Supervisor, Serum Bulk Manufacturing and Monoclonal Production at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Team Leadership, Employee Training, Scheduling, Inventory Management, Quality Assurance, GMP Compliance, GDP Compliance, Record Review, Change Control, Continuous Improvement, Cell Culture Maintenance, Filtration, Solution Dilution, Sterilization, Data Analysis, Statistical Inference

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Assist Manager, with overseeing the day-to-day operations of Serum Bulk Manufacturing and Monoclonal Production departments with a high degree of attention to detail to achieve quality, compliance, stability and predictability in manufacturing. These processes include, but are not limited to, training and developing of employees, coordinating and scheduling operations, cleaning and sterilization of containers used in production, processing raw material, dilution of solutions/diluents, dilution of final products, intermediate filtrations, and final filtrations. Within in the Monoclonal department, processes include, maintaining Hybridoma cell cultures according to established procedures. Performs subsequent testing and processing of culture supernates to intermediate material for further manufacturing use. Performs certain production tasks in a cleanroom environment in compliance with Good Manufacturing Practices and Good Documentation Practices. Responsibilities Key Accountabilities Provides Guidance to Serum Bulk Manufacturing and Monoclonal Production team members for daily manufacturing operations. Trains new Serum Bulk Manufacturing and Monoclonal Production team members and ensure that all team members maintain up to date training records. Performs evaluations and team development. Helps to maintain department morale and employee motivation in a positive work environment. Monitors and maintains inventory of required supplies, components, and raw material and ensures that the teams have materials needed for their processes. Assists in scheduling of special projects and validation activities within the department. Ensures calculations are correct for products. Performs review of all records completed by teams, as well as works in MasterControl performing updates and reviews. Works on Change Controls and other qualty records. Performs daily walk throughs of the areas to ensure that they are being maintained and follows the Continuous Improvement model. Performs other duties and responsibilities as assigned Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Works closely with other production (manufacturing) members and quality control, quality assurance, customer service, shipping, sales, and marketing staff. Qualifications Minimum Knowledge & Experience required for the position: Bachelor of Science Degree in related field required and/or equivalent type of experience required. Skills & Capabilities: Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to work with mathematical concepts, such as, probability and statistical interference, and fundamentals of plane, solid geometry and trigonometry. Ability to apply concepts, such as fractions, percentages, ratios and proportions to practical situations. Ability to apply common sense understanding to carry our instructions furnished in written, oral and diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Travel requirements: N/A Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

This role involves assisting the Manager in overseeing daily operations for Serum Bulk Manufacturing and Monoclonal Production, focusing on achieving quality, compliance, stability, and predictability in manufacturing processes. Key duties include training and developing team members, coordinating operations, managing inventory, performing record reviews, and ensuring adherence to GMP/GDP standards, especially within the Monoclonal department's cell culture maintenance.