Senior Director/Vice President Process Engineering

Position Overview

The position will report directly to the EVP of Pharmaceutical Development and be responsible for leading and establishing Decibel’s gene therapy process development. The candidate will work closely with cross-functional leaders, R&D project teams and with external CROs and CDMOs to establish gene therapy manufacturing processes and manufacture high quality products in support of Decibel’s R&D product pipeline, preclinical through all phases of clinical development.

The ideal applicant will be an experienced process engineer/scientist with a strong background AAV viral vector production and associated analytics. The applicant will have a demonstrated record of successfully leading groups of scientists and engineers to develop processes for the manufacture of adeno-associated virus (AAV) based gene therapies. The position will focus on developing and implementing processes for the production of high quality AAV for use in non-clinical, clinical studies, and registration

Primary responsibilities are to lead and oversee the development of all external end to end upstream and downstream processes and unit operations and effectively communicate overall progress and results to project teams and senior management.

Responsibilities:

• Define process development strategy and implement for cGMP production of high quality gene therapy vectors with robust and stage appropriate unit operations
• Provide technical leadership and development of effective upstream and downstream processes and quality cGMP manufacturing
• Management and technical oversight of manufacturing processes and campaigns at the CDMOs of stage appropriate material to support pre-clinical and clinical studies
• Lead studies for process development and production of vector, including strategies for screening, optimization and scale-up, as part of a comprehensive strategy to establish robust, processes, including process validation, utilizing DoE (Design of Experiments), and QbD (Quality by Design)
• Ensure products meet or exceed required quality standards per current regulatory guidance
• Prepare and present results and progress of process development studies
• Write, review and/or finalize technical reports, SOPs, tech transfer documents and Quality sections of Regulatory Filings
• Stay current with and implement best practices to develop and establish cost effective, operations, that are stage appropriate, robust and scalable.
• Collaborate and develop relationships that build trust and respect at operational and strategic level across the organization as well as with CDMOs
• Serves as the cross functional representative and provides program-specific leadership and subject matter expertise for process development activities
• Supports PharmDev/CMC senior management team in operational planning, including prioritizing projects to ensure alignment with Decibel’s corporate goals and objectives

Requirements

This position requires a Minimum of a B.S., M.S. or PhD in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry) and 10+ years of relevant industry experience in bioprocessing. Experience should include:

• Demonstrated manufacturing experience and expertise with AAV or Viral Vector process development and cGMP manufacturing is required
• Experience managing with Contract Manufacturers (CMOs), and experience in successful technology transfer of biotherapeutics to cGMP Manufacturing facilities
• Leader with an in-depth understanding of methodology required for scale-up and process development strategies of mammalian cell culture systems for the production of viral vectors for clinical or commercial use
• Strong background and technical expertise with development and scale-up of purification processes for AAV and/or other viral vectors, or vaccines
• Understanding of analytical methods used to support process development and QC of viral vector products is required.
• History of developing analytical assays suitable for supporting process development of biotherapeutics a plus.
• Understanding and application of engineering principles and experimental design, significant experience applying this toward development of manufacturing processes of biotherapeutics (QbD, and DoE) to efficiently plan process development, optimization to provide statistically meaningful outputs.
• Well versed in current cGMP and GLP Regulatory Guidelines and requirements related to pharmaceutical development, process validation for AAV-based gene therapy, with expertise for working within aseptic cGMP compliant environments
• Experience in process validation or recent experience with late-stage development of biologics or viral vector products, with familiarity in establishing a risk-based approach to BLA-enabling studies a plus
• Highly motivated, and demonstrates strong technical leadership skills, has excellent organizational and communication skills, and ability to execute successfully
• Detail oriented and strong track record of success
• Ability to think strategically and drive appropriate decisions
• Team leadership experience
• Experience with writing regulatory submissions, process reports and technical transfer documents
• Excellent computer skills
• Decibel Therapeutics, Inc. is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.