Scientist I, QC Analytical(2nd Shift)

Forge Biologics•Columbus, OH

1d•Onsite

About The Position

The Scientist I, Quality Control (Analytical) role will primarily focus on analytical method execution, method qualification, method validation, and troubleshooting efforts. This position will be responsible for executing in-process, final product, and stability testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner. This position will also be responsible for fostering innovation within the QC department, either independently or by partnering with Analytical Development, ensuring cutting-edge technologies are employed to maintain the highest QC standards in the analysis of gene therapy products. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

Requirements

Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology). Advanced degree preferred.
Experience in either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC) based on experience.
Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays).
Proven ability to execute, troubleshoot, and optimize analytical assays.
Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.
Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.
Experience in leading, mentoring, and guiding junior team members.
Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.

Responsibilities

Perform in-process, release, and stability testing for assays relevant to viral vector/gene therapy products, plasmids, and cell banks, including in-process testing, lot release testing, assay qualification, and validations.
Perform either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC) at a high level.
Additionally, perform advanced analytical testing quality control assays, including cell-based infectivity assays, potency assays, qPCR, ELISA, and viability assays, to assess the quality, potency, and safety of AAV vector products.
Support troubleshooting of processes/assays.
Represent QC during audits and inspections from bench level as needed.
Ensure effective qualifications, validations, and transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
Contribute to authoring and/or reviewing QC documentation, including but not limited to: SOPs, analytical methods and forms, qualifications protocols, and validation protocols.
Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
Provide support for Deviations, Change Controls, and CAPAs related to in process and final product testing.
Review and approve GMP documentation associated with in process, final product, and stability testing.
Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.
Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
Support regulatory and client inspections and internal audits of GMP systems.
Manage tracking and trending of in process and final product testing data, including, but not limited to; leading/ participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.