About this opportunity
PCI TRGR Penn Pharmaceutical Services Ltd lists this Scientist II - Process Development opportunity in bedford, New Hampshire. Review the employer’s description below for duties, qualifications and application requirements.
Job description
## Scientist II - Process DevelopmentApply: Bedford, NH, USA: Full time: Posted Today: JR 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. #LI-AK2
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Worksite address
bedford, NH, 03110, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.