Pharmaceutical Development Technician/Technologist
2 weeks ago
Summary
Independently conducts, leads and supervises standard and advanced laboratory activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. Independently conducts, lead and supervises manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches. Provide practical feedback towards study designs, development of documents and selection of manufacturing equipment. 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. Initiates investigations, data reviews and coaches and trains junior scientific staff.
Essential Duties and Responsibilities
Independently conducts, leads and supervises standard and advanced laboratory activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites.
Independently conducts, lead and supervises manufacture of lab scale R&D, pilot scale, pivotal scale and commercial scale batches by following written documentation.
Provide practical feedback towards study designs, development of documents and selection of manufacturing equipment.
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.
Initiates investigations, data reviews and coaches and trains junior scientific staff.
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.
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 15 years of work experience.
A relevant degree, certification, or license may be required.
Must have experience as a technician in the manufacture of pharmaceutical products in a GMP manufacturing environment
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.
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