The Associate Scientist I will support the development, tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.
Perform Upstream and/or Downstream aspects of lab scale process development and GMP production including:
Upstream techniques Cell culture development (ex. CHO, 293, insect cell)
Growth media selection and optimization
Derivation and characterization of stable cell lines
Downstream techniques Chromatography development: Resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing.
Filtration Development: Development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration, sterile filtration.
GMP Production: Process scale up, tech transfer, and execution of the process under GMP conditions.
Execute and document development and GMP activities in compliance with regulatory requirements.
Support CGMP production, including equipment and material management, to ensure facilities and materials meet DHVI needs, perform investigations.
Provide support for cGMP campaigns, including documentation, deviation and root cause analysis.
Collaborate closely with other development teams to provide support for development activities and will work diligently with cell line development and analytical development functions to understand how the production process is impacts product quality.
Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data and present results.
Write and reviews technical development reports; assist with writing protocols for tech transfer and SOPs for GMP production, and present data to project teams and larger settings.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field
Knowledge and hands on classwork with cell culture or protein purification techniques and basic analytical techniques; hands on implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is preferred
Experience in either upstream (cell culture, bioreactor operation including scale up) or downstream purification (chromatography, tangential flow filtration, normal flow filtration) and basic analytical techniques to support upstream or downstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis, colorimetric methods).
Must have the ability to independently to develop specific processes or methods with guidance from senior scientists/managers.
Demonstrated ability in solving moderately complex analytical problems with guidance from senior development scientists.
Strong oral and written communication skills
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.