Operations Manager

Merck•Millsboro, DE

34d•Hybrid

About The Position

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our Company's Animal Health is a BioTechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With expertise in mammalian, insect and avian cell culture production (anchorage & non-anchorage dependent), live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production and down-stream processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including poultry, equine, swine, bovine and companion animal.

Requirements

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

Nice To Haves

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)

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