Operations Manager

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• Supervision of facilities, equipment and personnel in the Filling and Freeze Drying 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
• Responsible for preparing and approving formulations for finished products
• Supervision of aseptic procedures including media preparation, antigen inoculation and harvest, tissue culture preparation and harvest, filling vaccines, etc.
• Antigen storage and sampling for testing
• 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 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 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 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

• 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

• 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

• 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 blending, filling, freeze drying and packaging materials, principles, and operating systems
• Working knowledge of SAP (operating system)

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.

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