Director, Vaccine Production

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 several 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.

The Director, Vaccine Production provides technical and strategic leadership that drives end-to-end integration and facilitation of the timely manufacture of quality vaccines by ensuring that schedules, plans, equipment, and resources are horizontally and vertically integrated within vaccine production and filling areas to optimize cost, quality, delivery, and compliance requirements. This role is also responsible for driving a culture of continuous improvement which delivers year-on-year improvements in yield, process reliability and supply performance.  Hires, leads and develops talent to ensure fulfillment of critical positions within Operations.

The Director, Vaccine Production optimizes organizational structure and value chain processes and drives continuous improvement activities. This position may serve as the interim deputy in the designated deputy's absence.

Duties & Responsibilities

• Leads and provides direction to vaccine manufacturing and aseptic filling functions to assure supply and enhance performance related to cost, quality, delivery/supply, process and compliance in the production of vaccines to be distributed both domestically and internationally.
• Provides technical leadership for issues relating to the manufacture of current products, new product development and product launch.
• Develops and implements the appropriate teams, procedures, and metrics to ensure the successful execution of new product initiatives transferred into manufacturing.
• Drives the implementation of a continuous improvement culture through thoughts, deeds, actions, BPE, and process development yield and reliability improvement projects.
• Establishes best practice sharing between sites and compares with external benchmarks.
• Provides leadership and direction for process optimization efforts relating to cost, quality, delivery, process reliability, yield and compliance for both current and new products.
• Prepares the expense and head count budgets for the manufacturing and filling functions of the assigned site.
• Effectively communicates CapEX requirements for manufacturing facility based on the BI AH and global AH business plans and strategies.
• Provides oversite of Bills of Materials and routings to reflect production processes, minimizing yield usage and conversion variance.
• Ensures the qualification and maintenance of the department, premises and equipment and that appropriate validations are completed as required.
• Develops a highly competent and appropriately aligned organization including a strong management team, through a combination of individual development, external hiring and motivating high quality personnel.
• Champions the development and performance management of all employees to include succession planning and career development.
• Ensures that the required initial and continuing training of the department personnel is completed on time and that training is adapted according to need.
• Provides strategic oversight for approval and implementation of the procedures and instructions relating to production operations to ensure that products are produced and stored according to the appropriate documentation to obtain the required quality.
• Ensures that the production records are evaluated and signed by an authorized person.
• Drives year on year tech agenda that delivers enhanced site supply and financial performance.
• Responsible for deliverables achieved through direct oversight and application of scientific guidance for the process development (MSAT) scientific team and production functions result in year-on-year reductions in destructions and improvements in process reliability through process understanding.
• Applicable site is responsible for stable supply of ≤ 90 antigens and anywhere from 175 - 650 product skus.

Requirements

• Bachelor’s degree with a minimum of ten (10) years progressive experience and a broad range of experience and technical competence in veterinary/vaccine production.
• Ten (10) or more years of Leadership experience.
• Five (5) years’ experience working with business process excellence concepts such as Lean.
• Experience driving improvement in yield and process reliability in vaccine production space.
• Data driven decision making and smart risk taking.
• Change agent with proven record of instilling culture of continuous improvement.
• Must demonstrate proficiency in applicable global regulatory requirements including EU, cGMP, 9CFR.
• Six Sigma or Lean manufacturing practices required. Six Sigma Green belt desired.
• Prior experience in process development is desired.
• Experience working collaboratively in a matrix environment is preferred.
• Must possess a working knowledge of all business disciplines to ensure ability to “partner” with all functional departments of the organization.
• Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent communication skills, team player, organized analytical thinker with a high level of energy and self-motivation, excellent writing skills.
• Strong scientific and technical background and experience in all areas in the Biotech and Pharmaceutical industry desired.
• Ability to develop and maintain strong working relationships with internal and external; global and regional; regulatory and governing bodies.
• Demonstrated versatility in conflict resolutions, problem solving, and working effectively as a part of a cross functional team.

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).
• Must be 18 years of age or older.