Primary Duties:

Delivers leadership and excellence in manufacturing processing and scheduling to meet sitedemands. Manages the floor operations to ensure safety and compliance with cGMPs are maintained at all times. Oversees the planning, implementation and maintenance of manufacturing operations for new and/or existing products and technologies in a cGMP environment. Collaborate with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Integrate best practices, where appropriate, into manufacturing. Ensures the efficiency of material, equipment and personnel in day to day operations. Monitor departmental operating expenses (OT, Equipment, Supplies) and assist in developing budgets.

Responsibilities: 
Processing:

Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs, and safety guidelines.Develop technical expertise in area of responsibility and provide technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnelWill monitor and control labor (absence, vacation and OT) and other group expenses.

People:

Responsible for interviewing and selecting candidatesProvide effective leadership through:Assess performance and make recommendations for annual programs such as Talent Review and Year End CompensationIndividual goal setting/performance reviewsEnsure appropriate staffing levels and skill sets are maintainedEffectively manage employee performance issues and corrective actionsEnsure the use of safe work practices and behaviorsRecognize and appreciate employee contributions and support workforce diversityEnsure that employees are working in a safe and compliant manner

Training:

Ensure that staff Individual Training Record (ITR’s) targets are metSchedule and track training attendanceEvaluate training effectivenessDay to day training and coaching employees

Quality:

Issue deviations or investigations of various complexities and work with cross-functional departments to evaluate root cause, close them and implement appropriate corrective actions.Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.Ensure operational metrics and business systems (ERP, Inventory) are maintained.Revise, author and review Standard Operating Procedures/Batch Records

Education and Experience Requirements:

Bachelor’s of Science degree and 2-4 years related industry experience or an equivalent level of education and/or related experience is acceptable.Experience as a Lead or Supervisor in a GMP Manufacturing facility requiredExperience in executing moderate to complex schedules preferredExperience with systems such as SAP, LIMS and TrackWise is a plus

Key Skills, Abilities, and Competencies:

Must possess effective leadership skillsOperational knowledge of aseptic technique, clean-in-place (CIP) and steam-in-place (SIP) and general biopharmaceutical production equipmentKnowledge of cGMP’s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.Good interpersonal skills and ability to work in a team environmentEffective communication skills throughout all levels of the organizationProven organizational and time management skills.Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.

Complexity and Problem Solving:

Responsible for technical problem solving, operational improvements, and efficiency improvementsProvide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.Demonstrated application in practical root cause analysis methodologies.Internal and External ContactsAdvises, consults and collaborates with cross-functional teams including but not limited to:Facilities and Engineering, Manufacturing Sciences and Operations Support, Quality, Validation, PMO Process Development and Health, Safety & Environment.