Scientific Associate II - Holly Springs North Carolina

Company: CSL Seqirus
Location: Holly Springs, North Carolina
Posted On: 05/17/2024

Job DescriptionDo 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 in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. 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 II will be reporting to the Sr. Manager, mRNA Vaccine Manufacturing. The Scientific Associate II will support cGMP readiness and tech transfer activities of early phase clinical trial manufacturing processes. The associate would support the below. - -You will work onsite at our CSL Seqirus in Holly Springs, NC location Monday-Friday during primary business hours. Our benefits include an Onsite Caf--, 1/2 mile Walking Trail, Basketball and Tennis Courts; 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:

• Author/own cGMP documentation (SOPs, Batch Records) and technical documentation (Gap Assessments, FMEA Assessments, Technical Protocols/Reports, etc.). You will handle creating, revising, and withdrawing documentation, including ownership of related compliance actions.
• Ownership and execution of Change Controls (CCs)
• Provide support for generation of SAP material codes and creation of BOM (bill of materials) builds
• Support manufacturing activity for development batches and tech transfer batches
• Support equipment qualification activitiesFollowing Tech Transfer the CTM associate will be responsible for support manufacturing activities to produce cGMP batches which includes:
  • cGMP manufacturing (Drug Substance and Drug Product)
  • Use SAP for GMP material inventory management (issuance/receiving of materials, cycle counting)
  • Ownership/execution of quality based workflows (Deviations/CAPAs). Investigation experience
  • Maintain the CTM area in cGMP compliance, which includes executing routine PMs on process equipment, 5S (area organization and material inventory), and equipment logbook managementMinimum Required Qualifications:
    • 3 years experience in pharmaceutical manufacturing, or another similarly regulated environment
    • Demonstrated technical writing skills and manufacturing document ownership
    • GMP experience preferred
    • Bachelors or postgraduate degree and /or extensive experience in relevant discipline.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.Our BenefitsCSL 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 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 .We want CSL Seqirus to reflect the world around usAs 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 'On the Front Line' video to learn more about CSL Seqirus More...

          

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