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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

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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 are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.