Scientist II PharmDev Analytical

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 90,000 - 120,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd is seeking a Scientist II for Analytical Development in Bedford, NH. The role leads analytical method development, supports formulation projects, and serves as technical SME for complex modalities including ADCs and biologics.

You will develop and transfer analytical methods, collaborate on project calls, train junior staff, and ensure data integrity and regulatory readiness across programs in a fast-paced CDMO environment.

Qualifications

• Advanced degree with 0–3 years’ experience or MS/BS with 3–5+ years in pharmaceutical development.
• Strong foundation in analytical methods development for small molecules and biologics.
• Experience with MS Office, data analysis, and regulatory expectations.
• Knowledge of biopharmaceuticals, ADCs, and QC transfer processes.

Responsibilities

• Lead Analytical Development activities to support projects as SME for methods development and testing.
• Support formulation and process development projects as an SME with senior scientist guidance.
• Execute method development and transfers to achieve milestones without supervision.
• Develop strategies aligned with program objectives and regulatory expectations.
• Act as a representative on internal and client calls, providing updates and input.
• Demonstrate proficiency in method development for small molecules and biologics.
• Develop and optimize analytical methods for high-potency compounds and ADCs.
• Drive transfer activities to QC and support scale-up or manufacturing transitions.
• Perform analytical testing (HPLC/UPLC, CE, UV-Vis, DSC, etc.) to meet acceptance criteria.
• Provide training on analytical methods to junior scientists and staff.
• Troubleshoot method challenges and implement corrective actions.
• Maintain instruments, calibrations, and clean facilities; draft SOPs and reports.

Skills

MS Office

LabX

Empower

SmartSheets

Education

PhD in Pharmaceutical Sciences

MS/BS in Pharmaceutical Sciences

Job description

## Scientist II PharmDev AnalyticalApplylocations: Bedford, NH, USAtime type: Full timeposted on: Posted Todayjob requisition id: JR116482Life 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