Scientist II - Process Development

## Scientist II - Process Development Apply:
Bedford, NH, USA:
Full time:
Posted Today:
JR119743

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,…