Manufacturing Specialist II

Job Description

Job Description

SUMMARY:

This role exists to provide support 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, commensurate with the level of training and experience of employee. Work is primarily in Grade B and Grade C aseptic manufacturing environment, but may also include support of process development runs in the Manufacturing Science and Technology laboratory.

DUTIES AND RESPONSIBILITIES:

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• 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.
• Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned. Handles human blood and human blood-based product intermediates; Helps with warehouse management, critical reagents and material inventory reports.
• Work on project teams (continuous improvement initiatives)
• Inputting and uploading of manufacturing data in real time to existing database.
• Review of Batch Records and logbooks / comment resolution.
• Responsible for authoring, editing, reviewing and/or approving manufacturing documents. These documents include but are not limited to:
  • Training records
  • Copies of patient batch records and the Certificates of Analysis of the Drug Product
  • SOPs and Batch Record versions
  • Equipment and other logbooks
  • Validation documentation
  • MEMOs, CAPAs/ Deviations
  • Executed logbooks and Batch Records
• Train new or junior employees on equipment and unit operations.

QUALIFICATIONS:

• Bachelor’s degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
• Minimum 2 year working with Advanced Cell Therapies withing a cGMP environment
• Ability to work flexible hours with some night and weekend availability is required. This is a start-up situation so schedules and shifts will change over time.
• Demonstrated strong understanding of GMP/GDP (21 CFR Part 210/211 & 21CFR Part 11)
• Ability to stand for multiple hours and lift 20 pounds.
• 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.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.