Manager, Purification Development - Melbourne, Australia

Details

Published on Wednesday, 22 February 2012 08:07

MANAGER, PURIFICATION DEVELOPMENT MELBOURNE, AUSTRALIA

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CSL Limited

The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 90 years experience in the development and manufacture of vaccines and plasma protein biotherapies.

With major facilities in Australia, Germany, Switzerland and the US, CSL has over 10,000 employees working in 27 countries.

Purpose of the Job

The Manager, Purification Development is responsible for the development of purification processes for recombinant proteins and monoclonal antibodies in CSL’s R&D portfolio from pre-clinical development through to scale-up for commercial manufacture and BLA/MAA submission. The scope of the role includes purification process development from final cell line selection, initial process definition, scale- up for pre-clinical supply, technical transfer to clinical manufacturing for Phase I/II, Phase III/commercial process development, scale-up support, process characterisation and support of process validation for BLA/MAA filing. The incumbent is responsible for managing a department of about 12 scientists & engineers, associated budgets and capital projects. The role is strategic, important in developing wider BioProcess Development strategy in line with developments in regulatory guidance, technological advancement, best practice definition and alignment with mid to long term R&D goals.

Reporting Structure

The role reports to the Senior Director, BioProcess Development. Roles that report to the position are Purification Senior Scientist Supervisor, Senior Scientists and Scientists

Responsibilities

Maintain, develop and enhance purification expertise for recombinant protein process development in CSL Australia and, with key contacts in CSL Behring, for the global CSL organisation Lead strategic thinking for purification process development in the wider context of product development, including: - Aligning policy with developments in regulatory guidance e.g.

ICHQ8/9/10/11 and FDA/EMA guidance on process validation - Defining best practice in bioprocess development e.g. application of

DOE methods, use of numerical risk assessments, application of principles of Quality by Design (QbD), implementation of high throughput approaches and technologies

With the BioProcess Development (BPD) leadership team, develop and implement mid to long term strategic objectives for the department, including: - Develop, review, maintain a 5 year plan for BPD, and where

appropriate wider Product Development, to ensure the organisation is

able to meet future portfolio demands e.g. from a maturing pipeline - Measure and ensure CSL process development practices are

competitive with the industry benchmark

- Map skills, resources and capital requirements to current and future needs, ensuring readiness for portfolio developments

Plan and oversee purification process development activities associated with allocated, therapeutic projects. Responsibilities in these areas include: - Ensuring agreed targets for quality, yield and recovery, costs and

timelines are met - Planning work and resources - Cost estimates for projects for internal and external customers - Contribution to final cell line clone selection - Provision of material for formulation development and analytical

method development - Initial process definition for tox and PhI/II supply - Scale-up and supply of material for GLP safety and toxicology studies - Technical transfer to clinical manufacturing - Phase III/commercial purification process optimisation studies - Process characterisation and support for validation activities - Full documentation and reporting - Supporting regulatory filings including IMPD, IND, BLA, MAA and others

as appropriate Provide effective leadership and management of Purification Development departmental operations, facilities, resources and staff, including: Manage, motivate and develop purification talent at all levels Preparation and assessment of performance objectives Management of key departmental activities and a budget of about one million dollars per annum Ensuring data integrity and scientific rigour for purification experiments; maintain proficiency in DOE and statistical methods Ensuring staff are trained in all technology required to maintain scientific excellence in the field Ensuring all facilities, plant and equipment are maintained in a state of operations fitness for purpose and compliance, including: - high throughput micro well systems - bench scale chromatography - non-GMP pilot scale purification from 500L cell culture - associated in-process analytics Identification of advances in technology and equipment in relevant fields, implementation of such within CSL and definition of best practise Ensuring compliance of departmental practices with CSL policies, AQIS and HSE requirements

Key Relationships

Senior Director, BioProcess Development Manager, Formulation Development and other key formulation staff Manager, Cell Culture Development and other key cell culture staff Manager, Bioanalytical Sciences and other key bioanalytical staff Manager, PD Projects & Technical Transfer and other key technical transfer staff Senior Vice president, Product Development Quality Control and Quality Assurance staff and departmental heads

Key staff in Research Key staff in CSL Behrings Project Leaders Molecule Experts/Technical Leads Regulatory Affairs Engineering/Maintenance Manager, Facilities and Services

Job Environment

This role is located at CSL’s Parkville, Melbourne site Working hours 10 day fortnight Necessity for local, interstate and international travel

Essential Qualifications/ Experience

Post graduate qualifications in a relevant branch of biological science or engineering. At least 10 years experience in related process development activities

Essential Skills, Knowledge & Attributes

Expertise in protein purification and protein chemistry Able to formulate a strategic vision for purification development in the wider context of drug development Outward looking; able to represent BioProcess Development beyond the purification development area Influential in interactions with key business contacts (internal and external) Strong leadership skills; able to communicate goals, motivate teams, coach and develop talent Results driven; able to deliver to target and organise teams to do so Excellent oral communication skills Excellent written skills; able to coach others to produce documentation meeting required standards Knowledge of wider drug development and regulatory requirements Knowledge of early and late stage process development, process characterisation and validation, technology transfer and scale-up, GMP and quality management systems (QMS) Strong skills in data analysis, interpretation, statistical methods and problem solving Ability to plan and organise work effectively for self and teams; adept at maintaining efficiency and throughput Confident, capable of making decisions with an impact beyond own functional area

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