Lead Process Development Scientist: Formulation & Biologics

pciservices; Bedford (NH); On-site; USD 90,000 - 140,000; Full time

Job summary

PCI is seeking a skilled Process Development Scientist to lead formulation and process design efforts for small molecules, biologics, and high-potency compounds. You will work with senior scientists to achieve milestones, analyze experiments, and drive strategies that meet program objectives and regulatory expectations.

The role emphasizes collaboration with QC, MTS, and Operations, with hands-on lab work in analytical testing, formulation, lyophilization, and scale-up activities.

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.
• 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.
• 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

Laboratory skills

cGMP knowledge

Aseptic Manufacturing

Independent worker

Communication skills

Education

PhD in Chemical Engineering or related

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

Tools

MS Office

SmartSheets

LabX

Empower

Job description

PCI is seeking a skilled Process Development Scientist to lead formulation and process design efforts for small molecules, biologics, and high-potency compounds. You will work with senior scientists to achieve milestones, analyze experiments, and drive strategies that meet program objectives and regulatory expectations.

The role emphasizes collaboration with QC, MTS, and Operations, with hands-on lab work in analytical testing, formulation, lyophilization, and scale-up activities.