Process Leader, Bio Production 2nd Shift Mon-Fri 3:00PM - 11:30PM

Boehringer Ingelheim Pharmaceuticals, Inc.; Missouri; On-site; USD 95,000 - 125,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Missouri seeks a Process Leader for Bio Production on 2nd shift (Mon-Fri 3:00 PM to 11:30 PM). You will provide technical direction, ensure cGMP compliance, and lead a team in a fast-paced production environment.

You will manage batch records, SOPs, and budgets, drive continuous improvement, and collaborate cross-functionally to ensure safe, compliant, and reliable bioprocess operations.

Qualifications

• Bachelor's degree in related business or scientific field required or preferred with 2 years professional experience; 6 years experience in lieu of degree.
• Demonstrates ability to train others and perform OJT assessments.
• Experience with SAP/ERP systems and documentation control.
• Strong written and verbal communication; detail-oriented and able to manage multiple projects.

Responsibilities

• Supervise personnel and communicate department status and issues to management.
• Hire, train, coach and develop personnel; coordinate department activities and schedules.
• Prepare and manage departmental budget and monitor expenses and capital projects.
• Purchase operating supplies and coordinate inventory controls within production areas.
• Organize batch record reviews and maintain documentation for regulatory compliance.
• Create and review SOPs and forms to support change controls and regulatory initiatives.
• Provide KPI data and analysis to management; recommend improvements.
• Analyze production problems, document findings, and implement corrective actions.

Skills

Leadership experience

Training others

Process improvement

Communication

Attention to detail

Project management

MS Office proficiency

Education

Bachelor's degree in related field

Tools

SAP/ERP software

Database management

Microsoft Office

Job description

Process Leader, Bio Production 2nd Shift Mon-Fri 3:00PM - 11:30PM

Description

As 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Provides technical direction and supervision in their assigned biological production area according to company policies and corporate business plans. Ensures technical competence through proper selection and training of the work force, ensuring a safe work place. Implements and maintains compliance status (cGMP,OSHA) within the department. Manages the documentation flowing in/out of the production floor including, but not limited to, batch records, equipment logbooks, etc. Assist in developing a continuous improvement philosophy within the work force. Implement new technologies. Assist in maintaining the lowest cost of production possible.

Duties & Responsibilities

• Supervise personnel to include communicating to management the status and/or progress of departmental concerns, issues, employee actions, new ideas, and all other relevant information to ensure success within the department.
• Hire, train, coach and develop personnel within the department in accordance with polices and procedures.
  Coordinate the activities and schedules of the department.
• Prepare and/or manage departmental budget and monitor departmental expenses and capital projects.
• Responsible for purchase of operating supplies to include recommendations new or replacement equipment. Coordination of cycle counts in the Department to control inventory in production areas.
• Accurate business function documentation management: Organize/prioritize batch record reviews as defined by Management for completed production items.
• Create, review and approve relevant SOPs, Controlled Forms and other business function documents to support regulatory compliance, change controls and company driven initiatives.
• Manage and maintain tracking system for department key performance indicators. Provide data/metrics to Management regarding individual, equipment, production trends; provide recommendations to resolve errors.
• Analyze production problems, document findings, and implement solutions to resolve problems
  Investigate production process deviations.
• Ensure compliance with cGMP, APHIS, OSHA, EPA, EU, and JP regulations pertaining to production process.
• Direct engagement in process execution including performing, supervising and supporting process steps ensuring safe, compliant and reliable outcomes.

Requirements

• High School Diploma. Bachelor's Degree in related business or scientific field preferred.
• In addition to Bachelor's degree, 2 years professional experience. 6 years relevant experience in lieu of degree. Experience must be inclusive of 1 year leadership experience.
• Demonstrated ability to train others and complete OJT assessments.
• Demonstrates the ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
• Experience must be inclusive of managing and auditing master receipts, batch records and process order data within relevant SAP/ERP software systems.
• Experience with word processing, spreadsheets, and database management required.
• Must be detail oriented, able to work with minimal supervision and self-motivated to utilize resources to troubleshoot as needed.
• Ability to manage multiple on-going projects with aggressive deadlines.
• Strong proofreading skills along with excellent communication and written capabilities.
• Must be proficient in MS office applications such as Word, Excel, Outlook, etc.
• Experience in ERP inventory control system(s)is preferred but not necessary.
• Must be able to readily learn and quickly become proficient in all software applications utilized for packaging equipment and operations.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)