Associate Director, Materials Management (2216-N-685-SC)
Company: ArsenalBio
Location: Hayward
Posted on: June 19, 2022
Job Description:
ArsenalBio's mission is to develop efficacious and safe cellular
therapies for patients with chronic diseases, initially cancer. Our
products are being designed to herald the transition of adoptive
cell therapy from a hospital based treatment to outpatient therapy,
like most other cancer treatments. Our people 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.Arsenal Bio is looking for an Associate
Director of Materials Management who is analytical, driven,
strategic, and creative. Reporting into the Supply Chain
Organization the Associate Director will be responsible for the
start-up operations of the Materials Management Warehouse &
Distribution operations. In this critical role, you will be part of
a cross-functional team working on supporting production start-up
activities such as the design, installation, testing, and
validation of manufacturing equipment, processes, and the quality
approach for this exciting technology. The Associate Director will
have extensive knowledge in inventory management & reduction
strategies, lean methodologies, cold chain management, GLP, ERP
systems, and managing clinical and commercial projects for early
stage and late phase drug product development, including
IND/BLA/MAA submission and support of product launch.In addition,
the incumbent will provide leadership and process expertise to
staff members. Work with department and site leadership to develop
and sustain a safe working environment, high performance and
engaged team. The individual should possess a track record of
successful relationship management, great communication skills,
strong business and analytical acumen. This is a pivotal and highly
visible role that engages with local operations, functions and
extended leadership teams on a regular basis.What You Will Do:
- Create an environment of strong team spirit, timely and
effective communications, a sense of urgency, high motivation, and
inspire teams to achieve goals in the immediate and
longer-term
- Be an active and visible change agent, promoting flexible and
open mindsets to new opportunities
- Establish strategic goals and objectives and maintain full
strategic responsibility for the Materials Management
organization
- Drive collaboration within site and across network activities,
cross-functional planning, and decision making
- Accountable for the overall budget and financial performance of
the Materials Management organization
- Manage/support Warehouse & Logistics of raw materials in
support of manufacturing operations
- Manage inventory management system conforming to standard
warehouse practice (Bar Code, FEFO, reorder triggers)
- Manage and implement business continuity plans to support
clinical and commercial operations
- Develop and manage pick and pack system for supply kits to
manufacturing groups utilizing a Bill of Material
- Manage receiving system for both products and materials
- Manage packaging and shipment of the final product
- Implementation, process mapping and creation of materials
management modules, and user acceptance testing (UAT) for ERP
systems as it relates to receipt, inspection, disposition,
inventory, kitting, and shipping of GMP materials
- Lead strategic planning of materials management projects,
including implementation of a new enterprise resource planning
system (e.g., EBS Oracle, SAP, Microsoft Dynamics).
- Monitor commercial/clinical inventory report for quantity, lot
status, expiration dates
- Rebalances inventories based on lot expiration and QA
requirements, as needed
- Develop and implement protocols and practices to ensure
effectiveness and efficiency of strategic initiatives an
inventory/warehouse management
- Drive continuous improvement of the supply's movement,
warehouse level optimization, kitting and kanban processes
- Experience leading and preparing department for PAI
- Knowledge of material resource planning and scheduling
- Develop inventory strategies that minimize financial impact and
develop systems to manage materials across multiple clinical
studies
- Knowledge of cold chain validation program to support USA and
EU clinical and commercial programs
- Proactively promote positive Safety Culture and cGMP operating
principles
- Provide managerial guidance and leadership to frontline leaders
for non-routine issues
- Provide significant guidance for the development of individual
contributors and the building and sustainment of a high-performance
team
- Perform or provide oversight to department and network-related
project activity that may require investigating, analyzing,
formulating solutions, documenting processes, and communicating
results
- Ensure cGMP compliant and lawful execution of all
responsibilities
- Ensure sufficient resources are in place to compliantly and
safely meet site and department objectives
- Additional duties may be assignedWhat You Will Bring:
- Bachelor's Degree or commensurate experience preferred
- Minimum 12+ years of relevant experience in GMP Warehousing and
Distribution operations with 5 years of progressively increasing
leadership accountability
- Experience in Biotech or pharmaceutical or personalized health
care experience or cell and gene therapy manufacturing is
desired
- In-depth working knowledge of inventory management principles,
and cold-chain distribution
- DOT, IATA, International shipping expert
- Demonstrated history of exceptional people development
skills
- Extensive experience and working knowledge of MRP systems
- Expert knowledge in ERP systems
- Strong business acumen - the ability to understand challenges
through the eyes of the regional business leaders
- Strong leadership and collaboration skills
- Influencing skills - the ability to persuade others to change
behavior in pursuit of a common goal
- Strong verbal and written communication skills, with the
ability to confidently present complex information to senior
executives
- Strong project management capabilities
- Demonstrated learning agility, and the ability to improve both
yourself and the people around you
- Creates a positive, diverse, and inspiring work
environment
- Strong critical thinking and problem-solving skills
- Demonstrated continuous learning and development mindset
- Customer centric mindset striving to find the best solution for
the business
- Demonstrated negotiation and influencing skills
- Proven ability to meet tight deadlines, multi-task, and
prioritize workload
- Ability to communicate effectively with both technical and
non-technical team members
- Strong experience in reviewing business requirements and
problem statements
- Highly motivated, self-driven, capable of defining requirements
and developing procurement processesArsenalBio 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.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.
Keywords: ArsenalBio, Hayward , Associate Director, Materials Management (2216-N-685-SC), Executive , Hayward, California
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