Process Development Scientist I – Formulations & Biologics

PCI Pharma Services; Tennessee; On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Tennessee seeks a Scientist I to support the Process Development team in a fast-paced CDMO. The role involves extensive lab work, method development, and collaboration with clients to advance pharmaceutical projects from early stages to scalable processes.

The candidate will assist with formulation, analytical testing (HPLC/UPLC, UV-Vis), technology transfer, and batch record documentation, while upholding cGMP and quality standards in a dynamic, cross-functional

Qualifications

• BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with 0–5 years’ pharma development/CDMO experience.
• Knowledge of cGMP, regulatory guidelines, aseptic manufacturing, and bulk intermediate/medical device manufacturing.
• Ability to work independently and lead tasks to completion.
• Strong interpersonal skills and ability to communicate project updates clearly to clients and internal teams.

Responsibilities

• Support Process Development projects as SME and collaborator for formulation and process design activities.
• Assist senior scientists in experiments to achieve project milestones.
• Represent Process Development on internal and client calls with technical updates and input.
• Support formulation design, sterile filtration, lyophilization, and post-processing for small molecules and biologics, including ADCs.
• Assist tech transfer activities and scale-up/manufacturing transitions.
• Perform in-process and finished product testing using HPLC/UPLC, UV-Vis, Flowcam, Karl Fischer, DSC/FDM and related assays to confirm acceptance criteria.
• Maintain laboratory instruments and ensure calibration/cleanliness.
• Draft/review batch records, protocols, and reports with compliance to quality standards.
• Draft and maintain SOPs for Process Development operations.
• Collaborate with QC, MTS, Operations, and external client teams to ensure project success.

Skills

Wet chemistry

cGMP knowledge

Independent worker

Communication skills

Education

BS/MS in Chemical Engineering or related

Tools

LabX

Empower

MS Office Suite

Job description

PCI Pharma Services in Tennessee seeks a Scientist I to support the Process Development team in a fast-paced CDMO. The role involves extensive lab work, method development, and collaboration with clients to advance pharmaceutical projects from early stages to scalable processes.

The candidate will assist with formulation, analytical testing (HPLC/UPLC, UV-Vis), technology transfer, and batch record documentation, while upholding cGMP and quality standards in a dynamic, cross-functional