Job Requirements

General:

• Degree in Chemical/Biochemical Engineering or equivalent
• Knowledge of safety principles, quality systems, and cGMP
• Experience working in a cGMP environment
• Knowledge of large scale biopharmaceutical manufacturing processes and equipment
• Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.

Level Specific:

• Mastery of basic manufacturing, engineering and/or scientific theories, principles and techniques used in biopharmaceutical manufacturing processes.
• Assumes responsibility for process, equipment or technology development.  Recommends and implements new technologies.  Independently designs, executes and interprets results from trouble-shooting activities and small-scale studies.   Monitors operations and is responsible for resolution of complex processing issues and manufacturing improvements.
• Works under general supervision. Work reviewed for soundness of approach
• Actively participates in group and project teamwork.  Drives project / process improvements.
• Champions assigned projects. Justifies goals to colleagues.  Acts as a mentor for those with similar or less expertise. Expected to lead cross-functional projects or teams.
• Contributions are integral to the achievement of PROP goals and production targets.  Contributes to advances in technological capabilities.
• Prime contact both within and across work groups and with outside collaborators, regulatory agencies, and vendors on significant technical matters.  Develops a network for technical issues within the industry
• Completes investigation, development and validation reports and drafts external publications where appropriate.  Creates, reviews and approves manufacturing documents.  Provides process and equipment knowledge and training to PROP and manufacturing partners.
• Contributes to regulatory filings. Effective communicator of ideas, project goals and results. Gives presentations across departments.
• Typically will have more than 5 years experience in industry or academia (including advanced studies) after receiving their Bachelors degree.  Hiring and promotion into this position will primarily be based on demonstrated ability to fulfill the job requirements outlined above.  The number of years of experience alone is not an adequate justification for hiring or promotion.