MS&T Fill & Finish Value Stream Lead

CSL; Broadmeadows; On-site; AUD 150,000 - 200,000; Full time

Job summary

CSL Behring in Broadmeadows, Australia, is seeking a Manufacturing Science & Technology (MS&T) Filling Value Stream Lead (Engineer or Scientist). You will lead frontline technical support for the fill & finish operations and help shape the MS&T strategy across the site and broader network.

The role requires strong engineering or life sciences background, 7+ years in pharma manufacturing, and proven ability to lead cross-functional teams while delivering compliant, data-driven improvements in

Qualifications

• Must hold MS/MBA/BS/BA in Engineering or Life Sciences.
• 7+ years in science/engineering within pharmaceutical manufacturing.
• Experience leading matrix or direct teams is desirable.
• Strong problem-solving and data-driven mindset.

Responsibilities

• Identify KPIs to measure process performance in fill/finish.
• Prioritize MS&T reactive support and manage workload.
• Develop value stream strategy with site lead and stakeholders.
• Develop processes to prioritise work and drive improvements.
• Coordinate with Process Technology, Validation, QA and other functions.
• Ensure compliance with safety and regulatory requirements.
• Translate performance data into stakeholder-friendly overviews.

Skills

MS&T leadership

Frontline technical support

Cross-functional teamwork

cGMP knowledge

Problem solving

Data analysis

Regulatory awareness

Education

MS/MBA/BS/BA in Engineering or Life Sciences

Job description

The Opportunity

The Process Engineering function at CSL Behring is recruiting for a Manufacturing Science & Technology (MS&T) Filling Value Stream Lead (Engineer or Scientist) to join our dynamic team at the Broadmeadows site. This exciting full-time permanent role will lead time-important frontline technical support within the filling production space and develop in partnerships the MS&T strategy within the Fill & Finish space in support of our life-saving parenteral manufacturing operations and strategic project execution.

You will apply fundamental scientific and engineering knowledge to the design, implementation and life cycle management of complex process and technology.

You will work with a broad range of local and global counterparts spanning three continents and functions as diverse as Manufacturing, Operational Analytics, Engineering, Quality, Technical Transfer, Validation, Research & Development and Regulatory Affairs.

The Role

Reporting to the Director, MS&T Site Lead, your responsibilities will include:

• Identifying key pro-active indicators to measure process performance across the fill and finish value stream and adjust, improve or update the process to optimise and realise quality and/ or yield opportunities

• Delivering day to day prioritisation of MS&T re-active support across the fill and finish value stream to manage workload

• Supporting the development of MS&T fill and finish value stream strategy in partnership with the MS&T site lead and stakeholders to plan and prioritise proactive improvements

• Developing processes for the fill and finish MS&T function to prioritise work, identify the highest value improvements and facilitate scoping and execution of implementation within internal PE functions (Process Technology, Qualification, Validation, Execution Systems etc.) and across key partner functions (Value Stream, Project Delivery, Quality Assurance etc.)

• Building the structure in conjunction with other MS&T value stream leads and MS&T Principals to capture and build process understanding

• Interacting with global counterparts and colleagues to identify synergies across multiple facilities in order to prioritise activities

• Owning and interpreting key value stream KPI’s to ensure the process is reliably and repeatably producing

• Structuring with MS&T Principals ways to test theories and prove root cause using data, internal and external expertise and lab based capabilities

• Assuring compliance with safety and regulatory requirements during all phases of MS&T activity

• Providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval

• Generating regular Product/Process performance overviews that are translated to a language relevant to stakeholders

Your skills and experience

• MS/MBA/BS/BA in Engineering or Life Sciences

• 7+ years experience in Science/ Engineering within a pharmaceutical manufacturing operation or in a pharmaceutical operation

• Experience leading matrix teams or leading teams directly desirable

• Ability to understand “the big picture” and approach problem solving in a proactive team manner

• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility

• Understanding of project management principles and project lifecycle phases

• Knowledge of Validation, CMC and facility regulatory submission requirements

• Demonstrated experience leading complex scientific investigations

• Experience with complex processes, technology and analytics

• Direct experience with regulated environments (i.e., cGMP, OSHA, EPA)

• Strong resourcefulness, drive, communication, collaboration, and conflict management skills

• Demonstrated ability to thrive in cross-functional, multicultural and international teams

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.