Scientist / Engineer – Drug Product Technical Transfer & Fill-Finish (JP15621)
About The Position
We are seeking an Associate Scientist to support technical transfer and lifecycle-management activities for commercial drug product fill-finish processes. The individual will support transfers between development and manufacturing sites and will work closely with Process Development, Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other cross-functional partners. The role will emphasize preparation and review of technical transfer documentation, study protocols, reports, process assessments, product impact assessments, and regulatory-support documents. The candidate will also support process characterization and laboratory-based activities as needed. The successful candidate will have a strong understanding of end-to-end drug product manufacturing, including formulation, mixing, hold operations, sterile filtration, filling, lyophilization, and product-contact systems. Time will be divided between supporting laboratory and process-development activities and developing clear, scientifically rigorous technical documentation. The ideal candidate will have at least 3 years of drug product process development, manufacturing support, or technical transfer experience in the pharmaceutical or biotechnology industry. Candidates may come from a scientific or engineering background and may have held previous titles such as Associate Scientist, Scientist, or Engineer. This role will have a strong focus on technical transfer documentation, data evaluation, and cross-functional project support. The candidate must also have sufficient hands-on laboratory and drug product process experience to understand the underlying science, critically evaluate study results, and develop technically sound documentation.
Requirements
- At least 3 years of drug product process development, manufacturing support, or technical transfer experience in the pharmaceutical or biotechnology industry.
- Strong understanding of end-to-end drug product manufacturing, including formulation, mixing, hold operations, sterile filtration, filling, lyophilization, and product-contact systems.
- Sufficient hands-on laboratory and drug product process experience to understand the underlying science, critically evaluate study results, and develop technically sound documentation.
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
Nice To Haves
- Previous client or pharmaceutical industry experience is preferred.
- Experience supporting intravenous bag preparation, compatibility, or administration-system studies is a plus.
Responsibilities
- Author, data-verify, and review technical transfer documents, study protocols, technical reports, product impact assessments, data summaries, and regulatory-support documentation.
- Compile, analyze, and interpret development and manufacturing data to support technical transfer, process characterization, validation, and regulatory filings.
- Execute laboratory analytical testing, including viscosity, protein concentration, pH, osmolality, and other relevant product-quality measurements.
- Execute laboratory experiments involving pipetting, formulation, mixing, filtration, sampling, and product-contact evaluations.
- Provide technical support for drug product fill-finish processes, including formulation, mixing, filtration, and filling of vials, syringes, devices, and other parenteral presentations.
- Assist with the development and characterization of drug product processes and transfer of technologies between development and commercial sterile fill-finish sites.
- Support commercial drug product activities involving sterile processing, process characterization, technical transfer, validation, and lifecycle management.
- Evaluate site-to-site differences in equipment, materials, scale, process parameters, and manufacturing procedures.
- Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other support functions to advance technical transfer and commercial manufacturing activities.
- Participate in global cross-functional teams and work effectively within a highly matrixed environment.
- Troubleshoot drug product processing technologies and equipment using data-driven analyses and visualizations to identify root causes and recommend solutions.
- Support product-contact, IV bag, compatibility, or administration-system studies, as needed.
- Assist with transfer readiness, site assessments, comparability evaluations, and validation support.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
