Title: Analytical Development Research Scientist
Location: Indianapolis, IN
Start date: ASAP
- As part of a multi-disciplinary team in BRD Analytical, responsible to define the use of analytical control strategies and the use of analytical, bioanalytical and characterization methods to design an integrated control strategy enabling process and product development.
- Responsible for the development and application of technical capabilities to the portfolio of biosynthetic molecules, synthetic small molecules and peptides.
- Understands and complies with corporate, divisional, and departmental procedures, including GMP, safety, and other regulations.
- Demonstrates technical excellence at performing and assessing multiple analytical methods to enable oversight of third-party labs.
- Displays comprehensive knowledge of various techniques to enable troubleshooting and problem solving (e.g., HPLC, GC, X-ray diffraction, Karl Fischer, UV, MS, Dissolution, Disintegration, compendial and parenteral tests – particulates).
- Develop all or portions of analytical control strategies including reference materials.
- Oversight of development and verification / qualification / validation of methods to support in-process, release, characterization analysis, and stability testing of active pharmaceutical ingredient and drug product.
- Openly shares technical knowledge and key learning.
- Establishes relationships with key business partners.
- Workday flexibility and effective at various forms of communication to enable participation in global team interactions.
- Effectively guide and oversee external work at collaboration partners.
- Demonstrates proficiency at data reporting, interpretation and trending (e.g., Empower chromatography software, and electronic laboratory notebooks)
- Demonstrates good documentation skills with regard to raw data recording and authoring of technical and regulatory documents (e.g., technical reports, data integrity reviews, and submission components).
- Maintain awareness of external environment (industry and regulatory).
- Ph.D. in Analytical Chemistry, or related field; alternatively, skills commensurate with a Ph.D. Chemist. Up to 80% remote.
- Previous pharmaceutical industry experience (preferably 5+ years) required.
- Chemistry experience with knowledge of one or more of the following, as appropriate: separation sciences, biophysical/ biochemical characterization, and bioanalytical sciences.
- Experience in biosynthetic, synthetic small molecule, peptide, process development and analytical development recommended.
- Capable of designing experiments and interpreting results independently.
- Problem solving and decision-making.
- Effective oral and written communication skills, self-management, task planning and organization.
- Must be able to work productively in an interdisciplinary team environment.
- Experience with the drug development process, including knowledge of regulatory compliance issues.
- Fundamental knowledge of cGMP/GLP compliance requirements.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.