Manager, Operations
PharmaRegulatory AffairsQuality Assurancegmpemacroraveinformsap
Job description
Job Description Job Description: For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Company's Animal Health group in Millsboro, DE is a Bio-Technology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With expertise in mammalian, insect and avian cell culture production (anchorage & non-anchorage dependent), live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production and downstream processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including poultry, equine, swine, bovine and companion animal. This position is responsible for managing materials entering the manufacturing area and waste exiting. The position also includes responsibilities overseeing the preparation, usage and storage of sterile tanks. The area manager ensures all schedules are met while following all safety and standard operating procedures to meet company product quality standards. Primary Responsibilities: Supervision of facilities, equipment and personnel in Central Services Area, including coordination of additional labor, such as temporary employees or other departments Review and revise processes and procedures against corporate and regulatory requirements to insure compliance Review production records for completeness and compliance to departmental and/or site SOPs Provide training to personnel to stay current with all regulatory agencies and corporate policies Evaluate personnel and machinery requirements and make and/or implement recommendations for changes and improvements Participation in daily activities to understand requirements and issues Provide guidance to personnel to maximize throughput while meeting regulatory requirements Coordination with vendors to determine equipment options Assist in the procurement and installation of new equipment Provide effective solutions to projects with a high level of technical difficulties and internal constraints Scheduling and planning for TCP requirements Coordinate with blend, filling, packaging and planning personnel to maximize utilization of resources Coordinate resources between areas of production utilizing our tier process to meet scheduling needs Provide training, coordinate problem solving issues with third party Communicate and track critical component issues and work with vendors for resolution Ensure proper safety procedures, standard operation procedures and aseptic techniques are followed Review current practices and ensure employees meet or exceed current procedures and techniques Coordinate Systems Applications and Products (SAP) and database entry and the movement of finished goods and in-process products between facilities Including inventory movement and production key performance indicators Other duties as assigned, such as scheduling equipment maintenance, various trouble shooting and contribute as needed on cross-functional teams Required Education, Experience and Skills: High school diploma or equivalent required. AS/BS in Life Sciences preferred. At least Five (5) years relevant experience in manufacturing; vaccine and/or pharmaceutical industry preferred At least two (2) years’ experience in a leadership capacity (supervisory or lead position) Working knowledge of the United States Department of Agriculture (USDA)/Good Manufacturing Practices (GMP) Guidelines Proficient in Microsoft Office Excellent communication skills High analytical and logical problem solving abilities Excellent Team building skills that focus on mentoring and coaching Working knowledge of aseptic techniques and aseptic filling operations preferred Strong knowledge of blending, filling and packaging materials, principles, and operating systems preferred #MSJR Required Skills: Adaptability, Adaptability, Aseptic Manufacturing, cGMP Compliance, Communication, Data Analysis, Employee Performance Standards, Equipment Management, Equipment Ordering, Equipment Procurement, Interpersonal Relationships, Inventory Management, Logical Thinking, Manpower Planning, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People Leadership, Procedure Adherence, Process Engineering, Process Improvements, Production Reports, Production Scheduling, Regulatory Compliance, Safety Legislation {+ 10 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collect
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