Actual Job Title: Manufacturing Team Leader
Position Summary
Supervise personnel and operational needs within the area of responsibility to ensure production of efficacious, safe, and high quality products in a Lean manner, while maintaining a safe and accident free environment. Promote and achieve an environment of high colleague engagement, decision-making, and scheduling of colleagues. Provide leadership and clear/concise communication inside and outside of their area of responsibility.
Position Responsibilities
In addition to the summary above, the team leader will ensure all group functions meet Corporate, APHIS, and cGMP quality aseptic standards and are in compliance with departmental SOPs. Provide leadership and accountability to meet production schedules and financial commitments. Ensure proper training for colleagues and facilities are operated in a safe, environmentally acceptable manner. Ensure objectives and goals are clearly understood by all department personnel. Investigate process excursions/deviations and production issues utilizing Right First Time (RFT) tools to ensure corrective actions are identified and implemented to eliminate the root cause of the problem. Initiate and implement ideas to improve production process reliability from the standpoint of quality, safety, and product cost. Assist in the planning of production and personnel. Assist with technical projects within areas of responsibility.
The position will also be responsible for certain planning transactions in support of filling, packaging, and miscellaneous site functions.
Education and Experience
Minimum Requirement:
BS in biological sciences or related discipline. Two years supervisory and 3+ years bio/pharmaceutical manufacturing experience.
Fundamental understanding and experience with cleanroom environments, aseptic manufacturing principles, and general packaging operations.
Technical Skills and Competencies
Demonstrated ability to supervise, train, and positively influence employees to meet defined objectives and daily production schedules.
Demonstrated ability to lead and interact effectively as part of an interdisciplinary team.
Demonstrated ability to hold oneself and others accountable to goals/objectives and team values.
High integrity and self-motivation.
Strong ability to multi-task.
Strong communication (oral and written), interpersonal, and team/group interactive and leading skills.
Strong commitment to product quality, customer service, and continuous improvement.
Ability to resolve technical issues, troubleshoots manufacturing processes, and investigates process deviations/excursions.
Demonstrated ability to effectively lead/develop others and optimize team performance.
Ability to represent department's interests with higher management and related groups (i.e. Materials Mgmt., HR, QA/QC, EMU, EHS, and technical support).
Strong computer skills.
Knowledge of 9CFR and current Good Manufacturing Practices (cGMPs).
Technical knowledge and/or expertise in microbiological techniques, sterilization, aseptic manufacturing, cleanroom behaviors, and validation principles.
Demonstrated understanding of SOPs, cGMPs, OSHA regulations.
Physical Position Requirements
Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards, continuous standing and lifting to a maximum of 50 lbs.
Normal hours are first shift; some off-shift and weekend work