Scientist II - Process Development

About the role

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

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.

Professional Skills

• Requires exemplary laboratory and wet chemistry skills
• Knowledge of current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing.
• Experience with lyophilization cycle design preferred.
• Works independently with little direction; demonstrates a proven track record of leading tasks to completion.
• Ability to learn new technologies and concepts and drive implementation in the laboratory
• Must consistently exhibit positive, effective interpersonal skills with internal and external teams, including relationship management of clients.
• Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
• Demonstrates excellent oral and written communication skills, and can provide detailed project updates (PowerPoint) to clients and other internal departments efficiently and concisely.
• Requires excellent organizational and interpersonal skills, team-player

Education/Experience

• 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

Qualities

• Detail oriented and a results driven team player
• Ability to work in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Creative with the ability to work with minimal supervision and balanced with independent thinking
• Resilient through operational and organizational change

Physical Requirements

• Ability to wear personal protective equipment such as safety glasses/gogg