Location: Fort Lauderdale,FL, USA
JOB SUMMARY
Independently conducts, leads and supervises standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for Orally Inhaled and Nasal Drug Products (OINDPs) following regulatory guidelines, industry best practices, US FDA cGMPs, 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.
NOTE: A Ph.D qualification is required for the more senior levels of this role- SEE Qualification Requirements below.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Independently conduct, lead and supervise standard and advanced laboratory activities for the development of OINDP formulations following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
Independently design and lead pre-formulation, formulation and process development studies to recommend selection of APIs, excipients, packaging material and manufacturing process.
Independently design and develop manufacturing processes and conduct manufacturing activities for OINDP products.
Possess good understanding of other inhalation 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
Associate Scientist I/II - BS Degree in Chemistry, Chemical/Biochemical Eng., Biochemistry or a related scientific discipline. BS degree with 1-5 years experience OR an MS degree with 0-3 years' experience is required.
Scientist I- Ph.D., in Pharmaceutical Sciences or related discipline with 3 years research experience in pharmaceutical or related field.
Scientist II/Sr. Scientist- Ph.D., in Pharmaceutical Sciences or related discipline with 5-6 years research experience in pharmaceutical or related field.
Should possess expert knowledge of development orally inhaled and nasal products (OINDPs).
Knowledge of manufacturing processes of OINDP products is a plus.
Knowledge and in-depth understanding of global regulatory requirements as applied to OINDPs.
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. Experience with writing of chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD).