Frontage Laboratories, Inc

Manager/Senior Manager, BGC Operations

Frontage Laboratories, Inc

full-time

Posted on:

Location Type: Office

Location: Exton • Pennsylvania • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

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
GMP testinganalytical developmentbinding assaypotency assaymolecular biologyseparation sciencesmethod transferqualificationvalidationdata integrity
Soft skills
communication skillscollaborationclient satisfactionstaff trainingresource allocationdecision makingrisk assessment