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The purpose of the Research Scientist role is to provide strategic, tactical and operational direction to expedite CMC development of our company's portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Research Scientist to develop collegial and mutually productive relationships across our company's components, partner company components, and with Agency personnel. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing, and GRA leadership on these positions.
Regulatory & Scientific Expertise
- Deep technical knowledge and understanding of CMC drug development and manufacturing science(s)
- Recognized across GRA, development, and manufacturing as an expert having a broad technical knowledge of global CMC regulatory requirements and guidelines as well as deep knowledge in one or more specialized areas of regulatory.
- Utilizes specialized regulatory expertise to develop and lead implementation of new regulatory practices based on changes in the external environment.
- Makes technical decisions on CMC regulatory issues that set new standards impacting CMC submissions across multiple programs and geographies
- Provide high quality, timely and decisive regulatory advice to allow CMC Teams to make well-informed decisions on development or product lifecycle planning
- Anticipates and resolves key technical or operational issues that have the ability to impact the function, CMC team and/or submission timing. Actively engages in submission development activities, which include evaluating CMC team deliverables for scientific rigor and regulatory impact.
- Takes on risky (i.e. technically challenging, political) problems and identifies creative and/or alternative solutions, networking for input with GRA-CMC, development, and manufacturing management if needed.
- Demonstrated ability to influence CMC team members with various backgrounds and personalities and their management to achieve the goals of the team.
- Networks throughout GRA, as appropriate, building awareness and alignment on CMC Regulatory strategies.
- Recognized as model of strong leadership behaviors and provides mentoring to colleagues on technical and regulatory topics.
- Leads strategic initiatives to incorporate new regulations, guidance, and company positions into our company's processes/guidelines, tools, and/or training materials, while building in efficiencies.
- Influences internal policy development and provides internal input on emerging regulations worldwide for CMC issues
- Viewed as a valued contributor to industry organization(s), effectively increasing our company’s visibility and influence of evolving regulatory positions.
Lead / Partner
- Creates and manages timelines for development of CMC registrations, resolving major issues and conflicts via networking directly with CMC team members, and when necessary, their line management and GRA-CMC management
- Leads preparation, review and finalization of CMC documents for global regulatory submissions and responses to questions.
- Networks and gains alignment with CMC team members and development and manufacturing line management to resolve complex issues.
- Develop relationships with peers and line management in other company functional areas (e.g., bioprocessing, toxicology, manufacturing, quality, tech services) that promote open discussion of issues to enable regulatory influence of drug development and manufacturing strategies.
- Communicates effectively verbally and in writing to influence within work group/function and with other company partners
- Proactively identifies and resolves global CMC regulatory issues, leveraging internal experts to develop complex regulatory strategies
- Participate in forums that share regulatory information across GRA / PR&D / manufacturing.
Minimum Qualification Requirements:
- Bachelor’s Degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
- Prior Regulatory CMC experience (7 - 10 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
- Pharmaceutical industry experience in a CMC-related field (7 – 10 years) will also be considered.