Description

Manager, Biological Production

The basic purpose of this position is to provide administrative and technical direction in Biologics Production according to company policies and corporate business plans, to provide technical competence through proper selection and training of the staff and the workforce, to ensure a safe work place through proper training of staff and the work force to implement and maintain compliance status (cGMP, OSHA) within the department, to implement strategies to reduce cost of goods and improve existing production processes. The incumbent will represent their assigned interest to the business contacts (customers, suppliers, etc.) inside as well as outside BI and serves as a backup to the Director, Vaccine Production or direct supervisor in the event of their absence. 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 several 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.

Group Leader, Antigen Production

Assist Associate Director / Manager in all phases of Antigen Production. Produce biological products in a timely manner to meet marketing demands, as directed, monitoring the production process (fermentation, harvesting, processing, blending), and evaluating results. Assist in assuring technical competence through proper technical training of work force. Insure a safe work place through proper training of workforce. Assist in developing a continuous improvement philosophy within the work force. Implement new technologies. Assist in maintaining the lowest cost of production possible. 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, 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

Manager, Biological Production

• Direct and supervise assigned areas in order to manufacture high quality biological products.

• Assist in coordinating the transfer of new products from Process Development into Production and in manufacturing qualifying/validation serials.

• Troubleshoot production problems, document findings, and implement solutions to resolve problems

• Train personnel in scientific principles, time management, GMPs, technical requirements, and all other policies and regulations governing the production of biological operations.

• Communicate to management progress of the department, problems, employee actions, new ideas, and all other pertinent information.

• Administration of company policies and safety programs.

• Interface with other department managers and employees in a professional manner to coordinate the activities and issues.

• Prepare annual departmental budget and monitor departmental expenses and capital projects.

• Complete annual review of all production outlines, special outlines, etc.

• Participate in and/or chair appropriate meetings and committees as assigned.

Group Leader, Antigen Production

• Schedule the production of necessary intermediates for the timely completion of products.

• Familiarize self and train work force in cGMP, APHIS, and OSHA regulations pertaining to production processes.

• Troubleshoot production problems, document findings, and implement solutions.

• Develop new production methods to reduce cost and improve quality.

• Maintain accurate government and in-house records.

• Write and review production outlines, SOP´s and other reports as required.

• Assist Biological Research with special problems and projects pertaining to new biological products and biological combinations.

• Acts as a back up (deputy) to Associate Director, Antigen Production.

• Establish and control appropriate manufacturing process documentation according to GMP manufacturing records requirements.

• Abide by and enforce the articles of the Bargaining Unit Contract.

Requirements

Manager, Biological Production

• BS in related discipline with minimum 4 years of experience in related field and minimum 2 years previous leadership experience required; minimum of 5 years´ experience preferred.

• Effective interpersonal skills with a diverse group of individuals at all organizational levels

• Proficiency in relevant computer software and programs associated with area.

• Excellent written and verbal communication skills

• Experience in biological production environment. Technical knowledge of biological production equipment and all biological operations necessary to produce high quality biological products. Excellent management, verbal and written communication, coaching and teamwork skills. Ability to lead teams to achieve results.

Group Leader, Antigen Production

• Bachelor´s Degree in related business or scientific field from an accredited institution and a minimum of four (4) years of experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment.

• In lieu of a Bachelor´s degree, a minimum of ten (10) years of experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment can be utilized.

• Experience must be inclusive at least three (3) years leading people and/or moderate to complex process improvement and related production projects.

• 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.

• Experience in ERP inventory control system(s) is preferred but not necessary.

• 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.

• Demonstrated knowledge of Aseptic or related production techniques and equipment.

• A working knowledge of cGMP, EU and OSHA Part 11 guidelines as they pertain to implementing process improvements on aseptic production or other production equipment.

• 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.

• Must be able to readily learn and quickly become proficient in all software applications utilized for packaging equipment and operations.

Desired Skills, Experience and Abilities

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.