The Role:
Reporting to the Associate Director, Formulation Sciences, the Senior Scientist / Senior Manager, Formulation Sciences will follow programs through the development stages and play a pivotal role as a drug product subject matter expert in supporting all matters relating to drug product development and manufacturing. The successful candidate needs to demonstrate a proven record of working in a virtual environment with CDMOs to deliver products and manufacturing processes for the generation of clinical trial material in support of fast-paced clinical development programs. With strong technical aptitude, the Senior Scientist/Manager will lead technical transfers, oversee drug product process development and manufacturing, and design DOEs to proof a process design space.
This individual will support formulation development, scale up, and manufacturing activities across Nuvalent’s contract research and manufacturing organizations. The candidate will immediately assume responsibilities and contribute to the development of a clinical stage program, as well as provide subject matter expertise and overall technical leadership to lead drug product development.
Responsibilities:
The successful candidate will support the company through the following areas/interactions:
- Responsible for drug product formulation and process design, optimization, scale-up, and technology transfer.
- Oversight of external drug product manufacturing by providing guidance to CDMOs.
- Support discovery programs as they seek suitable formulations for preclinical studies.
- Ensure relevant data is captured in reports provided by external CROs/CMOs.
- Identify key knowledge gaps and execute plans to ensure our process understanding is commensurate with a given program’s stage of clinical development.
- Ensure that the formulation and process development is compliant with both relevant regulations and regulatory commitments.
- Draft tech transfer packages, review and provide feedback of batch records and development reports, manage internal timeline, and monitor development and manufacturing progress.
- Efficiently work cross-functionally with project teams including QA, analytical, drug substance development, and supply chain.
- Support authoring of the relevant technical sections of regulatory filings.
- Effectively manage drug product development activities working in a virtual environment.
Competencies:
- Excellent organization and multi-tasking skills.
- Experience building positive and effective cross functional re
- Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
- Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
Qualifications:
- PhD in pharmaceutics, pharmaceutical sciences, chemical/biomedical engineering or related field.
- 3+ years or MS/BS with 6+ years of industry experience.
- Proven track record on phase appropriate drug product formulation development (i.e., IND-Enabling) and solving formulation and manufacturing challenges.
- Experience with implementation of QbD strategies and DoE approach during development is a plus.
- A good understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
- Manage the outsourcing (formulation/process development and manufacturing) activities at CDMO sites to meet CMC goals.
- Mastery of current ICH guidelines and related industry guidelines and practices.
- Ability to author and review relevant development reports as well as regulatory dossiers.
- 20% travel (domestic and international) is expected.
