Pharmaceutical Development Technologist at Transpire BIO Inc.

Weston, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

0.0

Posted On

13 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Formulation Development, Manufacturing Process Scale-up, Process Transfer, OINDP Development, cGMP Compliance, Laboratory Supervision, Equipment Troubleshooting, Data Review, MS Office, Problem Solving, Mathematical Skills, Technical Documentation

Industry

Biotechnology Research

Description

Position Summary The Pharmaceutical Technologist 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. Required Qualifications * High school diploma with 15 years of work experience. * A relevant degree, certification, or license may be required. * Experience as a technician in the manufacture of pharmaceutical products. * 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. Preferred Qualifications * Experience in a regulated laboratory (pharma, biotech, medical device) * Knowledge of GMP, GLP, or ISO standards Physical & Work Environment Requirements * Ability to stand for extended periods * Ability to lift up to 30 lbs * Work in a laboratory environment with biological materials and disinfectants * Wear appropriate PPE including lab coat, gloves, and eye protection WHY JOIN US? We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.

Responsibilities

Lead and supervise pharmaceutical formulation and manufacturing process development from lab scale to commercial scale. Contribute to the development of orally inhaled and nasal drug products while ensuring compliance with FDA cGMPs and regulatory guidelines.