Head of CMC - Boston, MA

We're not just looking for the brightest minds or for the most brilliant individual contributors.We want passionate team members who are comfortable adjusting their lens, aren't afraid to think big, test bold ideas, and celebrate collective wins. · ...

This CMC and QA leadership role is key to progressing HotSpot's programs to clinical development. · In consultation with senior advisors, lead CMC strategy and execution to support delivery of HotSpot development programs. · ...

+Job summary · We are seeking a CMC Biostatistician to join the Translational and Early Development (TED) team within Global Biostatistical Sciences (GBS).++Degree in Statistics, Biostatistics, Mathematics, or a related scientific field · Experience providing statistical support ...

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. · Reporting to the Head of Regulatory Affairs CMC, · ...

Reporting to the Head of Regulatory Affairs CMC, the Director, Global Regulatory Affairs – CMC is responsible for owning and leading the global CMC regulatory strategy and execution to enable clinical development, · commercialization, · and lifecycle management of the company's p ...

· Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescript ...

+Job summary · We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.+ResponsibilitiesLead and own the global CMC regulatory strategy f ...

Reporting to the Head of Regulatory Affairs CMC, the Director serves as the single-point CMC regulatory lead for assigned programs across development and commercialization. · ...

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases. · ...

The Director CMC Project Management will be responsible for managing CMC drug development activities. · Provide leadership to cross-functional teams in the oversight, design and execution of process and analytical validations. · Manage cross-functional project CMC sub-teams for m ...

Elektrofi is seeking an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. · This role will serve as the primary technical and strategic interface between internal cross-functional teams, external partners, and regulatory authorities to ens ...

We are seeking a manager of CMC Analytical Development to help drive successful inhaled product development. · ...

Elektrofi is seeking an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. · ...

We are seeking a manager of CMC Analytical Development to help drive successful inhaled product development. The individual will work collaboratively with the Head of Analytical and cross-functionally within CMC to plan, track and report the release, stability and high-quality da ...

The Chief of Staff will drive the execution of Pharm Sci strategy to increase business performance. They will partner with PS, partners and leadership to identify and lead enterprise-wide transformation initiatives. · Drive the execution of Pharm Sci strategy. · Partner with PS, ...

The Chief of Staff will drive execution of Pharm Sci strategy to increase business performance while increasing speed for CMC deliverables. · Drive strategic programs across global sites in Boston, Vienna, and Shonan. · Partner with senior stakeholders in Finance R&D GMS GQ Regul ...

The Vice President of Commercial Operations will lead Skyhawk's commercial operations capabilities ensuring commercial readiness and optimizing planning and execution for SKY-0515. This role will partner with vendors on implementation and roll out of key commercial infrastructure ...

About the role · The VP, Head of Regulatory Affairs is the company's senior regulatory executive and a member of the leadership team. This leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The V ...

A biotech company seeks a Technical Project Manager to establish and build out their Project Management Office (PMO) infrastructure. · Selecting project management software platforms for best results. · Migrating core portfolio data off Excel into selected system(s). · ...

A biotech company is seeking a Technical Project Manager to establish and build out their Project Management Office (PMO) infrastructure. The organization currently manages its portfolio using Microsoft Excel and is ready to transition to a more robust solution. · The ideal candi ...