Principal Scientist, Formulation Development, Pioneering Medicines

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments. 

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.  

 

Position Summary:

Pioneering Medicines seeks a Principal Scientist (PS), Formulation Development to act as a subject matter expert across multiple assets. The PS will be responsible for pre-formulation, formulation, process development and technology transfer activities. The PS will be a key member of the TechOps organization and contribute to creating, growing, and building Pioneering Medicines into a world-class biopharmaceutical R&D capability within Flagship Pioneering.

 

The Principal Scientist will work closely with the CMC (Chemistry Manufacturing & Controls) team leader and scientific experts within TechOps and other functions. The position requires demonstrated scientific leadership and a strong track record in developing both standard and complex formulations. Critical thinking, multitasking, scientific curiosity and being a strong team player are key to be successful in the role.

Responsibilities:

• Establish, own and execute formulation / process development strategy for traditional and emerging modality projects
• Act as key member of CMC sub-team by contributing to platform & functional initiatives through direct contributions and leading matrix teams
• Develop robust formulation and process understanding based on strong scientific framework, well-structured experiments and use of statistical approaches
• Support the build-out of PMs internal lab by identifying high value opportunities and identifying / implementing relevant cutting-edge technologies and capabilities
• Accountable for troubleshooting and resolving highly complex formulation challenges
• Work independently and collaborate in a fast-paced, integrated, multidisciplinary team environment
• Contribute to the scoping, assessment and selection of CDMOs (Contract Development and Manufacturing Organizations). Execute and oversee technical transfers, scale up and clinical manufacture at CDMO facilities
• Represent Pioneering Medicines as a subject matter expert in formulation / process development aspects with internal / external partners and industry forums
• Routinely document and present formulation development activities to key stakeholders and at relevant management forums
• Hire & mentor junior scientists to develop appropriate internal capabilities, as needed
• Author and review technical reports, IND / IMPD (Investigational New Drug / Investigational Medicinal Product Dossier) modules, patents and external publications

Minimum Qualifications:

• Education in Pharmaceutics, Bioengineering or relevant scientific discipline
• PhD with 5+ years, MS with 10+ years, or BS with 12+ years formulation development experience
• Demonstrated scientific leadership in pre-formulation, formulation, process development and technology transfers
• Hands-on experience in two or more modalities (small molecules, biologics, peptides, nucleic acids) is preferred
• Expertise in developing formulations across multiple routes of administration (eg. oral, inhalation and injectables) and complex dosage forms (eg. enabled oral formulations, long acting injectables) is preferred
• Experience in Quality by Design (QbD) studies, applying statistical approaches and robust data analysis/interpretation
• Demonstrated ability to develop solutions to complex problems, and troubleshoot with creativity and innovation
• Ability to support multiple projects and as part of a matrixed team in a highly dynamic, fast-paced environment with evolving priorities
• Experience in authoring CMC sections for IND/IMPD and supporting Health Authority inspections.
• Experience in