Senior Manager, Facilities (23026-B-850-FAC)
Hayward, CA, USA
Posted on Tuesday, May 2, 2023
ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Senior Manager, Facilities to work onsite based in our Hayward office.
ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer, and prioritize the team’s outcomes over individual goals to achieve our company mission – together.
The Senior Manager of Facilities is a Subject Matter Expert (SME) with demonstrated advanced knowledge and understanding of Plant Engineering, HVAC, Utilities and Building Automation design practices within the biopharmaceutical GMP environment.
This role is a key position at ArsenalBio and the successful candidate will significantly improve our ability to implement and continuously improve the facilities, maintenance, and calibration strategies for Arsenal’s GMP and Clinical manufacturing, warehouse, and offices. This is an exciting and dynamic opportunity for you to contribute to the development of new principles and concepts and to be challenged and lead change in having a facilities and engineering perspective. The individual will report directly to the Head of Facilities & Engineering.
This role provides technical support to the manufacturing facility, including the design and specification of plant utilities, and building management platforms. The Senior Manager will be part of a dynamic group of engineers who are responsible for capital and expense project delivery, equipment and utility troubleshooting, root cause analysis, and providing optimization strategies for process support equipment within multi-product, FDA regulated GMP facilities.
The ideal candidate will lead a team of engineers and mechanics with the mission to sustain GMP production equipment and drive various equipment development projects in support of ongoing cost reduction, quality enhancement, capacity creation, new product introductions, and / or product transfer initiatives. This leader is also responsible to establish and monitor the performance of work order, calibration, and preventive maintenance programs and drive continuous improvement of equipment metrics. Additionally, this leader will also be responsible for managing all F&E Quality records and ensuring on-time completion.
What You Will Do:
- Establish GMP processes for asset management, work orders, calibration, and preventative maintenance
- Ensure the F&E department is in compliance with all Quality processes and initiatives
- Provide leadership and supervision to various facilities department staff, contract staff and contracted equipment service providers supporting the F&E systems and functions
- Manages all F&E Quality records (Deviation, CAPA, Change Control, Risk Assessments, and Audit Reports) and ensures on-time closure through thorough well written documentation
- Serve as SME on Facility Engineering Design and Construction for laboratory and GMP manufacturing expansion projects within Facilities & Engineering, sharing best practices, technical know-how and adding significant value to the group
- Provide technical expertise to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities
- Provide technical leadership to monitor physical plant health through system reliability analyses
- Participate in gap analyses and risk assessments to support process tech transfers
- Review and provide recommendations on design drawings, which may include PFDs that incorporate mass or energy balances and P&IDs, which include all line sizing, instrumentation and control philosophies
- Interact with vendors concerning contracts of critical financial value and select vendors based on key performance criteria
- Participate as technical expert in site regulatory inspections, as needed
What Will You Bring:
- BS/MS in engineering discipline preferred
- 8+ years of applicable Facilities and Engineering experience and 3+ years of supervisory experience
- Advanced knowledge of Biologics Process Engineering Design and Construction
- Excellent communication skills, both written and verbal
- PE licensure is preferred
- Experience in the selection and design of leading industrial control systems including Siemens Desigo, Rockwell, Allen Bradley, and Siemens Simatic / WinCC
- Prior experience in biological/viral commercial GMP facility
- Validation experience related to equipment, utility and process systems, including requirements for documentation and testing
- Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation
What We Will Offer You:
An opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM to advance therapies to patients who need it most.
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of the San Francisco Bay area ranges from $155,100-$190,000.
Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.
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