Senior Scientist, Cell and Molecular Analytics

The opportunity:

The individual is responsible for leading molecular assay development and testing for mRNA program in Waltham. The prospective scientist will be responsible for the design and execution of analytical method development activities utilizing Cell and Molecular Biology techniques. The incumbent will Lead scientists and/or scientific associates to develop key assays for release, characterization, in-process control of novel mRNA products.  The individual will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits.  Leads and drives project deliverables within timeline. 

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 Bioassay, 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.

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

• Serves as interface between BPD and Operations and represents TD department in cross-functional forums to support manufacturing and QC.

• 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.

• Provides guidance and mentorship to less experienced colleagues and team members.

• Demonstrated leadership abilities through project leadership and mentoring.    

Your skills & experience:

• 5+ years with PhD or 10+ with MS

• Requires in-depth conceptual and practical expertise in the development of Molecular Biology assays for biologics or vaccine molecules.  

• Extensive experience in working with DNA and RNA required.

• Hands on experience in qPCR, ddPCR, next-generation sequencing (NGS) required.

• 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.

• 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.

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.