Job Code:
Location: Australia

Position title:
Senior Scientist in Cell Culture; through to

Associate Director, Bioprocess Development

Reporting to:
Department Manager Fermentation development; through to Director, Bioprocess Development (depending on seniority of candidate)

Reason for vacancy:
New Position

Staff reporting:
· Fermentation Scientists; Senior Scientists, though to Departmental Managers (depending on seniority of candidate)


Other key relationships:
Internal

· Departmental Managers

· Manager Fermentation

· Director, Bioprocess Development

· SVP, Global Process Development

· QC Staff

· Purification Staff

· Research Scientists


External

· None

Broad scope of position:

To execute and document process development activities associated with mammalian cell culture, from small-scale pilot development to GMP manufacture. Work will include the development, use and optimisation of serum-free methods of manufacture for production purposes using statistically valid DoE methodology; including performing translational developmental work to take projects through late-stage development into commercial supply. The incumbent will work independently to achieve these goals. Depending on the level of seniority, this may involve direct hands-on laboratory work (for more junior appointees), but candidates must in all cases have the ability and accept the responsibility for supervising more junior staff. Leadership in advancement of technical knowledge and techniques for the product development group is essential.

Key duties and responsibilities:
For mammalian cell culture processes, to:

· Establish GLP and GMP working seeds or master seeds

· Plan, carry out and document small-scale experiments to define, optimise and validate processes

· Using statistically valid DoE methodology develop and optimize serum-free mammalian protein production conditions

· Develop and optimize fed-batch techniques

· Develop and carry out mid-stream processes as appropriate

· Scale up processes as required

· Conduct laboratory analytical procedures as required

· Conduct GMP production for preclinical and clinical studies

· Maintain plant and equipment and facilities in suitable condition for work program

· Evaluate early stage development expression constructs for suitability for large-scale manufacture.


· Plan, coordinate and implement all tasks associated with fermentation activities

Tasks include:

-Development of detailed plans and timelines

-Development of experimental protocols

-Decisions relating to technology to be employed

-Design, modification or acquisition of relevant plant and equipment

-Oversight of staff allocated to task

-Costing of experimental programs


· Embracing new technology to ensure scientific excellence is maintained

· Training staff in all aspects of cell culture development. Leadership role in a small group to be taken in technical aspects of recombinant antibody production, high cell density cell culture, media optimisation and cell physiology

· Supervision of junior staff



· Collegial assistance to peer staff


Key objectives of the position:

First 12 Months

· Via technical analysis assess current status of Parkville Product Development’s competence in this area

· Integrate candidate’s own learning and expertise in these areas to improve the technology

· Make recommendations and assessments of what currently doing, compare to previous approaches and implement changes

Long Term

· Play a leadership role in the fast moving R&D of cell culture systems

· Develop leadership role within the business

Performance measures:
Performance objectives will be set with the manager

Key challenges facing this role:
· This is a new area of focus and so the challenges involved are related to expertise-development for the company

· Demonstrable credibility as expert across the business