Merck
Operations Manager
Millsboro, DE | $116K - $154K
Qualifications
- High School diploma or equivalent with three (3) years of relevant leadership experience within a manufacturing environment or military service or two (2) years’ experience in a direct GMP, biotechnology manufacturing setting with demonstrated leadership skills
- OR Associate degree with two (2) years of relevant leadership experience
- OR Bachelor’s degree with one (1) year of relevant leadership experience
- At least five (5) years of relevant experience in the vaccine and/or pharmaceutical Industry
- Working knowledge of USDA/GMP Guidelines
- Strong knowledge of biological virus propagation, bioreactor fixed and mobile principles, and operating systems
- Proficient in Microsoft Office
- Excellent communication skills
- High analytical and logical problem-solving abilities
- Excellent team-building skills that focus on mentoring and coaching
Responsibilities
- This position is responsible for managing a team who of biological production technicians within the Bio Processing Department / Lab
- This position will ensure that production schedules are met in accordance with all safety procedures and standard operating procedures to meet company product quality standards
- Supervision of facilities, equipment and personnel in the Bio-Processing department (may include occasional weekend work)
- This would include coordination of additional labor, such as temporary employees or other departments
- Participation in and support of the Safe by Choice programs at the site
- Lead safety by example
- Maintaining an accurate and sufficient viral seed inventory allowing for the uninterrupted production of animal health vaccines
- 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
- Reviewing and revising processes and procedures against corporate and regulatory requirements to ensure compliance
- Reviewing production records for completeness and compliance to departmental and/or Site Standard Operating Procedures (SOPs)
- Providing training to personnel to stay current with all regulatory agencies and corporate policies
- Evaluating personnel and machinery requirements and making and/or implementing recommendations for changes and improvements
- Participation in daily activities to understand requirements and issues
- Providing guidance to personnel to maximize through-put while meeting regulatory requirements
- Coordination with vendors to determine equipment options
- Assisting in the procurement and installation of new equipment
- Providing effective solutions to projects with a high level of technical difficulties and internal constraints
- Scheduling and planning for department requirements
- Coordinating with Media, Blend, Filling, Central Services, and Planning personnel to maximize utilization of resources
- Coordinate resources between areas of production utilizing our Tier process to meet scheduling requirements
- Providing training, coordinate problem solving issues with Third Party
- Communicating and tracking critical component issues and working with vendors for resolution
- Ensuring proper safety procedures, standard operation procedures and aseptic techniques are followed
- Reviewing current practices and ensuring employees meet or exceed current procedures and techniques
- Coordinating SAP and database entry and the movement of finished goods and in-process products between facilities
- Including inventory movement and production key performance indicators
- Participating in KATA’s and KAIZEN’s for our continuous improvement program
- Leading Tier 1 communication meetings and provide input into Tier 2 and Tier 4 level meetings
- Other duties as assigned, such as scheduling equipment maintenance, various trouble shooting and contribute as needed on cross-functional teams
- Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders)
Company information
