Head Sterile Product Technology

Salary depends on experience
Posted on 04/19/18
11 - 15 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 04/19/18

Head Sterile ProductTechnology

Position Summary

The successful candidate must have proven ability to meet development goals on aggressive timelines while having a record of effective collaboration with quality assurance and regulatory stakeholders.  Experience in integrating non-clinical formulation work, toxicology and clinical feedback into robust dosage forms and processes for regulatory submission is essential.  Deep knowledge of cGMP and other relevant regulations is required.  Experience with manufacturing facility design and operation is highly desired.  This position has significant visibility and potential for growth in a dynamic organization seeking to enable the breakthrough opportunity of mRNA therapeutics.

Responsibilities

  • Manage all activities for process development and manufacture of drug product processes
  • Build and lead a high performing team consisting of scientists and engineer
  • Manage internal and external (CMO) non-GMP and GMP formulation and filling activities.Identify, manage and contribute to external contracts as required.
  • Be the single point of contact for all drug product process for all partners and ventures in the Moderna ecosystem
  • Maintain accountability for project success and results delivery
  • Establish strong bridges with internal groups of formulation development, analytical development, and GMP operations. Interact with other R&D groups (clinical/PK/PD/Tox) to advance the science of RNA pharmaceutics
  • Contribute to technical and strategic discussions to advance platforms and product candidates
  • Communicate development progress and issue resolution

Minimum Qualifications

  • Ph.D. with at least 10 years of industry experience in biologics formulation process development including liquid and lyo dosage forms
  • Strong foundation in biochemical engineering or related discipline. A track record of achievement in product development, supporting clinical/commercial programs in biotech/pharma.  Filing of INDs and BLAs.
  • Proven ability to define, manage and maintain scientific business relationships and contract research / manufacturing agreements
  • Exceptional written and oral communication

Preferred Qualifications

  • Experience formulating nucleic acids for in vivo delivery, understanding of polyelectrolyte systems and polymer science related to nanoparticle formulations
  • Expertise in process engineering of nanoparticles containing nucleic acids
  • Awareness and understanding of adjacent areas in drug delivery and devices
  • Experience defining and executing development based on QbD principles
  • A record of building and motivating teams that collaborate effectively
  • Ability to inspire, mentor and develop staff across organizations

Competencies

  • Commitment to Excellence in Innovation and Execution
  • Results Orientation, Ability to Manage Performance
  • Flexibility / Adaptability to Frequent Change
  • Effective Communication
  • Personal and Shared Accountability
  • Talent Development

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