Scientist I - Process Development

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

PCI Pharma Services is seeking a Scientist I to support the Process Development department in a fast-paced CDMO environment. The role involves extensive laboratory work, testing, and collaboration with client teams to advance pharmaceutical development projects.

The ideal candidate will have a strong wet chemistry background, knowledge of cGMP, and experience documenting batch records and SOPs while coordinating with QC, MTS, and operations to meet project milestones.

Qualifications

• BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field (0–5 years’ pharma development).
• Proficient laboratory and wet chemistry skills.
• Knowledge of cGMP and regulatory guidelines.
• Experience documenting batch records, SOPs, and reports.

Responsibilities

• Support Process Development projects as SME for formulation and process design.
• Assist senior scientists to perform experiments and meet milestones.
• Represent PD on internal/client calls with technical updates.
• Support formulation design, sterile filtration, lyophilization, and ADC-related work.
• Assist in technology transfer and scale-up activities.
• Execute in-process and finished product testing using HPLC/UPLC, UV-Vis, DSC, and related assays.
• Maintain equipment calibration, cleanliness, and facilities upkeep.
• Draft and review batch records, protocols, and reports for quality compliance.
• Collaborate with QC, MTS, Operations, and external client teams.

Skills

Laboratory skills

Wet chemistry

Written/oral communication

Project coordination

Education

BS/MS in Chemical Engineering / Pharma sciences

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 SUMMARY

The Scientist I position supports the efforts of the Process Development department within a fast-paced, expanding CDMO. This job will require extensive laboratory work, testing, and strategic client support of pharmaceutical development projects.

JOB DUTIES

• Support Process Development projects, serving as a SME and collaborator for formulation and process design activities.
• Support senior scientists in performing experiments to achieve project milestones.
• Act as a Process Development representative on internal and client-facing project calls, providing technical updates and strategic input.
• Support the formulation design, sterile filtration, lyophilization, and post-processing for both small molecules and biologics, including antibody-drug conjugates (ADCs) and other complex modalities.
• Support technology transfer activities and assist in scale-up or manufacturing transitions.
• Executor of in-process and finished product testing within the Process Development laboratory, utilizing methods such as HPLC/UPLC, UV-Vis spectroscopy, Flowcam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria.
• Ensure proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.
• Perform or assist in routine facilities cleaning and equipment upkeep as required.
• Draft and review Process Development batch records, protocols, and reports to ensure technical accuracy and compliance with internal quality standards.
• Draft and maintain Standard Operating Procedures (SOPs) and related controlled documents for Process Development operations.
• 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 proficient 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.
• Works independently with little direction; demonstrates a proven track record of leading tasks to completion.
• 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

• BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-5 years' experience in pharmaceutical development or CDMO industry
• A desire to work in clinical-phase development and analytical characterization of drug products, including biologics
• 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.