AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
AGC Biologics is seeking a Vice President of Engineering to oversee the strategy and execution of all facility/manufacturing engineering functions. This position will provide strategic leadership for the Engineering function including, but not limited to, capital projects, staff management and leadership. In addition, this position will ensure that maintenance processes & standards are developed, implemented and followed for all Engineering functions.
Provide leadership to a diverse group of talented engineers and technicians, developing methodologies to deliver on the infrastructure plans in a timely and cost effective manner, while adhering to safety, sustainability and quality.
Demonstrate leadership through coaching and developing staff, managing for high performance, attracting and retaining talent and communicating effectively to influence with impact.
Manage the development, delivery and execution of the Facilities Masters Plan projects through the management of a large capital budget; execute capital plans in a disciplined manner ensuring Master Plan objectives including budget, schedule, quality, safety and sustainability are met or exceeded.
Strategically develop a thoughtful, forward-looking Master Plan, maximizing the use of current AGC Biologics assets while developing plans with optionality factored in for future growth.
Oversee all plans, designs and estimates time and cost; oversee construction and maintenance of structures, facilities, systems and components.
Oversee the development and application of engineering standards and procedures; provides guidance on issues within the engineering function.
Create and execute on an Engineering roadmap that optimizes business processes including but not limited to design, construction, project controls and maintenance. For simplicity, adds systems for efficiency, and standardizes work functions for consistency.
Instill/ensure discipline in key areas such as Supplier/Partner selection and management, Knowledge Management, Capital Planning.
Set and manage to world class targets as they relate to EOS Metrics and Sustainability Operations.
Analyze current processes and approaches to EOS and Sustainability and develop a vision for world class performance within the biopharmaceutical sector.
Establish policies and procedures for engineering related matters, assuring management reporting through the development metrics and performance indicators to monitor and trend result, and taking actions to correct, prevent and/or improve execution and future performance.
Ensure effective and compliant operations in accordance with site registrations, cGMPS and environmental regulations and state requirements; acquire and maintain permits and certifications as necessary.
Effectively execute projects that improve quality and safety, reduce product cost and risk, and ensure efficient and effective plant production capabilities. This includes the development and preparation of required cGMP documentation required for the engineering and facility projects as well as the ongoing facility, equipment and utility maintenance programs.
Provides oversight to assure completion of all phases of a project in a timely and efficient manner, meeting or exceeding budget expectations.
Apply Lean and Six Sigma methodologies to drive process improvement.
Participate as a member of the site leadership team.
Other duties not listed in this description might be asked of this position.
KNOWLEDGE, SKILLS & ABILITIES:
Knowledgeable in the following systems: Compressed Air, Steam, Chilled Water, Pharmaceutical Utilities, Purification, Filling, Bioreactors, Automation, Sterilization, and Water Purification.
Demonstrated experience utilizing Lean and Six Sigma methodologies.
Excellent verbal and written communication skills.
Dynamic interpersonal skills, including the demonstrated ability to manage through influence.
Strong business skills including budget management experience.
Demonstrated planning and organizational skills including project management.
Proven knowledge of best practices as they relate to facility/process/manufacturing engineering.
Demonstrated expertise in mentoring/team development, change management, planning/organizing.
Demonstrated deep technical knowledge of facility/process/manufacturing engineering in a biotech/pharmaceutical environment.
Ability to work hours necessary to support the running of the site, inclusive of non-traditional work hours.
Ability to work on multiple projects and manage various priorities and timelines and to adapt quickly to changing circumstances.
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
Results oriented with the ability to demonstrate resiliency, ownership and drive.
BA or BS degree in a technical discipline (Engineering preferred) with a minimum 10 years of relevant experience; advanced degree in Engineering-related discipline preferred.
10+ years' experience leading capital projects and directing the Engineering function at an executive level ideally in a pharmaceutical manufacturing environment or related space.
Experience implementing or managing an effective technical group (Engineering, Manufacturing, and Technical Operations) discipline at a biotech/pharmaceutical company.
Six Sigma and PMP certification preferred.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
CMC Icos Biologics Inc.