Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company's pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson's disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich's ataxia, Huntington's disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer's disease and severe chronic pain.
Voyager is seeking a highly motivated leader to manage its expanding Analytical Development team.
The qualified candidate will be a leader within Voyager Technical Operations with a strong background and expertise in analytical development for biologics or vaccines.
Primary responsibilities will include oversee the scientific development, qualification, transfer and execution of new state-of-the-art analytical methods to be used for release and characterization of Voyager's clinical and commercial products. This individual will also manage the team responsible for process assay support to other Development groups within the company. Ability to lead and provide guidance to a growing team of over 10 scientists is required.
Additionally, the individual will key leader in the writing and review of IND and BLAs.
This position is located in Cambridge, MA, reporting to the Chief Technical Operations Officer.
Voyager is internalizing the scientific development of most critical assays, but externalizes all GMP activities. Thus, the candidate will be required to travel, as needed, to CROs in US or overseas.
Lead overall analytical development and testing project plans for existing and envisioned projects
Develop analytical methodologies and strategies needed to progress products in the pipeline including method development, process support, formulation and stability support, product characterization and method qualifications
Partner with other Technical Operations functions (process development, external manufacturing and Quality) to enable aligned goals and achievement of deliverables
Manage and participate in tech transfer of analytical methods to CMO's/CRO's
As member of CMC team meeting, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired schedule
Coordinate the interaction of the CMC cross-functional projects among Voyager personnel, and between Voyager and the CROs.
Partner with External oversight team and work closely with CROs used to test GMP material, using site visits and frequent communication with CRO team members to update status of projects
Interact with program core teams to ensure alignment of CMC analytical development and testing plan with overall program strategy, and the requirements of pre-clinical and clinical teams
Monitor scope, milestones, dependencies, and costs associated with CRO project and the timelines for CRO deliverables.
Drive projects through project goals to ensure compliance to defined schedule.
Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
Create and maintain comprehensive risk management plan for product testing
Working with the CMC team, provide effective mitigation and escalation strategies for project risks and CMC issues.
Manage short and long-term analytical development and testing needs for projects and impact into supply of drug substance and drug product and communicate levels to internal project teams.
Develop and update standard internal CMC plans, based on process and historical data, to provide guidance on cost and Analytical Development FTEs required for new Development projects
Manage transition of CMC project from research to development and from early stage to late stage production at a CRO.
Strengthen and maintain relationships with key Voyager project team employees and outside vendors and suppliers of CMC services.
Ensure project teams adhere to company and departmental policies, procedures, and standards for storage of data related to product production
Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings
Execute all aspects of people leadership, including performance evaluations, mentorship, and ensure effective development plans for all employees
PhD or Masters in Virology, analytical chemistry, biotech, biochemistry or a related field
Minimum 8+ (with a PhD) or 15+ years (with an MS) of analytical development experience in industry
In-practice knowledge of the ICH for assay qualification and validation
Demonstrated ability to efficiently develop an assay from conception to a qualified/pre-validated state
Experience with bioassay development for biologics/vaccines/gene therapy
Experience managing outsourced analytical development
Strong project management skills
Candidate should be detail-oriented, self-motivated, goal driven, and should be able to work effectively on teams to progress projects.
Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment
Experience leading teams of at least 6 people
Ability to write and communicate effectively with cross-functional teams
Experience in developing methods and performing the analysis of AAV or other similar viral vectors
Strong expertise in bioassay development for viral vectors
Industrial experience and an understanding of the biologics/vaccines drug development process is desired
Experience leading assay development in support of approved BLAs
To apply, email email@example.com
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