Job Title: Senior Scientist II
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 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.
- Write protocols, reports, methods and standard operation procedures
- Write regulatory submission modules and any other documents to support submission and product approval.
- Develop statistical design of experiments with minimal supervision.
- Independently design and develop manufacturing processes and conduct manufacturing activities for inhalation drug products.
- Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
- Provide expert support for analytical and/or manufacturing related technical issues.
- Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites.
- 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.
- Independently lead major project tasks.
- Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs or 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 9 years; MSc with at least 11 years or BSc with at least 14 years of experience in pharmaceutical or related fields.
- Broad knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or broad 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 Deep knowledge of FDA cGMP requirements as they apply to the Pharmaceutical industry.
- Strong English language skills including writing ability and oral communication