Seqirus Senior Scientist, Analytical Development (mRNA Platform) in Waltham, Massachusetts
The individual is responsible for leading assay development of Separation Science within Analytical Development. The incumbent will serve as an expert on key technologies of analytical chemistry of mRNA and LNP, develop advanced analytical methods for release, in process control, characterization, and stability of novel vaccine candidates and transfer to QC. This individual will also lead scientists or associates and drive the assay development, in-process testing, and tech transfer.
Leads the development and execution of strategies, plans, and develop methods to enable product and process development, and method transfers and improvements for Product Development of mRNA platform
Uses a data driven approach to drive 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 lead site/global projects
Serves as a primary interface between Analytical Development (AD) and Process Development and Research, and represents AD in cross functional forums to support mRNA vaccine development.
Lead the establishment of new analytical labs in new site (Waltham facility).
Utilizes extensive knowledge and experience to provide technical leadership for production and characterization of drug substance and drug product, support process development and manufacturing.
Utilizes extensive knowledge and experience authoring and providing technical content for IND and BLA.
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.
Provides guidance and mentorship to less experienced colleagues and team members
Demonstrated leadership abilities through project leadership and mentoring.
Completes individual training and maintains a state of compliance
Adheres to all safety requirements
Supports communication/updates as required
PhD (preferred) or MS in Analytical Chemistry, Chemistry, or related scientific field
6+ years with PhD, or 10+ years with MS
Applies deep specialized and/or broad expertise and is viewed as a subject matter expert (“SME”) in Separation Science of analytical development, mRNA and/or LNP experience preferred.
Experience in pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, etc. Extensive experience on HPLC, UPLC, SEC-MALS assay development required. Previous experience on GC and CE preferred
Automation experience is a plus
Demonstrated technical leadership.
Effective verbal & written communication skills in a cross functional environment
Attention to detail
Excellent project management skills
Good commercial awareness with evidenced application to technical strategies
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 benefits (https://www.seqirus.us/careers/how-we-care-for-you-at-seqirus) 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 Seqirus (https://www.seqirus.us/our-company) .
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 Diversity & Inclusion (https://www.seqirus.us/careers/diversity-and-inclusion) at CSL Seqirus.
Do work that matters at CSL Seqirus!
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.
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