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Sr. Scientist, Technical Operations II

Employer
CSL Behring
Location
Kankakee, Illinois
Start date
Nov 15, 2019

View more

Discipline
Manufacturing & Production, Science/R&D, Biotechnology
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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

• Provide scientific expertise and guidance in the application of relevant technology platform to research and product development activities.
• Ensures high quality application of technology platform in order to support designated project objectives
• Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity
• Work together with and provide expertise to other team members in order to achieve specified research project objectives within defined time parameters.

• Postgraduate degree (preferably MSc or PhD) and / or experience in relevant discipline
• Minimum of 3 years relevant industry experience and / or equivalent experience in a relevant academic environment.
• Experience in project work and excellent communication and analytical skills.
• Excellent communication skills (English language)

The Sr. Scientist, Plasma Product Development (PPD) Technical Operations II (TO II) is responsible for leading and executing PPD R&D process improvement activities in support of local manufacturing operations related to CSL Behring's commercially licensed products and intermediates. Support activities can also extend out to other CSL Behring global manufacturing sites producing plasma products or intermediates. The scope of the role includes driving process improvements (e.g., yield, robustness, and cost), collaborating with the data analytics team to troubleshoot process challenges and identify improvement opportunities, and providing technical leadership on projects.

The incumbent applies advanced knowledge of job area and follows methodical process optimization and scale-up/down approaches. Coaches and reviews work of Scientist I/Scientist II staff as applicable. Implements process changes with cGMP compliance. The incumbent is responsible for ensuring that studies are executed according to the site priorities using representative and qualified scale-down and pilot scale models per existing policies. The incumbent will display team work and global perspective while collaborating with other global PPD R&D groups in alignment with CSL Behring's PPD strategic objectives.

The Sr. Scientist, PPD TO II will be expected to keep abreast of new technologies and approaches and strategically employs these into the improvement and optimization of protein separation/purification processes in order to increase safety, compliance, and/or commercial profitability. Solves difficult and complex problems requiring understanding of a broader set of issues and strong cross-functional collaboration.

1. Focuses on medium to long term deliverables. Areas of responsibilities include:
  • Building project plans and defining problem scope/problem statement.
  • Ensuring agreed targets for quality, timelines, costs, and user requirements are met.
  • Executing project plans with clear goals and adherence to timelines/resource constraints.
  • Effective partnership with Manufacturing, PD, BTT, TOI, and Data Analytics functions to identify feasible process improvement opportunities.
  • Leading and executing protocol driven process improvement studies through effective utilization of DoE methodology.
  • Scale up from bench to pilot scale; scale down from commercial to bench/pilot scales.
  • Technical transfer to pilot scale and commercial scale.
  • Define process characterization plans and implement support strategy for validation activities.
  • Aligning functional outputs with developments in Regulatory and Quality guidance (e.g. ICH Q8/9/10/11 and FDA/EMEA process validation guidance).
  • Implementing best practices in bioprocess support (e.g. application of DoE, QbD, new technologies).
  • Full documentation of Process Improvement activities according to appropriate Quality standards and in support of IP.
  • Ensuring data integrity and scientific rigor in TO experiments
  • Support of regulatory filings and regulatory audits as appropriate.


2. Coaches Scientist I/Scientist II colleagues in process optimization strategies in alignment with Management. Manages projects and processes, working independently with limited supervision.

3. Required to maintain an appropriate level of documentation and communication through timely and thorough drafting and execution of protocols and reports in support of R&D process development or operations support.

4. Ensure data integrity and scientific rigor in TO experiments. Own complex experiment design and execution.

5. Required to maintain an awareness of and compliance with current Good Manufacturing Practices and Good Laboratory Practices.

6. May be required to complete additional duties/responsibilities assigned by Management. Job responsibilities may require off-shift support.

Education

Minimum requirement: BS/BA in science related fields such as Chemistry, Biochemistry, Bioprocess Engineering

Bachelors of Science with 8+ years relevant experience

Or post graduate degree with 3-6 years relevant industrial experience

Experience
  • Required: Technical knowledge of product life cycle management, process change management, project management, and plant operations. Expertise in statistical analysis and design of experiment
  • Preferred: plasma fractionation experience and hands on experience with protein separation/purification process optimization and scale-up/down are required.


Competencies
  • Leadership
  • Time Management
  • Prioritization
  • Results Driven
  • Team Player
  • Negotiating
  • Communicates Effectively
  • Decision Quality
  • Drives Results
  • Self-Development
  • Instills Trust
  • Manages Complexity
  • Collaboration
  • Problem Solving

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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