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GENERAL SUMMARY OF POSITION:

The Process Development Associate II will be responsible for upstream cell culture process development and downstream biologic purification activities such as the design and execution of laboratory experiments and process optimization, scale-up and technical transfer to cGMP manufacturing for the production of vectored biologic therapies.

MAJOR RESPONSIBILITIES:

• Performs mathematical modeling, design and data analysis supporting biologic process development.
• Performs analysis of data by statistical or DoE software, and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports.
• Assists with the scale-up & technical transfer of cell culture and purification processes to GMP Manufacturing.
• Assists with troubleshooting, root cause analysis and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues.
• Operation and maintenance of laboratory and pilot-scale cell culture and biologic purification systems.
• Perform analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required.
• Keep accurate records in notebooks, organize and report results.
• Prepare written and oral reports for presentation to the development group and senior staff.
• Maintain reagent inventories, order supplies, cleaning of laboratory areas, hoods, incubators and group equipment.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies. 
• Perform additional job related duties as required.

REQUIRED QUALIFICATIONS: 

• Requires a Bachelors degree in Chemical Engineering, Chemistry, Biochemistry or related field with a minimum of 2 years relevant work experience.
• Prior experience with biologic purification or cell culture and aseptic techniques preferred.
• Familiarity with Microsoft Office & JMP or similar statistical software
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training.
• Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
• Ability to troubleshoot within scope of training.
• Strong critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
• Excellent written and verbal communication skills. Ability to communicate effectively with others.
• Ability to work effectively both independently and as a member of a team.
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
• Occasionally projects require flexibility in work schedule to meet business needs.