Senior Manager, Sterile Liquid Formulations

Job Summary

Independently conducts, leads, and supervises standard and advanced laboratory and commercial scale-manufacturing activities as applied to sterile liquid formulations. Lead development of new formulations and manufacturing processes. Lead process scale-up and transfer activities. Lead selection, installation, qualification and maintenance of aseptic processing equipment. Lead third party manufacturing activities. In the R&D product development environment, lead the evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development activities for sterile liquid dosage forms. Brings expertise in application of current regulatory guidelines, industry best practices, US FDA cGMPs recommendations, EU requirements and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations, data reviews and coaches and trains junior scientific staff.

Essential Duties and Responsibilities

• This is a hands-on position where the candidate is required to lead development of sterile liquid dosage forms at the laboratory scale, pilot scale and commercial scale.
• Independently conduct, lead and supervise standard and advanced laboratory activities for the development of sterile liquid formulations following regulatory guidelines, industry best practices, US FDA cGMPs, EU guidelines, and other relevant guidelines.
• Lead development of new formulations and manufacturing processes.
• Lead process scale-up and transfer activities.
• Lead selection, installation, qualification and maintenance of aseptic processing equipment.
• Lead third party development and manufacturing activities.
• In the R&D product development environment, lead the evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development activities for sterile liquid dosage forms.
• Independently design and develop manufacturing processes and conduct manufacturing activities for sterile liquid formulation based dosage forms and drug delivery concepts.
• Possess good understanding of formulation and processing technologies.
• Possess good understanding of aseptic fill-finish processes and technologies.
• Possess good understanding of sterilization processes and technologies.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for manufacturing related technical issues.
• 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.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with Transpire Bio and Transpire Bio partner companies’ team members.
• 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; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• Ph.D., in Pharmaceutical Sciences, Pharmaceutics, Material Sciences, Chemistry, Chemical Engineering or related discipline with 7 to 12 years, MS with 12+years research experience in pharmaceutical or related field. 
• Must possess expert knowledge of formulation development.
• Must possess knowledge of manufacturing processes for sterile formulations and aseptic fill-finish techniques.
• Extensive experience in generic product development (505j ANDA) is a must to have.
• Extensive experience with writing chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD) is a must to have.
• Demonstrated experience in successful product development, registration and commercialization is a must to have.
• Knowledge and in-depth understanding of global regulatory requirements as applied to formulation and process development.
• Excellent understanding of USP methodologies and ICH guidelines. Deep knowledge of the FDA cGMP requirements as they apply to the pharmaceutical industry.
• Strong English language skills including writing ability and oral communication.