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.

Job Summary

Supervises employees while assisting with the day to day activities in the manufacture of licensed, unlicensed reagents, and other liquid products in Cell Culture. Has substantial understanding of cell culture techniques and applies knowledge and skills to complete a wide range of tasks. Plans and maintains cell culture production ensuring a steady supply of materials for Werfen products. Supervises others and assists with the day to day activities for the Waukesha facility to ensure conformance to department, company, and FDA and ISO guidelines and regulations. Previous GMP or related experience preferred. Provides leadership to team players and manages their day-to-day activities enuring their and Werfen success.

Key Accountabilities

• Assures all production activities are being performed according to standard operating procedures.
• Assists in determining and planning departmental manufacturing schedule and schedules work to be performed by chemists in order to meet production needs.
• Performs evaluation, review, and revision of department’s standard operating procedures.
• Assists in the review of departmental records to include maintenance, cleaning, and manufacturing records.
• Lead and assist in training and cross-training activities and performs employee annual performance evaluations.
• Leads or assists with CAPAs, Change Controls, and Special projects/tasks as required.
• Lead triages for the department and initiate solutions to prevent issues from reoccurring.
• Show the utmost commitment to Quality and Safety at all times.
• 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

• This role will interact with R&D during the transfer of new cell lines to support new products
• This role will interact during investigaions with Manufacturing Technical Support to find root causes
• This role will interact with Quality Assurance during audits, NCRs, and CAPAs

Minimum Knowledge & Experience required for the position:

Education: Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience. Management has the discretion of substituting revalent work experience for a degree and/or making exceptions to the years of experience requirement.

Experience: 6 months to two years’ experience in Cell Culture or related area with previous GMP or related experience preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Must exhibit strong leadership skills and possess the ability to grow talent
• Experience in cGMP’s and FDA compliance
• Strong interpersonal, organizational, and communication skills
• Self-starter; ability to participate in cross-funcitional teams and influence others without direct authority
• Ability to set objectives and organize work to achieve goals
• Must be able to work within an evolving environment
• Must be able to accept change to work schedule on a daily basis
• Excellent communication skills, both oral and written

Travel requirements:

Minimal, if any travel requirement.

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