API Technology Transfer Specialist

Quick Facts

• Role: API Technology Transfer Specialist

Description

Support R&D teams in optimizing and validating new API manufacturing processes in the PDLU laboratory. Contribute to HAZOP and FMEA risk analyses, select production equipment for kilo-lab and pilot scales, and review technology and production documentation. Oversee trial and validation series manufacturing at kilo-lab and pilot facilities and collaborate on deviations and change-control protocols.

Responsibilities

• Support technologists in R&D during optimization and validation of new API production processes in the laboratory (PDLU)

• Participate in HAZOP and FMEA risk analyses

• Select production equipment for kilo-lab and pilot-scale manufacturing

• Review technology and production documentation

• Join internal project meetings on transferring technology from R&D to kilo-lab and pilot scale

• Participate in project meetings with customers (CDMO)

• Supervise manufacturing of trial and validation batches in kilo-lab and pilot facilities

• Work with kilo-lab and pilot staff to explain deviations and develop Change Control Protocols

Requirements

• Higher education in chemistry or a related field

• Experience in a similar role or in API production or R&D at an API manufacturing company

• Practical project management skills (project documentation and creating project presentations)

• Specialist knowledge of API manufacturing and hands-on knowledge of operating process equipment used in API production

• Experience working in a GMP environment

• Very good English

• Good organization and ability to manage multiple tasks

Benefits

• Stable employment under a work contract

• Base salary + bonuses

• Private medical care

• Lunch card (400 PLN)

• Subsidy for commuting

• Multisport card

• Group life insurance

• Employee Pension Program (PPE)

• Motivizer cafeteria points

• Holiday gifts and events for children

• Christmas/New Year vouchers

• Vacation funding