Sr. Associate/Principal Associate-Process Development Upstream

This is an incredible opportunity to join a pharmaceutical company with a bright future. The Associate will be responsible for production of viral and viral like particle vaccines, including adherent and suspension cell culture in bioreactor, infection/transfection, purification and ultrafiltration/diafiltration processes. The successful candidate will be able to work in a fast-paced team oriented environment and be able to learn new skills quickly. This position will report directly to the Manager, Process Development and Production.

Responsibilities:

• Perform adherent and suspension mammalian cell culture using disposable technologies
• Perform bioreactor operation and process development for mammalian suspension cells
• Perform viral or virus like particle purification by chromatography and ultrafiltration
• Perform lyophilization, encapsulation and capsule coating
• Author process development summary and tech reports
• Author manufacturing SOPs and batch records
• Design and execute studies to optimize viral and virus like particle vaccine production yields and stability
• Optimize mammalian cell culture and viral amplification in 10L to 200L bioreactor
• Lead and present projects within group as well as within the company

Requirements:

• Bachelors of Science/engineering in Biology, Chemistry, Chemical Engineering, or related discipline
• Minimum of 5-6 years' relevant industry experience, or MS degree plus the knowledge and skills acquired through 3 years' relevant industry experience
• Team player and collaborator, ability to listen and communicate in a clear and timely manner
• Cell culture experience and strong aseptic technique
• cGMP experience
• Strong organizational and technical problem solving skills
• Demonstrated ability to think and act independently; accept supervision, work quickly and accurately in a fast-paced environment, critically analyze data and proactively solve problems

Preferred Qualifications:

• Experience working with bioreactors, both rocker and/or stir tank
• Diafiltration/Ultrafiltration experience
• Design of Experiment experience, JMP software
• Understanding of the drug product manufacturing process and scale-up considerations

Travel: 10%