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PDS Tech Inc QC Scientist in Lexington, Massachusetts

PDS Tech is seeking candidates for a QC Scientist position.

How will you make an impact?

This position will work in the GMP compliant QC Laboratories to qualify and conduct chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Supports analytical test method validation and transfer activities at and between external sites for qPCR and ddPCR. Will perform routine assays and testing including SDS PAGE, Elisa, Appearance, qPCR and ddPCR. Responsible for coordinating or contributing to complex projects of moderate scope within QC and cross-functionally. Independently manages analytical reference standard programs for commercial drug substances and drug products including qualification /requalification, inventory, supply / shipping.

What will you do?

  • Independently applies scientific judgment and contribute to milestones related to specific projects.

  • Represents QC business processes and needs within the department and at cross functional forums.

  • Applies knowledge and in-depth understanding of analytical techniques within and outside of their specific group.

  • Resolves technical and tactical operations problems, communicates to stakeholders in a timely manner.

  • Ensures sample testing deadlines are met and tracks due dates through completion to meet or exceed metrics

  • Ensures method performance and sample data trending is kept up to date

  • Maintains cGMP compliance within their laboratories

  • Generates, revises, and/or approves SOP or test methods

  • Reviews and ensures training requirements are completed and maintained for analysts and self

  • Maintains a safe working environment in the laboratory and participates in safety and compliance inspections

  • Supports regulatory inspections and audits

  • Provides frequent overall departmental feedback to senior management.

  • Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).

  • Completes tasks where judgment is required in resolving problems & making recommendations.

  • Proactively participates in the planning and prioritization of multiple projects and/or the resolution of quality and compliance issues.

  • Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System.

  • Independently executes activities without supervisor guidance.

  • Leads and coordinates projects with other departments /vendors.

  • Recognized as a technical expert. Demonstrates an understanding of how method performance impacts the business over time.

Education

Requires BS degree in Chemistry, Biology or other related scientific discipline.

Experience

At least 5-7 years’ experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment.

Knowledge, Skills, Abilities

  • Applied knowledge and in-depth understanding of GMP Quality Control systems

  • It is preferred the candidate have analytical experience with PCR, SDS Page and USP Compendia methods.

  • Demonstrated problem solving ability, interpersonal, oral and written communication skills

  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

  • Contribute to a team based, collaborative environment promoting candor, clarity of purpose and high commitment to business goals.

  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.

  • Completes tasks where judgment is required in resolving problems and recommendations.

  • Understanding of applicable regulatory requirements.

  • Must be proactive, action oriented and have the ability to adapt to a change.

  • Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.

  • Significant laboratory documentation review and revision experience.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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