Director of Analytical Method Development / Quality Control - Abzena

Director of Analytical Method Development / Quality Control

Location: Bristol, PA
Area: Quality

The Director of Analytical Method Development (AMD)/Quality Control (QC) is responsible for the management of QC and Analytical Method Development of small molecules and/or bioconjugates including ADCs products manufactured within the Abzena Bristol facility.

The AMD/QC leader will be responsible for planning Analytical Method Development and Quality Control operations and managing a team of scientists and analysts to conduct analytical testing in a reproducible manner to confirm the product meets established criteria for safety, efficacy and purity. The position requires an exceptional technical leader with a thorough understanding of ADC or bioconjugate and/or small molecule methodologies, a solutions-oriented approach to problem solving, and outstanding team management skills.

 

Specific Responsibilities

  • Responsible for analytical control strategy aligned with Abzena’s sourcing strategy for products.
  • Responsible for the analytical development plan for products.
  • Lead analytical laboratory staff in the selection, design and implementation of novel analytical methods.
  • Primary contact representing AMD to other departments, CMC team, Regulatory, Manufacturing, QC, and Quality Assurance.
  • Contributes to and accountable for all analytical chapters in IND/IMPD/BLA/MAA.
  • Ensure a continued information flow among other departments and external collaborators/partners.
  • Represents AMD at authority meetings and teleconferences for analytical questions.
  • Contribute to development of an operating model and continuous improvement of platforms based on analytical development plans for the complete product life cycle.
  • Owns publishing and conference participation strategy of products for analytical development in alignment with the company strategy.

 

General Responsibilities

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
  • Travels as needed.

 

Qualifications/Skills Required:

  • Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or related disciplines, with at least 5 years’ experience or MS with 10 years and BS >15 years’ experience.
  • Analytical development scientist for biologics and/or small molecules development experience required.
  • Analytical Development and Quality Control experience with biologics and/or small molecule development experience.
  • Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process development.
  • Excellent communication, interpersonal, organizational, writing and managerial skills.
  • Regulatory agency interaction experience preferred.
  • Analytical sciences, cGMP compliance training, method development, qualification and validation experiences.
  • Requires strong organizational skills and attention to detail for composing and proofing relevant documents, materials, scheduling, establishing priorities and meeting deadlines.
  • Occasional travel may be required, for conference attendance and meetings with peers at off sites. Estimated travel should not exceed 10% of time.
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