## Scientist II PharmDev AnalyticalApplylocations: Bedford, NH, USAtime type: Full timeposted on: Posted Todayjob requisition id: 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.**Summary of Objective:**The Scientist II position is a key collaborator of the Analytical Development team in Pharmaceutical Development department within a fast-paced, expanding CDMO. This job will require both support and leadership in hands-on experimentation, testing, and strategic project management to support clients.**Essential Duties and Responsibilities:*** Leads Analytical Development activities to support projects for various modalities, serving as the technical lead and SME for analytical methods development and testing.* Supports more complex formulation and process development projects as an Analytical Development SME, working with a senior scientist to achieve project milestones.* Executes method development and transfer to achieve project milestones without supervision.* Develops and implements phase-appropriate analytical method development strategies aligned with program objectives and regulatory expectations.* Acts as an Analytical Development representative on internal and client-facing project calls, providing technical updates and strategic input.* Demonstrates proficiency in method development for both small molecules and biologics, analytical data interpretation and trending.* Develops and optimizes analytical methods to support formulations development for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities.* Drives analytical methods transfer activities to QC and provides supports in scale-up or manufacturing process transitions as an analytical development SME.* Performs analytical testing within Pharmaceutical Development laboratory to support formulation and process development, such as HPLC/UPLC, Capillary Electrophoresis, UV-Vis spectroscopy, FlowCam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria as part of formulation development activities.* Provides training on analytical methods execution for formulation and process development scientists.* Troubleshoots analytical methods challenges and proposes scientifically sound corrective actions.* Responsible for proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.* Performs or assists in routine facilities cleaning and equipment upkeep as required.* Authors and reviews Analytical Development records, protocols, and reports to ensure technical accuracy and compliance with quality standards and client demand.* Reviews executed documentation for accuracy and completeness prior to submission to management.* Drafts and maintains Standard Operating Procedures (SOPs) and related controlled documents for Pharmaceutical Development operations.* Provides technical guidance and mentorship to junior scientists and laboratory staff.* Drives analytical methods transfer activities to QC and provides supports in scale-up or manufacturing process transitions as an analytical development SME.## **Qualifications:** **EDUCATION/EXPERIENCE:*** Advanced Degree in (PhD) in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or other related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry.* MS/BS in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, Biochemistry, or other related fields with 3/5+ 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, analytical methods development for small and large molecules.* 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 balance with independent thinking* Resilient through operational and organizational change#LI-AK2Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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