Scientist I - Process Development

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 70,000 - 95,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Bedford, NH is seeking a Scientist I for Process Development to support formulation and process design in a fast-paced CDMO environment.

You will assist senior scientists on experiments, contribute to technology transfer, and ensure in-process and finished product testing using HPLC/UPLC, UV-Vis, and other assays while maintaining equipment and documentation standards.

Qualifications

• Requires strong lab and wet chemistry skills with attention to detail.
• Knowledge of cGMP, regulatory guidelines, aseptic manufacturing.
• Ability to draft SOPs, batch records and reports with accuracy.

Responsibilities

• Support Process Development projects as SME for formulation and process design.
• Assist in scale-up or manufacturing transitions and tech transfer.
• Collaborate with QC, MTS and Operations, and client teams.

Skills

Wet chemistry

cGMP knowledge

Experimental design

Cross-functional collaboration

Communication

Education

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

Tools

HPLC/UPLC

UV-Vis spectroscopy

Flowcam

Karl Fischer titration

DSC/FDM

Empower

Job description

## Scientist I - Process DevelopmentApply: Bedford, NH, USA: Full time: Posted Today: JR119742Life 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.#LI-AK2