AskBio Inc

AskBio Inc

Director, Pre-Clinical Manufacturing

Durham, NC · Director

Sponsorship not specifiedDetected 30 days ago
Project ManagementProcess ImprovementRecruitingGMPCRISPRCell CultureResearchAnimal StudiesLeadershipCommunicationCollaborationPublic SpeakingWriting

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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • The Director, Pre-Clinical Manufacturing is a critical member of the Preclinical Manufacturing team in AskBio's RTP facility and will report to the Vice President of Preclinical Manufacturing (PCM) & Manufacturing Science and Technology (MSAT).
  • The strongest candidate would combine hands-on bioprocess credibility with the ability to construct a reliable operating system for supplying multiple preclinical programs ranging from small-scale early research products to large-scale toxicology batches.
  • This role will also act as a technical consultant and guide for our R&D, PD, and MSAT teams as they advance and refine our product pipeline for product quality, manufacturability, and commercial viability.

Responsibilities

  • Manage an ever-changing pipeline demand into feasible production schedules to balance urgency, manufacturing capacity, raw materials, equipment, analytical testing, staffing, and release timelines across multiple programs
  • Work with internal partners to create and maintain comprehensive project documentation, plans and progress reports. Generate and update project communication presentations to ensure stakeholder alignment
  • Support development of procedures and documentation systems to successfully perform specific unit operations in the production and characterization of plasmid DNA and rAAV vectors
  • Develop and maintain laboratory budgets are fiscally responsible and cross-department charges are managed appropriately
  • Develop, manage, and oversee operational excellence programs to ensure continuous improvement within and between departments
  • Develop and maintain a strong partnership with Quality Assurance to ensure work streams maintain or exceed Quality and regulatory expectations

Requirements

  • Bachelor's degree in Chemical Engineering, Biochemistry, Biology or a relevant scientific or engineering discipline with10+ of hands-on industrial pharmaceutical or biotechnology experience
  • Experience in the manufacturing of the biologics (mAb, recombinant protein, vaccine, or viral vector)
  • Significant experience with complex statistical analyses and associated software such as JMP or R
  • Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
  • Experience with or knowledge of GMP quality
  • Advanced degree in relevant scientific or engineering field
  • Experience producing rAAV viral vectors in an industry setting
  • All agencies must have a prior executed service agreement with AskBio prior to any search engagement.

Nice to have

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need.
  • Provide an environment for employees to reach their fullest potential.
  • Cultivate Collaboration.
  • Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility.
  • We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Seek and provide constructive feedback.

Company info

  • Lead innovative science and drive clinical outcomes to transform people's lives.
  • Our principles:
  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
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