Pyros Pharmaceuticals develops high-quality, proprietary specialty pharmaceuticals for rare diseases with high unmet needs. Research and development are the cornerstones of our growth strategy. Providing quality products through scientific innovations and precision medicine is the goal of all of Pyros’ research programs.
The Scientist, reporting to the Associate Director, Product Development, will provide support for the formulation and process development activities at CDMO/CMO using concepts of Quality by Design (small molecules in injectable and oral dosage forms preferred) for ANDAs and NDAs. Experience with peptides chemistry and characterization techniques is a plus.
- Applying a working knowledge of formulation sciences, the scientist will support pharmaceutical product development from development phase till commercialization of the product that includes but is not limited to pre-formulation, formulation, and process development by partnering with CDMOs.
- Prepare or review protocols and reports for testing associated with pre-formulation studies, overall formulation design, filter validations, manufacturing equipment/components compatibility, container closure selection, E&L studies and similar.
- Reviews documentation including pre- and post- execution manufacturing and packaging batch records, tech-transfer protocols/reports, process validation protocols/reports, stability protocols/reports, method validation protocols/reports, investigations and deviations and related corrective and preventive actions.
- Critically review, interpret, and present study results to the team, perform root cause analysis and troubleshoot any issues to derive study conclusions independently or under the guidance of a department leader.
- Actively participates in scientific discussions on projects with cross-functional teams internally and externally.
- Under the guidance of team lead or department leader, manage multiple projects simultaneously to meet deadlines.
- Authoring, reviewing, and maintaining relevant SOPs, technical reports, and various study designs to support ANDA/NDA submissions.
- Review relevant CMC sections for ANDA/NDA submissions in timely manner. Collaborate with external partners to prepare and procure documentation suitable for such regulatory submissions.
- Additional responsibilities as assigned to meet company requirements and policy for this role.
Skills & Requirements
- Hands on experience working in formulation lab and reviewing production batch records.
- Working knowledge of analytical methodology and ability to interpret data to derive conclusions
- Strong communication and technical writing skills.
- Knowledge of regulatory systems and guidelines such as USP/EP/BP, ICH, FDA
- Must be able to effectively communicate in a fast-paced multi-disciplinary environment.
- Experience managing multiple projects simultaneously.
- Experience in the unique requirements associated with the development and manufacture of sterile peptide products is desirable.
- Some travel to CDMO may be required (< 10%) on need basis.
- BS in pharmaceutical sciences or similar with 6+ years of pharmaceutical experience or MS degree with 4+ years of experience.
- Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required.
- Ability to work independently and in a team environment.
Submit your resume below or send your resume to [email protected].
Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.