Senior Scientist, Analytical Sciences Outsourcing

Share this job

Senior Scientist – Analytical Sciences Outsourcing

 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 scientist to manage the Analytical Development and Testing conducted at External Contract Research Organizations (CROs). The qualified candidate will be responsible, in collaboration with Voyager’s Analytical Development and Quality, to oversee the 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 at external CROs. Additionally, the individual will partner closely with Manufacturing to ensure constantly update status of lot release and any pending investigation or other issues requiring speedy resolution.

This position is located in Cambridge, MA, reporting to the Director, External Manufacturing & Supply. The candidate is required to travel, as needed, to CROs in US or overseas. Travel requirements will vary but may be up to 50%, as needed.

 

Primary responsibilities

  •  Develop external analytical development and testing project plans for existing and envisioned projects, with input from other Technical Operations functions (process development, analytical development, manufacturing and Quality)
  • Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
  • 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
  • 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.
  • 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 external CMC plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material 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

Minimum Qualifications

  • PhD or Masters in analytical chemistry, biotech, biochemistry or a related field
  • Minimum 5+ (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
  • Ability to write and communicate effectively with cross-functional teams

Preferred Qualifications

  • Experience in developing methods and performing the analysis of AAV or other similar viral vectors
  • Industrial experience and an understanding of the biologics drug development process is desired.

Senior Scientist, Analytical Sciences Outsourcing

Share this job

Senior Scientist – Analytical Sciences Outsourcing

 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 scientist to manage the Analytical Development and Testing conducted at External Contract Research Organizations (CROs). The qualified candidate will be responsible, in collaboration with Voyager’s Analytical Development and Quality, to oversee the 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 at external CROs. Additionally, the individual will partner closely with Manufacturing to ensure constantly update status of lot release and any pending investigation or other issues requiring speedy resolution.

This position is located in Cambridge, MA, reporting to the Director, External Manufacturing & Supply. The candidate is required to travel, as needed, to CROs in US or overseas. Travel requirements will vary but may be up to 50%, as needed.

 

Primary responsibilities

  •  Develop external analytical development and testing project plans for existing and envisioned projects, with input from other Technical Operations functions (process development, analytical development, manufacturing and Quality)
  • Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
  • 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
  • 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.
  • 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 external CMC plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material 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

Minimum Qualifications

  • PhD or Masters in analytical chemistry, biotech, biochemistry or a related field
  • Minimum 5+ (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
  • Ability to write and communicate effectively with cross-functional teams

Preferred Qualifications

  • Experience in developing methods and performing the analysis of AAV or other similar viral vectors
  • Industrial experience and an understanding of the biologics drug development process is desired.