Manufacturing Manager

Summary of purpose/major responsibilities Provide the leadership, direction, and the overall oversight of the BSA Operations at Biological Services Area during 3rd shift (10 PM to 6:30 AM). This position is responsible for development of technicians as well as ensuring quality, safety, budgeting, and inventory control of the drug substance manufacturing operation. Key accountabilities List the 6-8 most important responsibilities of the job. For each key responsibility indicate the action to be taken, the end result to be achieved, and how it will be achieved. Include the % of time spent on each responsibility. Total of percent should equal 100 %. Key Accountability % of time Provide leadership and direction to the operational staff.  This includes providing feedback on their performance as needed as well as during monthly one on one meeting.  Responsible to ensure staff development needs and provide support and accountability for achieving results, and KPI's in a GMP environment as well as for professional development. Ensuring a high level of engagement of all direct reports to align and support organization objectives and LEAD Competencies (the "How" we work).  20% Provide leadership and direction to ensure deviation investigations are initiated, reviewed and closed on time.  Provide support and direction to ensure CAPA's, Change Controls, internal audits items, and any other regulatory commitments are met on time.  Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality Requirements. 15% Provide leadership and direction on the shop floor to maintain the area is operating at the highest safety and quality standards. Complete HSE investigations and provide support for HSE CAPA's. Works to ensure that all technicians have what they need to complete their job compliant and in a safe manner 15% Provide leadership and direction to quality documentation on the shop floor.  This includes but not limited to reviewing and approving equipment printouts, logbooks, and temperature charts.  Also involves reviewing Batch Production Records (BPRs) in a timely manner in order to hit production targets. Additionally, review and approve quality documents and procedures. 20% Provide leadership and direction in regard to equipment, process improvement, and facility requirements from support systems.  Assist production employees through development of working relationships and strong communication links through all levels of the organization. Provides day-to-day support for the production floor to support completion of short-term projects needed to support the business side of production including production scheduling 15% Provide leadership and support to ensure there are departmental objectives and metrics to align with the vision of the site in the areas of safety, quality, cost, production delivery, continuous improvement, and employee development. Ensure appropriate staffing levels and maintain personnel scheduling. Ensure training goals and KPIs are met to provide functional production support.  Managing headcount and expenses in department to achieve site objectives and meet budget expectations 15% Context of the job/major challenges Highlight the most significant aspects of the environment that affects the job. Describe the most important problems to resolve to achieve the job's major purpose. Strong leadership and communication and interpersonal skills, time management. Commitment to personal and professional development. Adaptability in a changing work environment required to lead BSA manufacturing operations and develop the talent of the team.  Strong cross-functional working and technical skills be able to work with groups in all of Biologicals Manufacturing Physical Working Conditions Select the appropriate number that applies in the blank. Percent of Time:  1- (< 15%)   2 - (15 - 25%)     3 - (26 - 50%)       4 - (> 50%) Office Environment     Lifting: Specify # lbs:       1 Temperature Extremes 1 Uncomfortable Protective Clothing 1 Excessive Noise 1 Unpleasant Fumes 1 Dust or Dirt 1 Adverse Weather Conditions 1 Other (Specify) - Work in close proximity of chemicals and biological agents 1 List Hazardous Conditions: Dimensions/Scope Provide numerical data, if available, to describe the size of the job, or its impact on the business. Use annual figures and specify currency. Figures should include budgetary responsibility, purchasing authority, resources available. Highlight the key decisions made in this job. Outline the sphere of the job, such as whether the accountabilities are global, country specific, or function specific. Breadth of responsibility (global/regional/country/site): Swiftwater Site, Biological Services Area, Buildings 37, 46, 56, or 59 Responsible for timely supply of Equipment, Media, and Reagents for further downstream production of the vaccine Responsible for providing coaching, development, and leadership to a team of approximately 5 - 15 technicians.  There is also a shared leadership per shift with a team of >20 and across different departments within the same building. Key indicators on which the job holder will be evaluated (WHAT in 9box): Leading a shift that works in a 24 hour, 7 day per week operations to meet a demanding production schedule while exceeding the increasing requirements for quality and safety requires a high degree of flexibility and creativity. This role will be during 3rd shift (10 PM to 6:30 AM).  Supervision of all BSA technicians on a given shift. Decisions are made on highly complex matters involving technician feedback was well as proper communication to the Deputy Director as well the quality team and other support groups.  Decision typically affects more than one major segment of the Company and can only be reversed or modified at a high cost to the Company. Key Indicators: Safety Measures       Quality Measures     Delivery Measures   Cost Measures Personnel Measures  Involvement            Strategy Freedom to act, level of autonomy : Strong automony required to lead manufacturing operations. Requirements Basic Qualifications Bachelor's Degree in Life Sciences, Engineering or Management. A minimum of five (5) years' working in manufacturing, preferably a regulated environment. Knowledge of cGMPs and regulatory requirements are required.  Leadership and people management skills are required. Ability to work 3rd shift (10 PM to 6:30 AM). Preferred Qualifications A background in continuous improvement/CAPA implementation Previous experience with biologic manufacturing and firm understanding of equipment associated with their manufacture.  Involvement with Regulatory Agency inspections including shop floor tours and documentation audits Demonstrated customer focus through meeting commitments and deadlines Demonstrated ability to build networks and relationships at various organizational levels with strong interpersonal skills Ability to learn and understand complex processes quickly, then explain those processes with ease to various internal and external audiences with level appropriate detail Strong technical and leadership skills required to lead production team Strong cross-functional working skills to cut across organizational boundaries within and outside of Biologics Manufacturing. job id R2479838
Salary Range: NA
Minimum Qualification
5 - 7 years

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