Job Title: Senior Principal Scientist
Site: Miami, Florida
Function: CMC
Department: Transpire Bio
Essential Duties and Responsibilities
- Supervise standard and advanced laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
- Introduce new concepts, products, equipment or processes to develop new applications. Develop technical solutions to complex problems which require the regular use of ingenuity and creativity.
- Evaluate and introduce new technologies to improve productivity and efficiency; be capable of generating new practical ideas and apply broad knowledge of related disciplines; drive continuous process improvement.
- Conduct complex formulation experiments to test, prove or modify applications based on applied research.
- Design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
- Provide expert support for analytical and/or manufacturing related technical issues, analyzing data, identifying solutions, and implementing recommendations.
- Knowledge of legal and patent requirements as they pertain to product development.
- Write regulatory submission modules and any other documents to support submission and product approval.
- Develop statistical design of experiments and analyze/evaluate results.
- Perform structure elucidation on unknown impurities. Provide possible formation pathways for degradation impurities and recommend preventive solutions.
- Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites.
- Mentor and assist junior scientists.
- Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers.
- Work and communicate effectively with other functional groups and across global inhalation R&D sites. Present development activities, findings and recommendations to global teams and management.
- Lead internal/external projects on specific CMC topics, independently and within a team environment.
- Proactively contribute to innovative ideas and generation of innovative opportunities
- Proactively influence decisions on CMC
- Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs; follow Corporate safety rules and procedures.
- Comply with all Corporate guidelines and policies.
Qualification Requirements
- PhD in Chemistry or Pharmacy or related fields with at least 15 years; MSc with at least 17 years or BSc with at least 20 years of experience in pharmaceutical or related fields.
- Extensive knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or extensive knowledge of development and manufacturing activities for MDI/DPI/Nasal products.
- Experience leading multifunctional project teams and able to multi-task effectively.
- Knowledge and detailed understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH Extensive knowledge of FDA and cGMP requirements as they apply to the Pharmaceutical industry.
- Strong English language skills including writing ability and oral communication.