MS&T Manager

Last updated 4 days ago
Job Type:Full Time

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Opportunity

We are seeking a MS&T Manager to join our dynamic team in our Manufacturing, Science and Technology (MS&T) function in Parkville (Australia). This is a 12 month fixed term role and your main focus will be to lead the redevelopment of the Quality by Design (QbD) program and product control strategy for Parkville products. You will be responsible for updating the Seqirus QbD program to align with CSL global policies and apply the updated program to the Seqirus PKV product portfolio.

The Role

Reporting to the MS&T Manager Process Sciences, your responsibilities will include:

  • Lead the redevelopment of the Seqirus QbD Program to align with CSL global policies and address audit findings

  • Update the Seqirus PKV policies and procedures, sharing information and updates across sites within Seqirus as required

  • Lead and ultimately deliver the QbD document suites and the Product Control Strategies for the products manufactured by Seqirus in Parkville

  • Influence related project activities to integrate the process knowledge into other functional areas to inform and support any related regulatory remediation and responses

  • Collaborate with the data analytics team to establish batch tracking and data trending as required to inform QbD assessments and product quality reviews

  • Responsible for transfer of knowledge and process expertise to embed QbD principles in manufacturing processes and ensure the knowledge is appropriately used by all functional areas

Skills and Experience

The successful candidate must have:

  • Tertiary qualification in a related scientific or engineering discipline

  • Minimum 8-10 years’ related industry experience such as pharmaceutical or FMCG

  • Strong knowledge and experience with GMPs and sterile manufacturing

  • Experience of biopharmaceutical production processes

  • Strong project management skills and ability to unleash outcomes and deliver against project requirements

  • In-depth knowledge of pharmaceutical/anti-venom//vaccine manufacturing processes and technology

  • Strong influencing skills

  • Experience of engaging with diverse stakeholders at varying levels within the organisation

How to apply

If this sounds like you and you are looking to further develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-123671.

Applications will close 5pm AEST on 29th October 2020.

CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.

Important notice to Employment businesses/ Agencies

Seqirus does not accept unsolicited referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Seqirus' Talent Acquisition to obtain prior written authorization before referring any candidates to Seqirus. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Seqirus. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Seqirus. Seqirus shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.