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PCI
Bedford, NH, USA; USA_NH_Bedford_23Com
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
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.
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.
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.
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