Scientist II - Process Development

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

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.

JOB DUTIES

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/goggles, gloves and safety shoes. Ability to gown and gain entry to controlled manufacturing areas. Ability to lift, pull or push equipment requiring up to 25-50 lbs of force Ability to stand for prolong periods in a production suite and work extended hours.

COMMUNICATIONS & CONTACTS

Works directly with Process Development personnel Works closely with QCAD, VAL, MTS, and Operations Will interact with Customers on a regular basis

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

Required to lead and train junior level Process Development Scientists positions.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.