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Manages staff in the formulation of specialized and rare reagents needed to meet the Immunodiagnostics Manufacturing productionschedule.Schedules and oversees all activities occurring in the Reagent Support Manufacturing Department, including product transfers from R&D,troubleshootingproduct failures, and product improvement efforts.
Essential Duties and Responsibilities:
- Directs and coordinates daily activities of Reagent Support Group
- Plans and schedules manufacturing to assure reagent availability to meet production requirements
- Directs the formulation of chemical reagents from stock
- Manages direct reports and performs performance assessments
- Oversees all recruiting and retention efforts
- Insures all current and incoming staff members are current in training requirements
- Administers corporate policies and insures adherence to by staff
- Develops and executes annual departmental budgets, including staffing, capital, and operating expenses
- Assist in troubleshooting quality problems using experimental design and the MEMO program
- Make recommendations for improvements to existing products based on experimental and stability data
- Participate in product/process improvement of current products to improve product quality, reduce lead-times, and improve costs
- Oversees productivity and efficiency metrics and participates in continuous improvement efforts
- Participate in alternate raw materials, grades, or supplier validations
- Manages the empirical evaluations for chemical and antibody reagents
- Manages the antibody inventory and ensures all projects are initiated in a timely fashion to prevent shortages
- Prepare and present reports and analysis of data as required
- Develops, executes, and maintains documentation and work instructions to meet current cGMP / ISO / MIOSHA / MDEQ or other regulatory requirements
- Coordinate new product transfers into manufacturing including implementation of BOM’s, work instructions, etc.
- Assist in the establishment of Q.A. and Q.C specifications
- Oversees the organization and cleanliness of the department
- Maintains general cleanliness and organization of physical area responsible for
- Other duties as may be assigned by Management
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience: Minimum BS degree in Biochemistry, Chemistry or Biological Science. Minimum five years of related Supervisory, Laboratory and Manufacturing experience including HPLC and FPLC analysis, protein purification and characterization, and protein conjugation. Knowledge and understanding of cGMPs and ISO desirable.
Language Skills: Ability to read, interpret and understand documents such as safety rules, operating and maintenance instructions and procedural documents in English. The person must be able to read computer screens in English. Ability to speak effectively in front of team members and in front of other general group meetings.
Mathematical Skills: Ability to perform routine, college level mathematical operations, including basic statistical functions.
Computer Skills: To perform this job successfully, an individual must have a solid knowledge of computers and OS systems as well as the ability to effectively communicate electronically. Knowledge and experience with Microsoft Office Suite is also required.
- Troubleshooting – Takes an analytical logical approach to determine the root cause of problems and devises a solution to the problem. Records, presents and interprets data in a clear concise organized manner. Utilizes the scientific method.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Oral Communication – Can speak clearly and persuasively in both positive and negative situations; listens and gets clarification as required; responds effectively to questions; can effectively manage group presentations; will be an active participant in meetings.
- Written Communication - Writes clearly and informatively; varies writing style to meet needs of readers; presents numerical data effectively.
- Cost Aware - Works within approved departmental budgets; can develop and implement cost saving or avoidance measures; conserves organizational resources; contributes to profit.
- Ethics – Treats people with dignity and respect; keeps commitments; inspires the trust of others; works with integrity and ethically; upholds organizational values; maintains confidentiality.
- Organizational Support – Will follow and support corporate policies, procedures and decisions once made; completes necessary administrative tasks correctly, effectively and on time.
- 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.
- Planning/Organizing - Prioritizes and plans work activities; can utilize time efficiently; develops realistic action plans and does follow up as needed.
- Professionalism - Approaches others in a tactful manner; reacts well under pressure/stress; treats others with respect and consideration regardless of status or position; accepts responsibility for own actions.
- Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions.
- Delegation – Can effectively and reasonable delegate to staff to achieve goals.
- Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
- Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests;
- Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles.
- People Management – Must be able to manage a diverse workforce with varying levels of education and training effectively; demonstrates knowledge of EEO; promotes a harassment-free environment, can mentor and coach effectively.
- Business Acumen – Understands business terminology; business implications of decisions; displays orientation towards profitability; aligns work with strategic goals.
Physical Demands: The physical demands 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.
While performing the duties of this Job, the employee is regularly required to see, talk and hear. The employee is frequently required to stand, walk and sit, for prolonged periods of time. The employee is required to use hands to handle or feel; reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close visual acuity (with or without corrective devices), depth perception and color vision.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles (dust), wet floors, cold or hot areas. The employee is occasionally exposed to toxic, pathogenic or caustic agents that require the use of specific PPEs. The noise level in the work environment is usually moderate to high.
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