Job Title: 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.
- Design, develop and supervise the execution of approved method transfer protocols, development and validation of all analytical methods including excipients in drug products.
- Write regulatory submission modules and any other documents to support submission and product approval.
- Independently develop statistical design of experiments.
- Independently design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
- Perform structure elucidation on unknown impurities. Provide possible formation pathway for degradation impurities and recommend preventive solutions.
- 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.
- Provide expert support for analytical and/or manufacturing related technical issues, analyzing data, identifying solutions, and implementing recommendations
- 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 respiratory R&D sites.
- Lead internal/external projects on specific CMC topics within a team environment.
- Contribute to innovative ideas and generation of innovative opportunities.
- Influence decisions on CMC
- Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs & STPs; follow Corporate Health & Safety rules and procedures.
- Comply with all Corporate guidelines and policies.
Qualification Requirements
- PhD in Chemistry or Pharmacy or related fields with at least 12 years; MSc with at least 14 years or BSc with at least 17 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 inhalation products.
- 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 the FDA cGMP requirements as they apply to the Pharmaceutical industry.
- Strong English language skills including writing ability and oral communication.