Process Development Lead – Formulation & Biologics

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 110,000 - 165,000; Full time

Job summary

PCI Pharma Services is seeking a Process Development Scientist to lead and mentor on formulation and process design for small molecules and biologics, including high-potency compounds and ADCs. You will interact with internal QC, MTS, and Operations teams and guide junior scientists through complex projects.

The role requires advanced degrees with extensive experience in regulatory-guided development and technology transfer, and proficiency in analytical methods and lyophilization.

Qualifications

• Advanced Degree in (PhD) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry.
• BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 5+ years’ experience in pharmaceutical development or CDMO industry.
• A strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and other complex modalities.
• In depth knowledge of biopharmaceutical and/or medical product regulation, formulation, filtration, filling, and lyophilization operations.
• Experience with MS Office (Word/Excel/Teams/PowerPoint/SharePoint), SmartSheets, LabX, and Empower

Responsibilities

• Lead Process Development projects, serving as the technical lead and SME for formulation and process design activities.
• Supports more complex Process Development projects as a collaborator, working with a senior scientist to achieve project milestones
• Execute and analyze experiments to achieve project milestones with minimal supervision.
• Develop and implement phase-appropriate process development strategies aligned with program objectives and regulatory expectations.
• Act as a Process Development representative on internal and client-facing project calls, providing technical updates and strategic input.
• Demonstrate proficiency in formulation design, sterile filtration, lyophilization, and post-processing for both small molecules and biologics.
• Develop and optimize processes for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities.
• Support technology transfer activities and assist in scale-up or manufacturing transitions.
• Perform in-process and finished product testing within the Process Development laboratory, such as HPLC/UPLC, UV-Vis spectroscopy, Flowcam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria.
• Troubleshoot analytical or process challenges and propose scientifically sound corrective actions.
• Responsible for proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.
• Perform or assist in routine facilities cleaning and equipment upkeep as required.
• Author and review Process Development batch records, protocols, and reports to ensure technical accuracy and compliance with quality standards and client demand.
• Review executed documentation for accuracy and completeness prior to submission to management.
• Draft and maintain Standard Operating Procedures (SOPs) and related controlled documents for Process Development operations.
• Provide training, technical guidance, and mentorship to junior scientists and laboratory staff.
• Collaborate cross-functionally with internal stakeholders including Quality Control (QC), Manufacturing Technical Services (MTS), and Operations, as well as external client teams, to ensure alignment and successful project execution.

Skills

Lab skills

Wet chemistry

cGMP

Regulatory guidelines

Aseptic manufacturing

Lyophilization

Education

PhD in Chemical Engineering

BS/MS in Chemical Engineering/Pharmaceutical Sciences/Chemistry/Biochemistry

Tools

MS Office

SmartSheets

LabX

Empower

Job description

PCI Pharma Services is seeking a Process Development Scientist to lead and mentor on formulation and process design for small molecules and biologics, including high-potency compounds and ADCs. You will interact with internal QC, MTS, and Operations teams and guide junior scientists through complex projects.

The role requires advanced degrees with extensive experience in regulatory-guided development and technology transfer, and proficiency in analytical methods and lyophilization.