Senior Manager, Analytical Development

CG Oncology

8h•Remote

About The Position

The incumbent will lead projects or act as a subject matter expert (SME) under minimal supervision focused on the late-stage and commercial development, validation, and optimization of analytical methods required for release and characterization of cGMP live viral drug products at contract laboratories. The primary focus will be development of second-generation release and stability methods but will also include a wide variety of analytical characterization methods such as liquid chromatography and AF4, mass spectrometry, viral cytometry, capillary electrophoresis, and deep sequencing. In addition, the individual will be responsible for developing and overseeing the execution of viral and excipient study protocols to support product licensure, analytical transfers, and troubleshooting at a wide range of external contract vendors. Location: Remote

Requirements

BS, MS, or PhD in physical, chemical, biological, or pharmaceutical science with the associate years of analytical development and validation experience level as noted below.
BS plus eight (8) years of experience, or MS plus six (6) years of experience, or PhD plus three (3) years of experience.
Experience with analytical development and qualification/validation of biologics, especially live viral products.
Experience with late-Phase and commercial bio-analytics.
Knowledge of OFAT, DOE, and other study design methodologies including experience with statistical analyses
Familiarity with current GMP regulations is required.

Responsibilities

Manages, oversees, helps design and review method transfer, method development, and validation of release and stability-indicating methods for live viral drug products and assists in the development of analytical validation and verification protocols and associated reports with external contract and consulting SMEs.
Mentors and trains others on a wide variety of analytical techniques including, but not necessarily limited to cell-based bioassays, viral titer assays, ELISA, dd/qPCR methods, deep sequencing, high- performance liquid chromatography (HPLC/UPLC), mass spectrometry, UV/Vis spectroscopy, and other general molecular biology, virology and cell culture methods.
Troubleshoots and optimizes analytical methods for the characterization of drug products, standards, and process intermediates. Designs qualification/validation and bridging/comparability studies for product characterization, process clearance, and stability assessments.
Conducts data analytics, including retrospective data collection and statistical analyses, to support method development, troubleshooting, investigations, and validation efforts.
Communicates results both internally and externally through oral and written updates, presentations, and formal reports, as necessary. Lead discussions with contractors and clients on technical topics relating to their projects as needed. Acts as key technical point-of-contact (SME) for work under their supervision.
Exercises technical discretion and critical thinking in the design and interpretation of experiments and experimental reports independently without direct supervisory assistance or guidance.
Creates and/or revises new department-wide and site-wide procedures and company policy SOPs.
Collaborates with Quality Assurance, Quality Control, and Regulatory Affairs on analytical method and report reviews, validation, and regulatory submission & compliance issues. Familiarity with current GMP regulations is required.
Stays abreast of current scientific technologies and regulations related to the manufacture and characterization of live viral products, vaccines, and biologics.
Proactively communicates strategy to the Analytical/QA teams and work closely with contractors to generate new proposals, work scopes, or change orders, as appropriate.
Will support the business aspects of their position by working with their supervisor to review billing/invoicing communications for all work under their supervision.
Generates and reviews regulatory and client-requested documentation for CMC analytics and product characterization.
Conducts routine release and stability test report reviews and leads out-of-specification (OOS), out of-trend, and other event investigations, as needed.