Job: Senior Manager, Virus Validation – CSL

Date posted: 4 March 2019
Closing date: 31 March 2019

The opportunity

We have an exciting opportunity available for a Senior Manager, Virus Validation with a strong background in process development and process sciences to join the Global Pathogen Safety (GPS) team located at CSL Behring’s (CSL) Broadmeadows (BMW) site. You will provide leadership and guidance to teams responsible for developing robust process steps and conducting virus validation studies using scaled down models of our global plasma, recombinant, and gene therapy manufacturing processes.  In addition, you will be responsible for coordinating the management of resources, the Marburg, Virus Validation GPS team, to ensure that studies are conducted in an efficient and timely basis to support the overall CSL business needs.

As Senior Manager, you will be responsible for leading a high performing team responsible for the generation of data to support CSL’s pharmaceutical products (both in development and licensed). This includes appropriate R&D, Regulatory, Quality, and Manufacturing support.  You will possess an in-depth knowledge of process development and Quality by Design with a demonstrable ability to link that knowledge with the requirements of virus validation.

You will be responsible for actively leading your teams, providing individual development opportunities for employees, identifying talent, and providing career growth opportunities consistent with CSLs Promising Futures programs.

You will also be required to participate in the development and subsequent execution of high-level strategies by GPS AU and liaise with external vendors to ensure global alignment both with regulatory guidelines/expectations and within GPS.

You will provide support in maintaining relationships with regional regulators and stakeholders on PS-related topics, as well as in enhancing CSL’s visibility as a leader in PS matters.

Due to the global nature of the position, you will be required to participate in global teleconference meetings outside local business hours.

Key responsibilities include:

  • Provide leadership within the GPS (AU) leadership team and within the broader GPS organisation as an Extended Leadership team member. Provide strategic input towards enhancing the scientific acumen of the global PS laboratories. Partner effectively with key members and stakeholders across the global CSL organization
  • Seek innovative approaches and encourage progressive approaches to streamline work packages while maintaining and enhancing quality standards in line with regulatory expectations such as the OECD Principles of Good Laboratory Practice (GLP).
  • Design process scale-down process qualification to enable the conduct of validation studies for new or existing products performed at CSL’s PS laboratories
  • Build and lead a high performing team responsible for the generation of laboratory-based studies according to the Principles of QbD and GLP.
  • Lead and execute tasks related to global PS projects that support identified business needs.
  • Assist the Director, GPS (AU) in the development of strategies to deal with blood-borne emerged, emerging or re-emerging infectious diseases as well as in the development and maintenance of effective relationships with external agencies that will contribute to CSL’s overall strategic plans.

Essential qualifications/experience:

  • PhD in biotechnology/biochemistry/related biological field OR B.Sc. Hons. (or equivalent) with extensive demonstrable experience in process development. An understanding of scale down modeling of manufacturing processes is essential. Knowledge of pathogens (virus or prions) would be an advantage.
  • Minimum 10 years of experience in biologicals R&D.  Demonstrated experience in people management and leadership of staff essential. Leadership of teams involved in virus validation studies in accordance with OECD Principles of GLP would be a distinct advantage.
  • Experience working across sites and as part of international teams is highly desirable.
  • External recognition as a scientific expert in the field of biological process pathogen safety or similar and a record of scientific publication and presentations at international scientific conferences is preferred.

How to Apply:

Applications must address the selection criteria above and include a current CV and covering letter. Please apply via the following link: Senior Manager, Virus Validation

Applications close Sunday 31 March, 2019

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process.

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