We are currently seeking a Formulation Scientist (Material Science II). This position is in Columbus, OH.
This scientific leadership role will be responsible for formulation development and investigating physiochemical characterization methods of nucleic acid and nucleic acid-protein complex delivery formulations.
This role is set within the delivery group of the Biotechnology Solutions to support pre-clinical and clinical development all the way up to commercialization. In addition, the candidate should be able to contribute formulation selection and characterization source documentation to support product development and regulatory submissions. This position requires exceptional time management and communications skills with strong attention to detail. A breadth of knowledge of analytical tools and techniques applied to materials science, colloidal structure and stability, nanotechnologies for formulation design, nucleic acid drug delivery and general pharmaceutical R&D is required.
- The candidate will be responsible for conducting experiments in support of developing, evaluating, and characterizing novel formulations/processes, components and supporting delivery technologies for diverse therapeutic modalities including (but not limited to) RNA-based therapeutics/vaccines, nanoparticle modality, mammalian and microbial fermentation derived candidate molecules, vaccines, plasmids, and peptides.
- This individual function's cooperatively with other members of the team to achieve the project goals.
- The incumbent displays technical awareness in various aspects of drug discovery and development, strong drive for learning new techniques and rigorous scientific method and commitment to the scientific process.
- Maintain accountability for project success and results delivery.
- Specific responsibilities include:
- Provide technical representation and subject matter expertise (SME) in cross functional formulation, process, and analytical investigations for RNA- and nanoparticle-based modality formulation and processes.
- Design, execute, and analyze experiments for existing and novel modalities. Define the formulation, the critical parameters, and the design space.
- Support development of novel characterization techniques to characterize lipid nanoparticles to support process development and formulation design.
- Lead experiments to confirm robust process performance across the control space.
- Compile experimental and analytical results, perform data interpretation, summarize, and report on data with conclusions and recommended next steps.
- Characterize nanoparticle properties and prepare technical reports, communicate findings internally and externally, and present in cross-functional meetings.
- Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
- Optimize current processes to ensure robust manufacturing.
- Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes.
- Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates.
- Communicate research and development findings internally and externally.
THE FOLLOWING IS REQUIRED
- Demonstrates ownership and can see things through (end-to-end).
- Applicants for this position must be a U.S. Person, as defined by U.S. export control laws.
- Sound understanding of when decisions should be made / elevated.
- Conceives and drives line initiatives, technology development and CMC strategy.
- Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.
- Strong work ethic and attention to detail.
- Excellent interpersonal skills and ability to work with others in a dynamic and highly collaborative environment.
- Specific technical skills:
- Demonstrated ability to trouble-shoot nanoparticle formulation and fabrication processes and scale-up issues.
- Experience in nucleic acid drug development (DNA, RNA, oligonucleotides) or nanoparticle delivery technologies.
- Experience in nanoparticle/ LNPs /large molecule/mRNA drug product formulation development and late-stage development is a desired.
- Experience with a variety of analytical techniques including UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, DSC.
- Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.)
- Effective communication skills and the ability to write detailed technical reports.
- Solid foundation in Formulation, analytical, chemistry, material science, and nano-particle characterization.
- Experience with nanoparticle drug delivery systems.
- Good understanding of lipid and polymeric nanoparticle technologies.
- Minimum: M.S. required. Desire 2 or more years of industrial experience in Pharmacy, Pharmaceutics, Analytical Chemistry, Biophysics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.