Senior Manager / Director, Vector Analytical Development & Validation

Lowell, MA     ·      Full time

Job Summary:

Alcyone Therapeutics is developing novel gene therapies based on unique platforms for genetic modification combined with precision dosing and delivery of viral vectors. The company is focusing on neurological disorders, including several orphan indications. The Senior Manager – Director, Vector Analytical Development & Validation will be responsible for oversight of viral vector development, qualification and validation of analytical assays (both internally and through CDMOs), to support vector release for use in clinical studies and commercial use. The Senior Manager – Director, Vector Analytical Development & Validation will be part of a growing department of CMC specialists at Alcyone.

Major Responsibilities and Duties:

The Senior Manager – Director, Vector Analytical Development & Validation will be responsible for planning, organizing and overseeing the analytical development of several gene therapy candidates to enable their cGMP production and commercialization. They will lead and oversee analytical development to deliver optimized characterization and release methods suitable for the cGMP manufacture of recombinant gene therapy vectors and ensure scientific rigor during testing of cGMP material. This individual will work in partnership with internal and external R&D, Manufacturing, process development, QC/QA and regulatory functions to deliver products for clinical and commercial supply and serve as a key technical expert in communications with both internal and external partners including CDMOs. Open, effective, and proactive communication is critical for success in this role. Must have a strong work ethic and be able to work independently with minimal supervision. Must be able to manage remote operations effectively and proactively through CDMOs/CROs. Must be willing to travel with little notice and adhere to site vendor credentialing requirements.

Essential Responsibilities/Functions:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily:

• Lead the development of first-in-class methods in support of R&D, clinical and commercial programs.
• Lead and oversee technology transfer from development to cGMP facilities either internally, CDMOs and at other external partners.
• Work with internal and external groups to apply analytical techniques to understand key product and process attributes.
• Review and provide input for assay qualification and validation efforts primarily at CDMOs/CROs.
• Review and provide input into the development of release and stability specifications.
• Working knowledge of viral vector gene therapy guidances including FDA, EMA and ICH.
• Proficient in Quality control execution and systems, stability study programs for AAV, and end to end CMC regulatory drug approval process for biologic drug products.
• Lead the analytical troubleshooting effort in support of cGMP investigations for OOS or other deviations.
• Work directly with Executive Management to identify, analyze, and communicate new or shifting timelines, including risk mitigation, to the company and its impact on the business.
• Manage and optimize strategies for efficient review, editing and approval of documentation, reports.
• Support drafting of Regulatory filings.
• Identify and incorporate state-of-the-art techniques into product testing.
• Represent assay development and analytics at all project team meetings and work effectively with a cross-functional team to develop a strategic vector manufacturing plan for each program and then be the key person responsible to oversee its day-to-day operational execution.
• Proven strength in technical writing and the successful development and submission of CMC documents to support clinical and/or commercial use of a gene therapy project.
• Actively comply with Alcyone’s Quality System.
• Perform all administrative activities associated with the functional area. This will include supporting the department’s goals and objectives, as well as developing and managing timelines and budgets.
• This position reports to the EVP for Technology Development.

Education/Qualifications:

•  PhD or master’s degree in a science, engineering, or related field or equivalent.
• Minimum of 5+ years’ experience in a biotechnology environment and/or working on AAV viral vector manufacturing to support programs in gene therapy.
• Minimum of 2+ years of experience leading AD or QC organizations
• Experience in all phases of vector analytics including development, qualification/validation, stability, and analytical testing of recombinant AAVs.
• Track record of developing and implementing assays for CMC development of AAV gene therapies.

Skills and Abilities:

The ideal candidate will possess the following skills and abilities:

• Comprehensive knowledge of current GMPs, GLPs and relevant ICH regulations.
• Sound understanding of molecular biology, virology, and cell culture and bio-assays.
• Must be capable of succeeding in a small company setting, effectively managing multiple manufacturing workstreams in a dynamic, virtual environment.
• Successful management of relationships at all levels of the organization.
• Excellent verbal and written communication skills.
• Team-oriented individual with strong interpersonal skills, management, and communication skills in a virtual work environment.
• Solid analytical skills and the ability to problem solve quickly.
• Commitment to company with ability to function within a start-up environment.
• Skilled in Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook) and specialty software.
• Makes good decisions in a timely manner, based upon a mixture of analysis, wisdom, experience, judgment, and direction.

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