Scientist II PharmDev Analytical

pciservices; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in the United States is seeking a Scientist II to join the Analytical Development team within Pharmaceutical Development. The role requires hands‑on experimentation, leadership, and strategic project management to support clients.

You will lead method development, oversee transfers, and collaborate with cross‑functional teams to advance formulations and manufacturing processes for complex modalities including biologics. Strong communication and mentoring skills are essential.

Qualifications

• Advanced degree with 0–3 years' pharmaceutical development/CDMO experience.
• MS/BS with 3–5+ years' pharmaceutical development or CDMO experience.
• Strong knowledge of biopharmaceutical regulation and analytical characterization.
• Experience with analytical software and Office tools.

Responsibilities

• Lead Analytical Development activities as technical lead and SME.
• Support formulation and process development with senior scientist guidance.
• Execute method development and transfer to QC and manufacturing teams.
• Develop phase-appropriate analytical strategies aligned with program goals.
• Represent Analytical Development on client calls with updates and input.
• Train junior scientists on analytical methods execution.
• Draft and maintain SOPs and controlled documents.

Skills

Analytical method development

Analytical data interpretation

Method transfer

HPLC/UPLC operation

Troubleshooting

Mentorship

Cross-functional communication

Education

Advanced Degree in Pharmaceutical Sciences/related field

MS/BS in Pharmaceutical Sciences/related field

Tools

MS Office (Word/Excel/Teams/PowerPoint/SharePoint)

SmartSheets

LabX

Empower

Job description

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 Fisher 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

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion