Associate Director/Director, Analytical Development

Voyager Therapeutics Cambridge , MA 02138

Posted 3 weeks ago

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.

Responsibilities:

  • 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

Requirements:

  • 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

Preferred Skills:

  • 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 careers@voyagertherapeutics.com

Share this job


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior/Lead Analytical Development Associate

Recruitomics Consulting

Posted Yesterday

VIEW JOBS 12/14/2018 12:00:00 AM 2019-03-14T00:00 <div><b>COMPANY OVERVIEW:</b></div> <div>At Synlogic: We are Putting <b>LIFE </b>Into Medicines.<br />  </div> <div>We are pioneers in the development of Synthetic Biotic<sup>TM</sup> medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer.  </div> <div>Every day our teams work tirelessly to drive to deliver on 4 aspirations:  </div> <ul> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;"><b>People:</b>  <b>LIVING</b> each day with passion for building up and building out our Synlogic team</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;"><b>Platform:</b>  Expanding and enhancing the technology to generate and protect novel <b>LIVING</b> medicines with new and versatile mechanisms of action</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;"><b>Products:</b>  Rapidly developing and commercializing Synthetic Biotics that transform the <b>LIVES</b> of patients and their families</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;"><b>Promise:</b>  Building our company to launch multiple novel <b>LIVING </b>medicines – mastering a new frontier in medicine</li> </ul> <div>We combine Human Logic and Science Logic to drive meaningful work, careers, and <b>LIFE</b> at Synlogic.  We foster a people-focused environment grounded in:  Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire:  Innovation, Integrity, High Performance, and <b>LIFE</b> Changing Results.<br />  </div> <div>We continue to build and enhance our organization. If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you.  </div> <div><br /> <b>POSITION SUMMARY:</b></div> <div>The Analytical Development Scientist will lead phase-appropriate bioassay analytical development for potency and characterization of live biotherapeutic product candidates within the CMC function. The scientist will be part of a dynamic and motivated development team to bring Synlogic’s novel Synthetic Biotic™ medicines to clinical trials and eventual commercialization.  This position requires in depth bioassay experience in development of robust analytics.  This person will be responsible for providing critical expertise in a cross-functional CMC team.</div> <div><br /> <b>KEY ACCOUNTABILITIES/DUTIES:</b></div> <ul> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Develop clinical phase biological potency assays and establish product specifications, with support from the group lead.</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Develop assays to assess structure-function relationships and analytical characterization of the Synthetic Biotics™ to define critical quality attributes of the drug substance and drug product, with support from the group lead.</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Support bioassays used inthe GMP manufacturing, with support from the group.</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Prepare technical reports for all development activities and author SOPs in support of assay development.</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Support preparation of regulatory submissions, participate in their review and approval, and contribute in the development of strategies to comply with US and international regulatory standards.</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example.</li> </ul>   <div><b>QUALIFICATIONS & EXPERIENCES:</b></div> <div><b>Required Qualifications & Experiences:  </b>The following qualifications and experiences are required for the position:  </div> <ul> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">BS (MS preferred) in microbiology, biochemistry or related discipline with at least 3 and ideally 5+ years of experience in bioassay development for clinical and/or commercial-stage biological products</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Experience with potency assays for biotherapeutic products or probiotics</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Experience developing quantitative assays for enzyme kinetics, such as metabolite consumption or conversion of these assay formats for use as potency assays</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Experience qualifying/validating assays per ICH Q2(R1)</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Excellent oral and writing skills</li> </ul> <div><b>Preferred Qualifications & Experiences:  </b>The following qualifications and experiences are preferred: </div> <ul> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Quantitative and qualitative qPCR/PCR techniques</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Cell counting for in vitro and cell-based assays including cellometer or flow cytometry</li> <li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Endotoxin assay development for product release and chracterizaion</li> </ul>   <div style="padding: 0; margin: 0;"><b>BEHAVIORS:</b><br /> We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results.  Our 6 values of <b>Compassion, Fun, Trust & Respect, Innovation, Integrity and Results</b> are central to our organization.<br /> <br /> Our <b>compassion</b> for patients is the engine that drives our <b>innovation</b> and motivates our sense of urgency; always remembering that patients are waiting.  Our <b>compassion</b> for each other creates a safe environment for continuous risk taking and personal development.   We connect with our colleagues by having <b>fun</b> together.  We take our work seriously and value <b>integrity</b> in producing the highest quality work.  We <b>trust</b> each other, respecting all ideas and driving accountability to generate the best <b>results</b> for our patients and team.  We encourage openness, direct feedback and transparency in decision-making to enable <b>trust</b> and maintain the nimbleness of the group.</div> Recruitomics Consulting Cambridge Ma

Associate Director/Director, Analytical Development

Voyager Therapeutics