Manufacturing Associate - 2nd Shift

Summary

This role exists to provide support for the manufacturing of gene modified autologous T-cell product at our manufacturing site in the Philadelphia Navy Yard. The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary.

Duties And Responsibilities

• Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.
• SME on unit operations.
• Documents production operations in corresponding batch records and logbooks per established procedures ensuring accuracy and timely completion.
• Identifies real-time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner.
• Works on project teams (continuous improvement initiatives)
• Inputs and uploads of manufacturing data in real time to existing database.
• Reviews Batch Records and logbooks / comment resolutions.

Qualifications

• Bachelor’s degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
• Demonstrated strong understanding of GMP/GDP (21 CFR Part 210/211 & 21CFR Part 11).
• Experience working in an aseptic cleanroom with full aseptic gowning.
• Excellent verbal and written communication skills are required.
• Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.

Competencies

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Computer Skills – Skilled with computers; Takes advantage of new technology; Learns new tools quickly; Uses technology to enhance job performance.
• Conflict Management – Good listener; Committed to finding solution to problems; Works well with people.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.