Responsible to manage, plan direct and coordinate the general operations of the Research Grade manufacturing service level supporting the Aldevron-Fargo site. The position has key responsibility and oversight for operational functions of the site to include RG Production and support personnel. At this level, the position has a direct contribution to the development of functional strategies and responsibility for managing multiple teams. The Director, Biomanufacturing-RG is to assure that the site stays on schedule with regard to production and shipping, meeting the demand/revenue targets, and profitability measures to meet or exceed the organizational goals.
Essential Duties and Responsibilities:
- Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables, site metrics and company goals.
- As appropriate, coordinate and lead process improvement implementation for area of responsibility
- Interface directly with clients to provide RG manufacturing informational updates.
- Serve as subject matter expert during client visits and new project set ups. Collaborate with site management to address any follow-up actions.
- Oversee, lead and direct all manufacturing activities for RG service level to ensure products are manufactured, packaged, shipped and stored according to procedures in support of the manufacturing forecast, in compliance with all internal and client requirements.
- Accountable for identification of gaps, remediation and developing action plans for the implementation of systems to meet short and long term manufacturing goals.
- Responsible for maintaining a smooth flow of work between departments. Keeps priority on key metrics related to RG service levels operational efficiencies and capital/resource utilization.
- Provide leadership and direction to the organization's objectives.
- Partner with Process/Product Development, for the design and implementation of high yielding production processes with high success rates and minimal process investigations or discrepancies.
- Ensures plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
- Point person for technical issues and liaisons with internal groups to facilitate issue resolution.
- Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations and procedural error. Support strategic plans for process and facility improvements in order to increase efficiency and manage costs.
- Accountable for results in terms of overall operation costs and budgets, efficiency, productivity, continuous improvements, all measured through various metrics including yields, throughput efficiencies, labor and material costs and variances.
- Actively participate in process and product development/optimization, scale-up and tech transfer.
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.
- 5-7 years of progressive experience in a biotechnology or pharmaceutical manufacturing environment.
- A proven track record of technical accomplishments with strong practical knowledge of the technologies related to manufacture of Aldevron products, automation, validation and process/product engineering
- Bachelor's degree in science required
Skills and Knowledge:
- Excellent organizational, supervisory and leadership skills to manage a team of manufacturing staff.
- Proven multitasking skills and ability to work under pressure.
- Excellent written and verbal communication skills
- Above average organizational skills
- Excellent interpersonal skills
- Ability to effectively organize and work in a fast-paced, deadline-driven work environment.
- Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally.
- Ability to manage competing demands
- Ability to work in a fast, efficient environment with cross-functional teams
- Strategic expertise with an action oriented perspective, sound problem analysis and logical thinking, with the ability to develop investigational plans.
- Adept at problem solving
- Adapts to changes in the work environment
- Experience in budgeting, tracking costs, analysing data and developing action plans
- Willingness to perform "hands-on" work in dynamic work setting
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.
This position may work in a lab setting and may come in contact with various solutions and chemicals, and will be responsible for activities related to biological processes such as bacterial growth. This position uses standard laboratory equipment such as pipettes, centrifuges, glass ware, shake flasks, fermenters, fume hoods, and computers.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.