• 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 through-put 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

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

Adaptability, Adaptability, Aseptic Manufacturing, Aseptic Technique, Biomanufacturing, Cell Cultures, cGMP Compliance, Data Analysis, Employee Performance Standards, Employee Scheduling, GMP Compliance, Interpersonal Relationships, Inventory Management, Leadership, Maintenance Troubleshooting, Mammalian Cell Culture, Management Process, Manufacturing Quality Control, Operational Excellence, Operations Management, Packaging Operations, People Leadership, Process Engineering, Process Improvements, Production Management {+ 5 more}

$94,300.00 - $148,500.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.Company.com/us/en/compensation-and-benefits

No relocation