at Merck in Millsboro, Delaware, United States
Our Animal Health Manufacturing Operations team is looking for an Operations Manager to join the team in Millsboro, DE.
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.
Responsibilities include but are not limited to:
+ 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
Education Minimum Requirement:
+ 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
Required Experience and Skills:
+ At least five (5) years of relevant experience in the vaccine and/or pharmaceutical Industry.
+ Demonstrated leadership skills.
+ 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.
Preferred Experience and Skills:
+ A minimum of one (1) year of experience in a leader capacity (supervisory or lead position).
+ Working knowledge of aseptic techniques and aseptic filling operations.
+ Working knowledge of SAP (operating system).
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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