Principal Scientist, Bioanalytical Development (Remote-based)
The (remote-based) Principal Scientist, Bioanalytical Development, will support Catalent Biologics for the development and manufacturing of client products and processes. The network role is a new one and will be an exciting opportunity to align best practices and build capability. Responsibilities include supporting cross-functional efforts at 2 of the US DP Biologics sites by driving and sustaining formulation and drug product process development linked to manufacturing. Collaboration with the broader US and EU biologics leads will also be important. A strong collaborator is needed who will work effectively across functions and sites. The Principal Scientist will be based in the US and will report to the Director, Integrated Network and will also work with the site PD Directors. Some travel to relevant sites will eventually be needed to evaluate capabilities and implement projects.
- Lead and support biologics analytical development and method transfer for client programs.
- Apply biochemical and biophysical methods as needed for routine testing and deep characterization.
- Assess transferred methods and develop new protein analytical methods.
- Assure work is informed by knowledge of molecule structure function and biochemistry and protein degradation mechanisms
- Collaborate with QC to assure that stability work is effectively planned and informed by biologics molecular structure.
- Using statistical knowledge and understanding of phase appropriate needs guide decisions and/or impact of specifications.
- Actively contributes to the strategic direction of the biologics network by recommending expansion or curtailment of investigations based on experimental results or scientific information
- Collaborate on technical transfer and scale-up support with MS&T and operations across as needed across the network
- Support client visits and working teams
- Applies technical, functional, and industry knowledge to design and evaluate methods via DOE/QbD approach, review and analyze data, frame early and late phase needs
- Review technical documents for accuracy, thoroughness, and regulatory compliance
- Train, coach, and mentor others in BIO development/MS&T and quality control
- Participates in or leads client meetings offering technical support and leading the project; collaborate with other Catalent team members
- Develop and administer training webinars and courses for analytical development including planning and leading internal and external workshops
- Routinely suggests new, innovative solutions to routine and complex problems.
- Support strategic efforts for new and evolving methods
- PhD in Chemistry, Biochemistry, or related scientific field with 8+ years of related industry experience
- MSc in Chemistry, Biochemistry, or related scientific field with 12+ years of related industry experience
- Experience in bioanalytical development, deep knowledge of biologics analytical development strategies, and familiar with current industry best practices
- Experience in biochemical and biophysical methods for biologics molecular structure routine testing and deep characterization. Familiar with the relationship of biologics molecular structure to stability
- Experience developing protein analytical methods including characterizing degradation of biologics molecule, familiar with biologics drug product degradation mechanism.
- Familiar with the fill-finish process impact to the biologics product quality
- Experience with preparation of regulatory documents including FDA (BLAs, INDs, briefing documents) and EMA (CTD, MAA) and ICH Guidelines
- Demonstrated problem-solving skills and written/verbal communication skills
- Ability to work independently within a team environment
- Demonstrated interpersonal skills to build relationships, act as a change agent, and adapt to rapidly changing organizational and business needs
- 8-12+ years of experience related experience required and GMP experience preferred