Operations Manager
PharmaBiotechRegulatory AffairsQuality Assurancegmpemacroraveinformsap
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 Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our Company's Animal Health is a BioTechnology 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 down-stream 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. Position Responsibilities: Supervision of facilities, equipment and personnel in the Cell Fermentation department, including coordination of additional labor, such as temporary employees or other departments Participate and support the Safe by Choice programs at the site. Lead safety by example Supervision of aseptic procedures including media preparation, antigen inoculation and harvest, tissue culture preparation and harvest, etc. Antigen storage and sampling for testing Review and revise processes and procedures against corporate and regulatory requirements to ensure 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 venders 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 department requirements Coordinate with Media, Blend, Filling, Central Services, Packaging and Planning personnel to maximize utilization of resources Coordinate resources between areas of production utilizing our Tier process to meet scheduling requirements Provide training, coordinate problem solving issues with Third Party Communicate and track critical component issues and work with venders 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 SAP and data base 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 Participate in KATA’s and KAIZEN’s for our continuous improvement program Lead Tier 1 communication meetings and provide input into Tier 2 and Tier 4 level meetings Education Requirement: High School diploma or equivalent with six (6) years of relevant leadership experience within a manufacturing environment or military service or five (5) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills OR Associate's degree with four (4) years of relevant leadership experience within a manufacturing environment or military service or three (3) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills OR Bachelor’s degree with either four (4) years of relevant experience in manufacturing or military service or two (2) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills Required Experience and Skills: Five (5)+ years of relevant work experience within a manufacturing environment One (1)+ years of experience in a leadership capacity. Proficient in Microsoft Office Strategic and effective communication skills High analytical and logical problem-solving abilities Strategic and optimistic teambuilding skills that focus on mentoring and coaching Preferred Experience and Skills: Experience working within vaccine and/or pharmaceutical Industry Working knowledge of USDA/GMP Guidelines Working knowledge of aseptic techniques and aseptic filling operations Strong knowledge of cell culture processes, bioreactors, and process equipment Working knowledge of SAP (operating system) #MSJR Required Skills: Adaptability, Aseptic Manufacturing, cGMP Compliance, Data Analysis, Employee Performance Standards, Interpersonal Relationships, Inventory Management, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People Leadership, Process Engineering, Process Improvements, Production Scheduling, Sterile Filling 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 <
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