Full Job Description
Are you passionate about science and have a drive to apply yourself to understanding how manufacturing processes can impact product safety?
As an Advanced Research Associate on the Viral Clearance team, you will apply chromatography, cell culture, bioassays, and molecular biology techniques to evaluate the impact of various purification conditions and processes on the inactivation and removal of model viruses from our products. Working in a BSL-2 laboratory environment, you will assess viral clearance using model viruses and contribute to ensuring product safety. You will also support the development of new methods and prepare summary reports that document the effectiveness of manufacturing processes to clear viral loads in support of regulatory submissions for our GMP products. In this role, you will work with animal-derived model viruses in an environmentally controlled facility and will have the opportunity to contribute to process improvements while performing additional duties as assigned.
Key Responsibilities:
• Develop and conduct moderately complex experiments and report test results in compliance with SOPs and GxP standards.
• Maintain accurate, complete, and audit-ready laboratory and product documentation, including drafting and revising SOPs.
• Support projects and new product development.
• Prepare technical reports and clearly communicate findings to team members and key stakeholders.
• Participate in new method development and validations, as well as cross-functional projects and team meetings.
• Perform troubleshooting investigations.
• Identify and implement continuous improvement opportunities to enhance testing quality and operational efficiency.
• Collaborate with Operations, Process Engineering, Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs (RA) to ensure consistent and robust process performance.
• Perform laboratory support functions, including instrument calibration and maintenance, reagent preparation and ordering, waste disposal, and laboratory cleaning.
• Adhere to company policies and safety requirements, including AWAIR, Chemical Hygiene, and Exposure Control guidelines.
Education and Experience:
• Bachelor's degree in Biological Sciences or a related field with a minimum of 3-5 years of relevant laboratory experience, or a Master's degree with up to 2 years of relevant laboratory experience.
• Industry experience, including familiarity with GMP environments, is preferred.
• Experience with viral clearance methodologies is preferred.
Knowledge, Skills and Abilities:
• Knowledge of cell culture, protein chemistry, molecular biology, and associated laboratory techniques, with demonstrated hands-on proficiency.
• Understanding of quality systems and experience working in regulated environments (e.g., GMP, ISO).
• Attention to detail, organizational skills, and demonstrated proficiency in data analysis and problem-solving.
• Critical-thinking skills, with the ability to apply technical knowledge to troubleshooting and project execution.
• Ability to work effectively in a fast-paced environment, manage multiple priorities, and communicate clearly both verbally and in writing.
• Ability to produce accurate, high-quality work and maintain thorough documentation.
• Experience developing, reviewing, and implementing standard operating procedures.
• Effective interpersonal communication skills, including the ability to collaborate and present technical information clearly.
• Self-motivated learner with the ability to quickly acquire and apply new techniques using available resources.
• Ability to work independently on routine assignments and work with a team.
• Proficient in Microsoft Excel and standard Windows-based applications.
• Ability to handle sensitive and proprietary information with discretion.
• Commitment to safety and adherence to company policies and procedures.
• Ability to work hours that adhere to standard business operations (8:00 A.M. to 5:00 P.M.)
• Ability to meet project timelines and adapt to changing priorities, including flexibility to work additional hours as needed.