Scientist II - Molecular Biology
- CSL Behring
- Start date
- Mar 23, 2023
- Science/R&D, Biology, Biotechnology, Molecular Biology
- Required Education
- Associate Degree
- Position Type
- Full time
- Best Places to Work
The individual is responsible for utilizing scientific expertise to lead commercial support and development projects through TD into Operations and providing ongoing technical support to Operations and Quality. Responsible for projects that will drive future growth through process improvements. Uses scientific knowledge to ensure studies are well thought out and have clear, measurable benefits. Leads and drives elements of these activities as required.
• Leads the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for TD
• Uses a data driven approach to progress development deliverables
• Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities
• Responsible for using scientific knowledge to support site / global projects Operations/Quality Support:
• Serves as primary interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC.
• Utilizes extensive knowledge and experience with biopharmaceutical processes (i.e. downstream purification, chromatography) to provide technical leadership for production of drug substance and drug product in a GMP environment, and analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing.
• Utilizes extensive knowledge and experience authoring and providing technical content for Biologics License Applications.
• Uses scientific and statistical knowledge to provide leadership for product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work. People Management:
• Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
• Demonstrated leadership abilities through project leadership and mentoring. Other:
• Completes individual training and maintains a state of compliance
• Adheres to all safety requirements
• Supports communication/updates as required
You will be responsible for the in vitro sa-mRNA synthesis, encapsulation and characterization methods. The scope of work will include the design of drug substance manufacturing process, close collaboration with purification and drug product development teams. Cross functional collaborations with the analytical, manufacturing and research teams are also expected. You will be expected to supervise and mentor junior scientists. You will provide scientific expertise for process and product development projects in technical development of vaccines.
Develop, optimize, and characterize IVT and LNP encapsulation methods to support process and product development.
Utilize multiple modes of product detection and quantitation including UV, NIR.
Work closely with DP groups within BPD-Process Development, as well Analytical, Manufacturing and R&D -Provide technical expertise in support of developed process within the process development groups
Author study protocols, development and characterization reports, as well as scientific manuscripts for external publication
Use a data driven approach to progress development deliverables
Present results at internal and external meetings
Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
Support the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for BPD
Proactively identify development and improvement opportunities
Functions effectively as core team member on multiple concurrent projects and leads small projects
Serve as interface between platform and pipeline teams, BPD and Operations, and represents BPD department in cross-functional forums to support manufacturing and QC.
Utilize knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing.
Use scientific and statistical knowledge to support product, process and testing related investigations and deviations including compliance, deviation, OOE and OOS investigations that require development support.
Generate a supportive business case, and support cross-functional teams to deliver those opportunities.
Provide guidance to junior team members, interns and act as a resource for colleagues with less experience
Skills & Experience Required:
Postgraduate degree (preferably MSc or PhD)
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
Requires in-depth conceptual and practical expertise in IVT and LNP methodologies
Experience with nucleic acid process development is highly desired
Experience with process modelling and CFD is desired
Provides technical advice on issues within own discipline
Values ethics, integrity and trust, perseverance and problem solving
Experience in biopharmaceutical development is desirable
Prior experience managing and/or mentoring junior associates is preferred
Values ethics, trust, perseverance and problem solving
Effective delivery of objectives in a complex matrix environment
Ability to deal with rapid change
Effective verbal & written communication skills in a cross functional environment
Attention to detail
Proactively owns and drives assigned tasks to completion
Ability to present solutions to complex and strategic issues
Evidence of commercial awareness in technical strategies
Excellent customer focus with demonstrated management of customer expectations
Effective presentation skills
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!
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
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