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Scientific Associate I - Stability Coordinator

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
May 3, 2022

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Discipline
Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Job Description

Job Summary

The Associate Scientist I incumbent will provide sample support in TD lab to include the administration of in-process, stability samples, and TOX samples primarily in support of the sa-mRNA project.  Additional responsibilities include a basic understanding of LIMS system, effective interactions/communication with TD management, and support of investigations.  The Scientific Associate I should be able to work effectively within

Major Responsibilities

Supportive Work

  • Support sample management activities including but not limited to sample submission, sample receipt, external testing
  • Assist in stability LIMS builds and stability sample pulls, participate in sample forecasts to ensure lead time notice, and turning samples over to lab for testing
  • Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
  • Responsible for reporting issues to management and participating in issue resolution (such sample integrity issues, sample plan errors etc.)
  • Responsible for contributing to and/or handle laboratory investigations for events.
  • Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
  • Data collection and reporting with knowledge of GLP/GMP environments.
  • Work closely with the Separation, Biochemistry, and Molecular and Cellular Biology groups within TD-Analytical
  • Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes that the employee is trained on.
  • Able to work under tight deadlines.
  • Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
  • Partner with diverse team members from various functions, countries and members at various levels in the organization.
  • Functions effectively as core team member.
  • Preferrable to have experience with with electronic business systems (e.g, LIMS, SAP, EDMS)
  • Write and revise documents such as SOPs and technical reports as required

Operations/Quality Support

  • Serves as interface between TD and Operations, and represents TD department in cross-functional forums
  • Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing 
  • Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work
  • Generates a supportive business case, and supports cross-functional teams to deliver those opportunities

Minimum Requirements
  • Bachelor’s Degree in related scientific field and 0+ years experience
  • Hands on assay experience with electrophoresis, immunoassay and other
    protein analysis required
  • 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
  • Evidence of commercial awareness in technical strategies
  • Excellent customer focus with demonstrated management of customer expectations

Preferred Attributes
  • Experience with a LIMS system is highly desired
  • Experience with analysis of proteins and/or RNAs is highly desired
  • Experience in biopharmaceutical analytics is desirable

    About Us

    Our Benefits

    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.

    About 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!

    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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