacology and Toxicology… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and life cycle management with a focus on Material Sciences (including biocompatibility, extractables and leachables, material attributes, etc.), ensuring ... and right first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Material Sciences ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + ... + Develop, implement and execute a smart sourcing strategy + Lead global CMC key initiatives and represent Pharmaceutical Science to other cross functional… more
- Sanofi Group (Cambridge, MA)
- …an **Analytical Development Director ** to lead the analytical group in our CMC function at Cambridge Crossing site, which is part of the synthetic platform ... **Job Title:** Analytical Development Director + **Location:** Cambridge, MA **About the Job**...company with one purpose: to chase the miracles of science to improve people's lives. We're also a company… more
- Sanofi Group (Waltham, MA)
- …state-of-the-art statistical designs and analysis expertise to clinical assays development and CMC analytical science while enjoying lots of opportunities to ... **Job title: Director Non-clinical Biostatistics - Vaccines** + Location: Swiftwater,...and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight ... + Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …and scientists in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual will ... drive team objectives and manage team performance in line with Pharmaceutical Sciences ' strategy to deliver on program strategy and initiatives. The individual is… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, WA, Devens, MA ... here at BMS with our Cell Therapy team. T he **Sr Manager/Associate Director - Sterility Assurance, Cell therapy technical Operations** reports to the Director… more
- Takeda Pharmaceuticals (Boston, MA)
- …GPT cross-functional sub-teams, such as the Clinical Subteam, Commercial Subteam, Pharmaceutical Sciences ( CMC ) Subteam, etc. to the GPT through function-based ... empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office....Planning and Execution** + Oversees and leads all clinical science activities involved in interactions with FDA and other… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Senior Manager/Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve human ... including DMPK, translational medicine, clinical development, clinical operations, regulatory, CMC , and project management to ensure completion of clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Portfolio Management Lead where you will ensure that the PharmSci ... of the PS Program Leadership, you will report to Head, Pharmaceutical Sciences PMO. **How you will contribute:** **Objectives of the role:** + **Cross-Functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …As part of the Analytical Development team, you will report to Director , Analytical Development. **How you will contribute:** + Develops project and technical ... of expertise. + Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience + PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science + Experience in CMC pharmaceutical development for active ... scientific technology and influences strategic planning within AD and across Pharmaceutical Sciences to deliver on program strategy and initiatives. You will also… more