Job Description

The Opportunity:

You will be responsible for leading Bioassay assay development and testing for mRNA program in Waltham. You will be responsible for the design and execution of analytical method development activities utilizing Cell and Molecular Biology techniques. You will Lead scientific associates to develop key assays for release, characterization, in-process control of novel mRNA products. You will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits.

The Role:

Contribute to the development and qualification of Molecular Biology analytical assays to support process and product development, including characterization and quantitation analyses of both in-process samples and final products.

Evaluate novel Molecular Biology analytical technologies, propose new assays or improvements to current methods.

Work closely with the Molecular Analytics, Separation Science, Biophysics, and Mass Spec groups within Global Analytical Development, as well as provide technical expertise in support of process development groups.

Author study protocols, characterization reports, and/or 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

Function effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes.

Serve as interface between BPD and Operations and represents TD 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 complaint, deviation, OOE and OOS investigations that require support for development work.

Generate a supportive business case and supports cross-functional teams to deliver those opportunities.

Provide guidance and mentorship to less experienced colleagues and team members.

Demonstrated leadership abilities through project leadership and mentoring.

Complete individual training and maintains a state of compliance.

Adhere to all safety requirements.

Support communication/updates as required.

Your experience:

Master\xe2\x80\x99s Degree or PhD in related scientific field

2-4 years with PhD or 5-8 years with MS

Requires in-depth conceptual and practical expertise in the development of cell-based bioassays for biologics or vaccines.

Extensive experience in working with cell culture and Flow Cytometry required.

Experience in immunoassays and/or molecular assays (qPCR, RT-PCR, digital PCR, etc).

Previous experience in working with mRNA highly desirable.

Provides technical advice on issues within own discipline.

Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving.

Experience in biopharmaceutical analytical development is desirable.

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.

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

Our Benefits

CSL 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 you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL .

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL Seqirus.

Do work that matters at CSL Seqirus!

Watch our \xe2\x80\x98On the Front Line\xe2\x80\x99 video to learn more about CSL Seqirus

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