This role exists to support the manufacturing of gene modified autologous T-cell product at our manufacturing site in the Philadelphia Navy Yard. The Supervisor will be responsible for managing a team, shall be an SME on assigned Manufacturing Unit Operations, scheduling of daily operations, training, maintaining compliance as it relates to Manufacturing Operations and other manufacturing needs as necessary, commensurate with the level of training and experience of employee. The Supervisor will perform review/approval of documents such as deviations & validations. Work will be split between Grade B and Grade C aseptic manufacturing environment and the office area, 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.
- Manages Partial to Full Shift Manufacturing Staff -includes performance reviews, team meetings, one on one meetings, development planning, coaching/mentoring, Manage PTO requests/Time Off, On-the-Floor Supervision, and training.
- SME (Subject Matter Expert) Trainer on Manufacturing Unit Operations and Equipment. First line of response for troubleshooting and cross-functional problem solving. Escalates to Line Manager as necessary.
- Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner. Responsible for documenting all data in a compliant manner in MBR/eBRs and associated logbooks.
- 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
- Involved in Quality Output- May include but not limited to: Engagement in Compliance Forums (e.g. Aseptic Behaviors, GDP)
- Works with the Quality team to author and review out of specification (OOS) reports, deviation investigations and corrective and preventative actions.
- Daily scheduling of Manufacturing Operations including use of electronic systems (e.g. LIMS, SedApta, PAS-X, etc)
QUALIFICATIONS: - Bachelor degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
- Minimum 3-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 with 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.
- Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
- 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.
- Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
- Decision Making - Able to reach decisions; Takes thoughtful approach when considering options; Seeks input from others; Makes difficult decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions.
- 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.
- Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
- 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.
