Frontage Laboratories, Inc

Manager/Senior Manager, BGC Operations

Frontage Laboratories, Inc

full-time

Posted on:

Location Type: Office

Location: Exton • Pennsylvania • United States

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Job Level

Senior

About the role

  • Lead and oversee QC activities supporting biologics and gene therapy programs in all phases
  • Lead method development, qualification, validation, verification, and transfer
  • Author/review/approve validation protocols, reports, and analytical data packages
  • Oversee deviations, OOS/OOT, CAPAs, change control, and data integrity investigations
  • Support regulatory inspections and client audits as CMC QC subject matter expert
  • Train and develop staff scientists
  • Manage budgets and balance resource allocation to meet project priorities.
  • Closely interact with clients through various means of communication and ensure client satisfaction.

Requirements

  • More than six years of experience in GMP testing and analytical development for biologics and/or gene therapy products.
  • Expertise in at least one of technical areas, such as binding assay (ELISA, SPR, BLI, etc.), potency assay (cell based), molecular biology (qPCR and dPCR), and separation sciences (RP-HPLC, HIC, HILIC, SE-HPLC, IEX, icIEF, and CE-SDS, etc.)
  • Knowledge of general GMP laboratory operations, method transfer, qualification, and validation.
  • Knowledge of FDA, EU, USP, ICH guidelines and regulations
  • Excellent communication skills for liaising and communicating with vendors, customers, and internal departments.
  • Able to quickly assess compliance risk of events and make decisions that are scientifically sound and compliant with the regulations.
  • Ability to collaborate effectively in a dynamic and cross-functional matrix environment.
  • Experience with ZENQMS and laboratory information systems, such as NuGenesis, is plus.
Benefits
  • health and dental insurance
  • 401(k) plan
  • disability insurance
  • life insurance
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP testinganalytical developmentbinding assaypotency assaymolecular biologyseparation sciencesmethod transferqualificationvalidationdata integrity
Soft Skills
communication skillscollaborationclient satisfactionstaff trainingresource allocationdecision makingrisk assessment