Summary
Conducts laboratory activities including manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. Conducts manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches. Contribute towards installation, maintenance and troubleshooting of manufacturing equipment and interface with equipment vendors. Contribute towards development of orally inhaled and nasal drug products (OINDPs) by following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines. Contribute towards the development and evaluation of new formulation manufacturing technologies where required.
Essential Duties and Responsibilities
- Conducts standard and advanced laboratory activities including manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites.
- Conducts manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches by following written documentation.
- Contribute towards installation, maintenance and troubleshooting of manufacturing equipment and interface with equipment vendors.
- Contribute towards development of orally inhaled and nasal drug products (OINDPs) by following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
- Contribute towards creation and review of R&D, pilot, pivotal and commercial manufacturing batch records according to cGMPs and Transpire Bio’s SOPs.
- Execute manufacturing batch record and report all laboratory and manufacturing activities according to cGMPs and Transpire Bio’s SOPs.
- Work and communicate effectively with other functional groups and across global respiratory R&D sites.
- 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
- High school diploma with 5 years of work experience.
- A relevant degree, certification, or license may be required.
- Experience as a technician in the manufacturing of pharmaceutical products.
- Experience in the manufacturing of solid dosage forms like tablets, capsules, dry powder inhalation products, is required. (MUST HAVE)
- Experience in the manufacturing of sterile, injectables, ophthalmic products is preferred.
- A driver’s license.
- Ability to multitask and liaise with professionals in different fields.
- Ability to explain problems simply and clearly.
- Proficiency in MS Office.
- Exercise independent judgement and discretion.
- Ability to understand verbal and written instructions.
- Ability to follow health and safety regulations.
- Excellent mathematical and problem-solving skills.