Scientist I - Process Development

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

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.

Requirements

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
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.

Nice To Haves

Experience with MS Office (Word/Excel/Teams/PowerPoint/SharePoint), SmartSheets, LabX, and Empower

Responsibilities

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