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Operations Manager

2 months ago

Scottsdale, United States CND Life Sciences Full time
Job DescriptionJob Description

The Operations Manager (OM) is responsible for overseeing specimen collection supply inventory, assembly of supplies, and fulfilment of orders for commercial and research testing performed by CND Life Sciences. The OM performs specimen collection supply assembly, inventory and production quality control operations in accordance with regulatory guidelines in a rapidly growing department. The OM will foster a culture of continuous improvement and ensure timely production, shipping and response to customer, study sites, and sales team requests.

The Operations Manager will implement work instructions, procedures, manufacturing and assembly processes and workflows for growing and evolving needs in meeting the collection supply orders and needs, including assembly production and logistics capabilities. The OM uses supply chain and procurement knowledge to identify and maintain appropriate supply for specimen collection needs. The OM uses CND's software application environments to oversee approval, release, and shipping of sample collection packages in accordance with standard protocols and applicable guidelines (GMP, ISO, CAP, CLIA) including participation in audit preparation activities for applicable sponsors and agencies. The Operations Manager will administer and maintain department trainings for personnel. The OM is expected to collaborate and work proactively with key stakeholders including Quality, R&D, and Clinical Services, be self-motivated, and identify and implement improvements within the assembly and logistics space. The OM will identify and document areas of improvement that are needed to meet production goals and serve customers.

This position works under the direction of the Chief Operating Officer (COO) of CND Life Sciences, with ongoing guidance from Quality and Research and Development. In all cases, the Operations Manager follows standard laboratory procedures and policies. The OM will oversee Material Handlers and Procurement Specialist and provide mentorship and direction and inform needs for departmental growth. The OM will establish daily and weekly objectives for the team to ensure CND has sufficient back stock and specimen collection supply supplies on hand. The OM will work closely with Quality to maintain appropriate documentation and stay in compliance with all applicable regulatory requirements.

Job Responsibilities:

Test Collection Supply Activities

  • Working at CND's headquarters, serve as Manager and operator for assembly production and shipping of Syn-One and other CND sample collection and marketing supplies to sales teams and customers; ensure all contents are included with appropriate quality control checks.
  • Directly supervise materials and logistics personnel performing assembly, production and execute specimen collection supply shipments to physician practice, study site, and sales team customers.
  • Keep track of supply storage in keeping with applicable requirements, including but not limited to GMP and ISO.
  • Keep close track of specimen collection supply and demand by using CND's CRM and other software
  • Collaborate closely with Clinical Services to ensure customer needs are met and specimen collection supply inventories are managed effectively
  • Collaborate closely with the R&D team to ensure clinical study needs for specimen collection supplies are met
  • Collaborate closely with the Sales team to ensure sales staff has adequate and controlled "trunk stocks" of specimen collection supplies to be provided to customers
  • Perform routine internal departmental audits for compliance and performance of the department and verification that all specimen collection supplies are shipped in a timely manner.
  • Ensure department is producing a quality assembled product with appropriate documentation in an efficient and timely manner.
  • Follow applicable Procedure, Environmental, Quality, and Safety documents, notify Manager immediately if not correct.
  • Executes continuous improvement projects as assigned by management using lean principles and concepts.
  • Evaluates the performance of team production personnel.
  • Instruct and conduct employee trainings, including appropriate documentation of attendance.
  • Work on assembly and shipping functions alongside the team to ensure that departmental objectives are accomplished.
  • Analyze data from shipping and delivering processes to meet operational performance standards.
  • Adhere to all regulations (US and international) with regard to shipping and applicable procedure pack assembly guidelines.
  • Provide monthly inventory updates to leadership and alert the team when there are issues with supply procurement or critically low inventory

General Inventory & Supply Activities

  • Interface with CND suppliers regarding orders, supplies and requirements related to specimen collection supply assembly operations.
  • Ensure sufficient supply customer specimen collection supply inventory and other materials
  • Maintain accurate supply order history
  • Work with management to help negotiate best price, term, conditions, and settlements (as applicable)
  • Complete cost analyses and recommend improvements and alternatives
  • Perform all duties and responsibilities in accordance with established purchasing and accounting policies
  • Lead Sales, Inventory, Operations Planning (SIOP) process
  • Communicate both internally and with suppliers regarding inventory or specimen collection supply matters
  • Assist in the training and oversight of the logistics assistant
  • Other duties and responsibilities as assigned.
  • Oversee the daily activities of the logistics assistant and provide guidance and direction

Knowledge, Skills & Experience:

  • Minimum of 4-6 years-experience in a Manager capacity in production, inventory management, or related position required.
  • Experience in developing and leading SIOP Processes
  • Experience in GMP, ISO and quality control processes
  • Must be able to foster a high-production and customer-focused culture and lead the team by example.
  • Must be a self-starter and be able to successfully execute initiatives with minimal guidance and accomplish stated goals.
  • Able to take direction and strike a balance between operations and leadership.
  • Proven success leading and motivating employees through consistent, effective and fair methods.
  • Must always lead by example and be a role model to the leads and operators on the floor while treating people with respect, dignity and professionalism.
  • Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint).
  • Self-motivated with competent interpersonal skills
  • Knowledge of negotiation, materials resource planning, inventory management techniques, cost analysis and production processes
  • Excellent verbal and written communication skills
  • Commitment to collaboration and support of team members
  • Prior experience managing operational and continuous improvement projects.
  • Strong attention to detail
  • Customer-focused
  • Flexibility and adaptability
  • Multitasking capabilities

Education, Certifications & Licensures:

  • Bachelor's Degree or equivalent experience in supply chain, business administration, systems engineering, or other related field required.
  • Lean Certification or Six Sigma training preferred
  • APICS Certification preferred

Physical Demands:

  • Combination of seated and standing work to complete the core functions of the role
  • Sit and stand for long periods of time
  • Visual acuity and analytical skills
  • Must perform repetitive motions
  • Ability to lift up to 50 pounds
  • May have exposure to fumes and bio-hazardous materials in the laboratory environment
  • Handling of general laboratory reagents