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Manufacturing Team Supervisor

2 months ago

San Diego, California, United States Werfenlife SA. Full time

Country: United States

Position Overview

As a Supervisor at Werfenlife SA, you will oversee the daily operations of your designated team. This role involves planning, scheduling, and delegating work assignments for the production of Werfenlife products, ensuring that productivity benchmarks, quality standards, and departmental objectives are met. You will be responsible for addressing operational challenges and suggesting enhancements to processes and the work environment. Daily collaboration with team members and other departments is essential. You will communicate effectively with staff, department leaders, and other Werfenlife personnel to achieve objectives and deliver top-quality products and services. Compliance with company policies and administrative expectations is a must, and all activities will adhere to standard operating procedures (SOPs), Quality Systems Regulations (QSRs), and safety regulations.

Key Responsibilities

Primary Duties:

  • Oversee daily production activities within the team/department, ensuring adherence to SOPs and quality systems requirements, which may include:
    • Preparation of bulk solutions
    • Assessment of raw materials, in-process materials, and final products
    • Development and adherence to master validation plans, ensuring relevant process and equipment validation protocols are established and maintained.
    • Management and review of laboratory documentation related to manufacturing, evaluation, and development tasks.
    • Investigation and resolution of production challenges.
    • Setup, calibration, validation, operation, cleaning, and maintenance of laboratory equipment as necessary.
    • Creation, approval, and implementation of Engineering Change Orders (ECOs) for manufacturing documentation and SOPs.
  • Monitor operations to identify, assess, and implement changes that enhance performance, service, productivity, and cost-effectiveness.
  • Collaborate with team members to assign tasks, address inquiries, make decisions, and resolve issues to ensure seamless daily operations.
  • Plan and oversee the workflow into and through the team/department to guarantee sufficient materials and resources to meet productivity, quality, and service expectations.
  • Train and communicate with direct reports to clarify expectations and ensure compliance with Quality Systems and administrative policies.
  • Ensure all necessary documentation is completed in line with Quality Systems Regulations (QSRs).
  • Investigate, analyze, and implement corrective actions to optimize product performance or resolve manufacturing issues, under the guidance of department management.
  • Draft and update SOPs. Manage Engineering Change Orders (ECOs) for departmental documents, SOPs, Work Instructions, and other Quality Systems documentation.
  • Engage and collaborate with other departments, managers, and staff to ensure efficient operations.
  • Assist in staffing decisions to cultivate a high-performing team, including interviewing, selecting, training, and developing personnel.
  • Manage departmental schedules to meet objectives; responsible for approving schedules, time off, overtime, and timekeeping records.
  • Conduct performance management and development activities, including setting expectations and providing constructive feedback. Facilitate development opportunities where feasible. Proactively manage employee relations issues, consulting with department leadership and Human Resources as needed.
  • Maintain open and transparent communication within the department through effective one-on-one meetings, team meetings, and other formal and informal communication methods.
  • Oversee staff training to ensure competency and compliance with training requirements.
  • Educate and supervise staff to ensure adherence to applicable Werfenlife SOPs, ISO, FDA, and other Quality System Regulations, as well as relevant Environmental, Health & Safety, Human Resources, and all other regulatory and administrative policies.
  • Exemplify company values and serve as a role model for staff and customers.

Budget Management:

  • Indirectly support departmental budget by effectively managing expenses.
Internal Networking/Key Relationships
  • Planning team
  • Quality Control
  • Technical Support
  • Research & Development, including Manufacturing Technical Service (MTS)
  • Biochemistry team
  • Quality Assurance
  • Purchasing
  • Marketing
Competencies
  • Werfen People Manager Competencies: Talent development, Customer focus, Decision-making, Innovation, Results orientation, Emotional intelligence.
  • Werfen Values: Integrity, Leadership, and Results Delivery.
  • Establish productive relationships within your sphere of influence.
  • Coach team members for immediate and future success.
  • Demonstrate sound reasoning and problem-solving abilities.
  • Initiative to recognize and act upon opportunities for improvement.
  • Contribute to the appropriate disposition of products.
  • Provide informed counsel to management.
Qualifications

Minimum Knowledge & Experience Required:

Education:

  • Bachelor's degree in biology or related sciences is required.

Experience:

  • 5+ years of experience in a regulated laboratory environment is required; preferably in immunology or medical device manufacturing.
  • 3+ years of experience in a leadership or supervisory role is required, preferably within life sciences.

Skills & Knowledge:

  • Strong laboratory skills, including solution preparation, assay manufacturing procedures, and laboratory equipment operation. Familiarity with Quality Systems Regulations (QSR) and Engineering Change Orders (ECO) systems as they relate to diagnostics manufacturing.
  • Adept at solving practical problems and managing a variety of concrete variables in situations with limited standardization. Ability to interpret various instructions in written, oral, diagram, or schedule form.
  • Experience with Enterprise Resource Planning (ERP) systems is required, with SAP being strongly preferred.
  • Demonstrated experience with standard administrative and business procedures is required.
  • Proven ability to organize and supervise successful operations and teams is required.
  • Ability to build consensus and relationships among peers, stakeholders, and employees is required.

Management reserves the right to substitute relevant work experience for a degree and/or make exceptions to the years of experience requirement.

International Mobility
  • No
Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify, and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone, and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel, or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.

Travel Requirements