Lead Technician – Cell Culture

Werfen•Waukesha, WI

4h•Onsite

About The Position

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.

Requirements

Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.
6 months to two years’ experience in Cell Culture or related area
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

Nice To Haves

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

Responsibilities

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.
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