Head of Analytical Development and Quality Control

VintaBio is a technology company focused on simplifying viral vector production. Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. Our research core produces high-yield and world-class POC vectors. Through a comprehensive production workflow that utilizes VintaBio's proprietary cell lines and transfection reagents, we expedite the path to the clinic, offer more reliable manufacturing, and improve economics.

Position Summary

The Head of Analytical Development and Quality Control leads and oversees the development, qualification, validation, and implementation of analytical methods and quality control processes for the organization and clients. These analytical methods are utilized for in-process controls, material/product release and stability assessments. This individual will ensure all activities align with regulatory requirements and standards, support product development and cGMP manufacturing, and maintain product quality standards. The leader maintains connections to international guidance and standard bodies to ensure VintaBio remains at the forefront of accepted practices and technology. This leader will oversee the functional organization, hiring and development, as well as planning and execution of laboratory activities, including sample management. The successful candidate will also be an active member of project teams including Client projects.

Key Responsibilities

Analytical Development

• Lead the design, development, and optimization of robust and reliable methods and specifications for in-process controls, material/product release, and stability assessments to support the product development life cycle while considering economic, regulatory and safety factors.
• Ensure methods are developed in compliance with regulatory standards and guidelines.
• Lead phase-appropriate analytical method implementation, qualification, and validation for raw materials, viral vectors and cell lines.
• Responsible for experimental/project execution and summary reports.
• Collaborate with cross-functional teams to support product development.
• Participate in and, at times, lead data mining to enhance analytical and process optimization of VintaProcess™

Operational Management

• Lead and mentor a team of scientists and quality control specialists while fostering a culture of rigor and continuous improvement.
• Responsible for ensuring employees are trained on SOPs, equipment, all unit operations and other relevant non-QC SOPs and systems with a focus on data integrity.
• Develop and maintain GxP compliant processes, documentation, and systems that are utilized by the team in executing daily responsibilities.
• Support regulatory submissions both internally and for Clients including INDs, as well as regulatory inspections and audits.
• Provide hands-on technical leadership in the laboratory.
• Contribute to scientific literature and conferences while staying current with advancements in analytical technologies and regulatory trends.

Quality Control

• Manage quality control activities including routine raw material testing, in-process testing, stability studies, and release testing of products.
• Ensure QC operations are compliant with cGMP and other applicable regulations.
• Address and resolve quality issues, deviations and non-conformances.
• Oversight of cGMP activities to support manufacturing operations, e.g. gown qualification, environmental monitoring, area cleaning.

External Engagement

• Act as primary contact for Client Analytical requirements including methods, sampling plans, and stability studies.
• Align with Client on audit strategy, plan, and execution for analytical and sterility-focused audit activities.
• Oversee 3rd party testing organizations executing analytical methods including sourcing, qualifying and managing the labs to support VintaBio process development and production testing needs.

Education and Experience

• Education: Bachelor’s degree in a relevant field (e.g., Chemistry, Analytical Chemistry, Biochemistry, or Biology); advanced degree with focus on Analytical (MBA, MSA, PhD) preferred.
• Experience: Minimum of 10 years of experience, with at least 5 years in a leadership role within the biopharmaceutical or gene therapy industry.
• Working knowledge of methods and assays including (d)dPCR, qPCR, ELISA, TCID50 and rcAAV.

Knowledge, Skills and Abilities

• Knowledge of GLP, cGMP, GxPs and regulatory requirements is required.
• Deep understanding of analytical method development, qualification, validation, and transfer.
• Strong communication and interpersonal skills to effectively interact with internal teams, regulatory agencies and external partners.
• Excellent problem solving and decision-making abilities.
• Demonstrated experience with risk management
• Proven ability to work in a lean organization and creatively tackle problems.
• Able to work independently in a matrix environment and manage multiple tasks simultaneously.

Physical Requirements

• Ability to lift and carry up to 10 lbs.
• Ability to sit and stand for extended periods

Position Type: Full Time, Exempt

Travel: Occasional (0-10%)

Work Environment: Work is performed primarily onsite in Philadelphia, PA