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Director, Development And Manufacturing, Plasmid Dna

BioCina - Adelaide, SA

Manufacturing & Industrial
Source: uWorkin


BioCina is seeking a Director of Development and Manufacturing, Plasmid DNA. This key position will lead and develop our Plasmid DNA group. The focus of this newly created role will be leading BioCina’s capabilities to build a world class scalable production platform to support our preclinical, clinical development and commercial CDMO service offerings.

In addition, s/he, like all of our colleagues at BioCina, will live our company values of Passion, Accountably, Responsibility, Tenacity, Innovation and Excellence through their contribution to our CDMO services, a pursuit of personal continuous development and joy in the workplace.

S/he will interact with our Research and Development, Quality Control, and Quality Assurance teams to assure robust, efficient, and compliant processes are developed, implemented and maintained.


· Conceptualize and design plasmid DNA production and purification platform processes.

· Develop and lead a high-performing scientific and technical cross-functional team for upstream and downstream plasmid DNA (research and GMP-grade) production activities.

· Supervise manufacturing personnel in production of plasmid DNA conforming to cGMP guidelines.

  • Direct and manage multiple concurrent client projects while ensuring their success in meeting respective objectives and timelines.
  • Interface directly with clients to establish client specific product and processes requirements and drive growth for our business.
  • Collaborate with a cross functional team (business development, project management, supply chain, quality, and manufacturing sciences and technology) to evaluate manufacturing proposals, technologies, and processes.
  • Oversee procurement, installation, commission, and troubleshooting equipment as needed.
  • Participate in the development of a high performing culture focused on critical KPI’s.
  • Strong commitment to continuous improvement
  • Hire and retain and mentor key talent to meet strategic and tactical goals and KPI’s.


· Ph.D or advanced degree in biochemistry or related scientific field

· 10+ years’ experience in biochemical research or related area

· Experience leading teams, including direct supervision of R&D Scientists

· Track record of successful development of plasmid DNA manufacturing proceses

· Experience in CDMO operations

· Experience with cGMP manufacturing and demonstrated, applied knowledge of CMC and regulatory requirements.

  • Experience in manufacturing operations, including budgeting, CapEx procurement and I/O/Q, safety, and status reporting to Senior Management is preferred
  • Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
  • Ability to draft SOPs and support root cause investigations.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

This position and the experience required will qualify for the Global Talent program (Distinguished Talent visa) available to non-residents to be able to work and reside in Australia.