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 and cell and gene therapies. 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.
The Senior Manager, Engineering, Capitol Projects manages all assigned capital projects in support of Manufacturing’s growth initiatives at AGC Biologics. This position is responsible for managing capital projects in an effective and efficient manner, ensuring on-time delivery for assigned capital projects, while managing changes such as capital project expansion, scope/schedule/budget changes, providing impact analysis. This individual will be responsible for scheduling, training, mentoring and performance appraisals for a staff of technicians within the engineering department. This position will report directly to the Site Head of Engineering and will be a leadership role within the organization.
- Manage active capital projects, ensuring capital projects are delivered on time and within the budget.
- Direct staff management of engineering technicians.
- Develop and oversee capital project construction standards and schedules, ensuring compliance; resolve any capital project issues/resource constraints affecting the capital project, with assistance from upper management.
- Prepare, review, and approve vendor scopes of work and proposals/RFP’s.
- Work with suppliers and vendors for capital projects to review and receive quotes.
- Manage all contractors and internal staff assigned to capital project.
- Manage all associated client deliverables.
- Participate in contractor conflict resolutions and disputes; implement corrective measures as necessary.
- Manage client expectations efficiently, with minimal guidance, while maintaining strong working relationships with all client representatives.
- Support day-to-day coordination of all phases of construction development and build out.
- Ensure fiscal accountability and account management including managing cost estimates, budgets, and certification of payments.
- Serve as liaison with Engineering, Quality and Manufacturing, consultants and contractors, ensuring capital project needs are met with minimal disruption and delay to day-to-day activities.
- Coordinate all capital project activities to minimize impact to departments and programs.
- Develop/maintain team dashboard.
- Collaborate with internal partners to build a comprehensive framework and track progress.
- Manage/resolve planning and scheduling conflicts with the capital project team and production.
- Maintain all capital project records; provide routine project and budget status reports, ensuring timely completion and submission of all required paperwork, approvals, project updates, etc.
- Assess resources required and resolve cross-functional conflicts.
- Develop capital project objectives working with user requirement and business plans.
- Provide regular capital project performance/updates to site leadership.
- Communicate issues or risks in a timely and effective manner; develop contingency/mitigation plans to address/resolve complex issues.
- Ensure all capital project close-out activities are completed, including identification of lessons learned.
- Drive operational excellence and continuous improvement.
- Other duties as assigned by AGC Biologics.
KNOWLEDGE, SKILLS & ABILITIES:
- Demonstrated deep understanding of cGMP Manufacturing and FDA regulations.
- Demonstrated experience providing project leadership and oversight in a highly regulated or pharmaceutical and/or biotech facility.
- Demonstrated proficiency in computer software applications such as Microsoft Project, Excel, Word required; experience with Computer Aided Design, e.g. AutoCAD, BIM, Revit Com preferred.
- Knowledge of current best practices, principles and standards of engineering, architecture, construction methods, procedures and policies associated with construction project management.
- Demonstrated ability to work independently and in a fast-paced environment.
- Excellent written, verbal, and interpersonal communication abilities.
- Demonstrated ethics, integrity, and sound professional decision-making skills/judgment.
- Ability to establish and maintain positive working relationships with colleagues, clients, contractors and staff.
- Must demonstrate high energy level, enthusiasm, initiative, flexibility, and the ability to meet deadlines.
- Knowledge of Quality by Design, Six Sigma or other operational excellence tools used to create efficient and high quality processes and end products.
- Strong technical writing ability required.
- Degree in Engineering/Biotechnology/related science or Project Management required; equivalent combination of education and experience (12+ years) in commercial capital construction management may be considered.
- Minimum of 12+ years' experience in Project Management, Capital Projects, Engineering, Construction and/or Architecture required.
- Minimum of 12+ years' experience working in GMP environment and bioprocesses, or pharma required.
- Experience in the development, automation, and manufacture of gene therapy products, biotech or pharmaceutical products, medical devices, instruments, or biotechnology required.
- Experience developing process layouts, production layouts and capital improvement projects required.
- Equivalent education and experience may substitute for stated requirements.
$121,844 - $159,615
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any
other characteristic protected by applicable laws, regulations and ordinances