Operations Manager

** Position*
* ** Responsibilities
* ** 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
* 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)
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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