CSL Plasma Inc

You will contribute to assay development and sample testing of in-process samples, drug substance, and drug product using analytical tools.. Be an interface between Analytical Development and QC GMP to support assay transfer, qualification, and validation.. Experience in method development of bioassay, immunoassay, or molecular biology assay.. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.. 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.

analytical development

Scientific Associate (Analytical Development) page is loaded Scientific Associate (Analytical Development) Apply locations Seqirus USA - MA - Waltham time type Full time posted on Posted 2 Days Ago job requisition id R-229155 Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
The Scientific Associate will report to the Senior Scientist and will work onsite in the Waltham, MA office. You will work on the analytical development to support the process and product development of mRNA/LNP vaccine products. You will contribute to assay development and sample testing of in-process samples, drug substance, and drug product using analytical tools. You will support process development, product release, stability, and characterization of toxicology and clinical trial materials.
Our benefits include an Onsite gym, cafeteria, barista coffee bar, free onsite parking and bike storage, access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.
Responsibilities
You will develop analytical methods and perform qualitative and quantitative analysis.
Develop phase-appropriate bioassays, molecular biology assays, and biochemical assays to support process and product development across mRNA vaccine programs.
Complete analytical methods and sample testing following existing SOPs to support process development, product release, stability and characterization across mRNA vaccine programs.
Be an interface between Analytical Development and QC GMP to support assay transfer, qualification, and validation.
Support product process and testing-related deviations and investigations including complaint, deviation, OOE and OOS investigations.
Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
Support reviewing documentation in notebooks and data in ELN and LIMS for specific lab-based processes
Author method protocols, qualification/robustness/validation protocols and reports to support IND/BLA filing
Author study protocols, characterization reports, and scientific manuscripts for internal and external publication and patent application
Partner with diverse team members from functions, locations and at all levels in the organization
Qualification
Bachelor's Degree in related scientific fields with 1+ years of industry experience or Master Degree in related scientific fields
Conceptual knowledge and hands-on experience in cell culture, cell-based assays, qPCR/ddPCR, and ELISA. Proficient in operating and maintaining relevant instrument and software.
Knowledge of regulatory requirements and work experience in GLP/GMP environment (e.g. notebook documentation, data collection and review, result reporting).
Experience in method development of bioassay, immunoassay, or molecular biology assay.
Hands-on experience in separation science (CE, HPLC) and particle analysis (DLS).
#LI-Onsite
Our Benefits CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.
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 . 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 at CSL Seqirus.
Do work that matters at CSL Seqirus! Watch our ‘On the Front Line’ video to learn more about CSL Seqirus Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here . #J-18808-Ljbffr

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