Scientist II PharmDev Analytical

## Scientist II Pharm Dev Analytical Apply locations:
Bedford, NH, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR116482

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.
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* 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, Flow Cam, 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.##
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* Qualifications:

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* ** 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), Smart Sheets, 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-AK2

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