Description

To assist Team Leader and Manager, in the production of biological products to meet cGMP requirements and marketing demands, and assist in monitoring and evaluating production process performances.To analyze production processes for the benefit of more predictable results, troubleshoot and identify production performance issues.To assist in the development of a continuous improvement philosophy within the work force.To assist in maintaining high production through put with high production performance goals.To assist in implementing process improvements within the Antigen Production, Unit 2 DepartmentAs an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Assist in the preparation and maintenance of the production seed developed in bioreactors
• Analyze Production culture performances by implementing and maintaining a biochemical analysis data base, implement new analytical tools to assist in measurements that aid in the performance of potency, sterility and stability of viruses, analyze bioreactor trend performances such as but not limited to SCADA information and data collection information.
• Assists in the Transfer and Implementation of new products or product improvements through the preparation of protocols, analytical tools and controls. Also, support the Management staff in the training of Production Operators during such transfers.
• Assist in troubleshooting production performance issues such as but not limited to potency, inactivation, stability and contamination. Evaluate trends in performance and recommend solutions. Prepare reports and assist in Unusual Occurrence Investigation for Production Management. Assist in implementation of corrective and preventative actions.
• Monitors Production Operator aseptic processing for Bioreactor area with regard to compliance to procedures. Evaluate improvements for implementation.
• Prepare reports on data collected from production runs and seed performance.
• Evaluate production medias and serums for growth of cell cultures in bioreactors and potency performance. Assist Production Management investigate decisions and procedures for the necessity of refeeding cultures for infection. Assist Management with the evaluations of processes to cut costs and stream line processes.
• Abide by and enforce the articles of the Bargaining Unit Contract.
• Write and review SOP's, Process Records, Quality Standards, Change Controls, Unusual Occurrences, and other reports as required. Maintain accurate and timely completion of records
• Assist in implementing BPE initiative within the Department.

Requirements

• Must have a degree from an accredited institution in Scientific Discipline - Microbiology, Chemistry, Engineering, or Biology
• Detailed working knowledge of applicable portions of cGMP guidelines, 9CFR, and production outlines.
• Technical knowledge normally attained by undergraduate courses in microbiology, biology, ' chemistry.
• Work experience must include tissue culture and virus propagation.
• Written and verbal communication skills with individuals inside and outside the company, as well as vertically and horizontally within.
• Ability to interpret and analyze technical data for evaluating results and solving problems.
• Ability to train and utilize hourly workers in a technical environment.
• Physical Demands / Surroundings
• Ability to work in gowned environment / clean room areas
• Visual Demands
• Ability to use microscopes and analytical tools such as but not limited to Fluorecscent microscopy, ELISA, and other spectrophotometric other colormetric tools
• Temperaments/Mental Requirements
• Ability to work under conditions where incubation of cell culture resides or movement of seeds in respective frozen storage conditions
• Level of Proficiency
• A minimum of a bachelor degree in Microbiology or Biology required.
• Attendance / Schedule
• Ability to adapt schedule to production needs to evaluate processes

Desired Skills, Experience and Abilities

PDN-9ef6109f-d69e-4a2b-8e93-f33a12aff0b5