Job Title: Scientist I
Site: Miami, Florida
Function: CMC
Department: Transpire Bio
Essential Duties and Responsibilities
- Conduct standard and advanced laboratory activities with minimal supervision 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.
- Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
- Execute approved method transfer protocols, develop and validate cleaning validation methods.
- Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform basic statistical calculations.
- Write protocols, reports, methods, standard operation procedures, and submission documents with supervision.
- Conduct manufacturing activities for drug products with limited supervision.
- Support the evaluation and introduction of new technologies.
- Independently train other scientists.
- Participate in project activities and support project timelines and proactively contribute to meeting team objectives. Communicate effectively with team members and internal or external customers. Work effectively with other functional groups. Lead small project tasks effectively, with some supervision.
- 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 0-2 years; MSc with 3-5 years or BSc with a minimum of 5 years of experience in pharmaceutical or related fields.
- Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or basic knowledge of development and manufacturing inhalation drug products.
- Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH
Strong English language skills including writing ability and oral communication.