Director, Process Development Lead

1 week ago

Cambridge, Massachusetts, United States Arbor Biotechnologies Full time
About The Role:

As the Director, Process Development, you will report to the VP of CMC and provide strategic leadership to develop, establish, and drive the execution of the organization.

You will develop scalable manufacturing processes to support Arbor's gene editing pipeline.

You will define and execute process development and tech transfer activities to enable efficiency and differentiation in GMP manufacturing throughout the product lifecycle.

You will establish and implement best practices for generation and integration of product and process knowledge across the groups accountable for analytical testing, formulation, process development, process characterization and introduction of products into fill/finish operations.

What You Can Expect:
  • Owns the technical knowledge flow and cross functional integration required to secure completion of activities assigned across Product Development (Formulation), Process Development and its overall Transfer into Manufacturing.
  • Leads, guide and delivers outcomes in close partnership with the managers and lead scientists in charge of knowledge and clinical materials generation.
  • Oversees integration of control strategy elements including in-process and release testing for materials and products.
  • Directs staff and activities associated with Formulation and Product Development activities executed at Lab scale prior to their transfer into production.
  • Directs staff and activities associated with process development and associated characterization studies geared toward process transfer into production.
  • Drives innovative improvements in R&D to reduce cost, lead times and improve throughput.
  • Represents Process Development and Tech Ops in cross functional meetings. Sponsors integration of quality and innovative solutions culture. Leads continual improvement efforts.
What You Bring:
  • Bachelor's degree in scientific discipline
  • Minimum of 10 years' experience in biotech, pharma and/or life sciences
  • Viral vector experience with preference toward AAV
  • Experience with synthetic and IVT RNA products is highly desired
  • Familiarity with LNP formulations are a plus
  • Experience with Six Sigma, Lean manufacturing, Value Stream mapping experience a plus
  • Experience working in a startup that grew rapidly a plus
  • Positive attitude and good judgment, a person people seek out for advice
  • Excellent communication skills - oral, written, listening, inclusive of others' ideas
  • Trustworthiness, personal integrity; able to maintain a high degree of confidentiality
  • Effective time management and organizational skills
  • Personal accountability, learning agility, collaboration, personal touch and stewardship
Our Values:

Our values govern the work we do at Arbor, and we're hoping that they resonate as strongly with you as they do with us

Purposeful Action: Start with The Why

Bold Resilience: Adopt a Growth Mindset

Humble Authenticity: Start in the Heart

We promote diversity and inclusion not just in our recruitment processes, but in everything we do.

We're an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.

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