Scientist I or II - External Analytics

The Opportunity

As a Scientist II and core Technical Development team member, you will report to our Associate Director to manage external analytics for our TD Analytics team.

Development Work:

• As the main point of contact, you will provide technical support for the contract testing labs and CMOs to ensure the outsourced work is performed in line with quality agreements.
• You will project manage and assist site management with setting up new procedures relate to external analytics, lab compliance, and other various activities related to lab operations and proactively identify improvement opportunities.
• You will acquire data reports and review of laboratory data generated by contract test labs/CMOs and enter applicable information in the data base (i.e. LIMS, reports in EDMS)
• Using the data, you will participate in data trending with TD Stability management
• You will manage TD budget for contract labs and CMOs
• You will author study protocols, development and characterization reports
• You will ensure all experimental procedures and documentation compliance
• You will 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 TD   

Operations/Quality Support:

• You will partner with QA to ensure that all release and stability testing, analytical method transfers, data review and trending, deviations, and investigation resolutions are performed at a high quality and in a timely manner in line Work instructions and/or quality agreements
• You will use scientific knowledge to provide support for product and testing related investigations that require support for development work for us.
• You will perform and assist in statistical analysis of contract or CMO data.
• You lead deviation investigations with TD Quality oversight for us.

People Management:

• You will provide guidance and mentorship to less experienced colleagues and team members

• Minimum 3+ years of experience for BS in pharmaceutical/biotech industry is required.
• 6+ years plus BS in pharmaceutical/biotech industry along with experience overseeing contract laboratories and/or CMOs is highly preferred
• Use your knowledge of a variety of analytical techniques such as: HPLC, UV/Vis, Particle Size Analysis, Endotoxin & Sterility testing
• Experience in biopharmaceutical development in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product
• Project management utilizing knowledge of cGMP/ICH/FDA/EU regulations work and excellent communication and analytical skills.
• Up to 20% domestic, regional & global travel

Benefits Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.