Senior Process Development Associate

Job Description

As a Senior Associate Process Development, you will be responsible for supporting technology transfer, process validation, and plant start-up. In this non-laboratory-based role, you will work cross-functionally within operations, leveraging your process development experience to drive efficient and scalable processes. You will collaborate with other site functions and network drug substance teams to achieve plant goals.

Responsibilities

• Support technology transfer and process validation.
• Participate in plant start-up activities.
• Work cross-functionally to drive efficient process development and scalable understanding of processes.
• Collaborate with site functions and network drug substance teams to achieve plant goals.
• Apply engineering principles and statistical analysis to resolve complex issues.
• Draft protocols and reports, utilizing strong written and verbal communication skills.

Essential Skills

• Process development experience.
• GMP (Good Manufacturing Practices) knowledge.
• Project management skills.
• Technology transfer experience.
• Downstream purification and protein purification experience.
• Experience with process scale-up.
• cGMP experience.

Additional Skills & Qualifications

• 2 years of proven experience in a technical role supporting biotechnology processes within regulated environments.
• Knowledge of biologics purification processes.
• Experience in process scale-up technology transfer and process validation.
• Familiarity with operational aspects of commercial biopharma manufacturing, such as process automation and single-use equipment.
• Knowledge of process monitoring tools like PI and SIMCA.
• Ability to work independently and produce quality results with minimal direction.
• High energy with the ability to multi-task and handle a fast-paced dynamic work environment.

Work Environment

This is a non-laboratory-based position. The role involves working in a dynamic and fast-paced environment, requiring high energy and the ability to multi-task. The work is collaborative, involving cross-functional teams and interactions with various site functions