What are the responsibilities and job description for the Senior Scientist, Analytical R & D, Peptide Characterization position at Stira Pharmaceuticals?
Company Description:
Stira Pharmaceuticals is a Sterile Injectable CDMO specializing in pharmaceutical product development and manufacturing of small molecules and peptides. The company's team of skilled scientists uses in-house technology platforms and extensive prior experience to develop challenging products. Stira Pharmaceuticals offers a range of services including Analytical R&D, Preformation, Formulation Development, Manufacturing and Regulatory Support.
Role Description
This is a full-time on-site role for an Analytical Scientist, Peptide Characterization at Stira Pharmaceuticals in the New York City Metropolitan Area. The Analytical Scientist will be responsible for developing and validating analytical methods, conducting peptide characterization using laboratory skills, and ensuring compliance with Good Manufacturing Practice (GMP) standards.
Key Responsibilities:
- Develop and validate analytical methods for the characterization and quantification of peptides and peptide-based products.
- Perform routine and complex analyses using techniques such as H/UPLC, HRMS, SEC-MALS, CD, SV-AUC, Dynapro Plate reader, Zetasizer, AF4 (Asymmetrical flow field-flow fractionation), AFM, Cryo-TEM, SEM-EDS and other relevant analytical instruments.
- Peptide Sameness studies as FDA guidance
- Collaborate with cross-functional teams, including R&D, Quality Control, and Regulatory Affairs, to support product development and ensure compliance with industry standards and regulations.
- Interpret and present analytical data, preparing detailed reports and documentation for regulatory submissions.
- Troubleshoot and resolve analytical issues, optimizing methods to improve accuracy, precision, and efficiency.
- Stay current with advancements in analytical techniques and peptide chemistry, incorporating new knowledge into project work.
- Train and mentor junior staff in analytical methods and best practices.
Qualifications:
- Ph.D. or master’s degree in Analytical Chemistry, Biochemistry, or a related field with a focus on peptide chemistry.
- Minimum of 2-4 years of experience in an analytical laboratory setting, preferably in the pharmaceutical or biotechnology industry.
- Proficiency in analytical techniques such as H/UPLC, HRMS, SEC-MALS, CD, SV-AUC, Dynapro Plate reader, Zetasizer, AF4 (Asymmetrical flow field-flow fractionation), AFM, Cryo-TEM, SEM-EDS and other relevant analytical instruments.
- Strong understanding of peptide chemistry, including synthesis, purification, and characterization.
- Experience with regulatory requirements and guidelines (e.g., FDA, ICH) for analytical method development and validation.
- Excellent problem-solving skills and attention to detail.
- Strong written and verbal communication skills, with the ability to present complex data clearly and concisely.
- Ability to work independently and collaboratively in a fast-paced, multidisciplinary environment.
- Demonstrated ability to manage multiple projects and prioritize tasks effectively.
Benefits:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and innovative work environment
- Access to cutting-edge technology and resources
