Manufacturing Team Leader

3 weeks ago

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

Country: United States

Position Overview

At Werfenlife SA, our Supervisors play a crucial role in managing the daily operations of their designated teams. This role entails planning, organizing, and allocating work tasks for the production of our high-quality products, while adhering to productivity benchmarks, quality standards, and departmental goals. The Supervisor is also responsible for addressing operational challenges and proposing enhancements to workflows, processes, and the overall work environment. Close collaboration with team members and other departments is essential to achieve our objectives and deliver superior products and services. It is imperative that all team members comply with Werfenlife SA policies and administrative guidelines. All activities must align with established Standard Operating Procedures (SOPs), Quality Systems Regulations (QSRs), and safety protocols.

Key Responsibilities

Primary Duties:

  • Oversees daily production activities conducted by the team, ensuring compliance with SOPs and quality system 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 and evaluation processes.
    • Investigation and resolution of production-related issues.
    • Setup, calibration, validation, operation, cleaning, and maintenance of laboratory equipment.
    • Creation, approval, and implementation of Engineering Change Orders (ECOs) for manufacturing documentation and SOPs.
  • Monitors production processes to identify, assess, and implement operational improvements to enhance performance, service quality, and cost efficiency.
  • Collaborates with team members to delegate tasks, provide guidance, and resolve issues to ensure seamless daily operations.
  • Plans and oversees the workflow within the team to guarantee sufficient materials and resources to meet productivity and quality expectations.
  • Trains and communicates with direct reports to clarify expectations and ensure adherence to Quality Systems and administrative policies.
  • Ensures completion of all necessary documentation in accordance with QSRs.
  • Investigates and analyzes production challenges, executing corrective actions to optimize product performance under the guidance of department management.
  • Drafts and revises SOPs and manages Engineering Change Orders (ECOs) for departmental documents.
  • Engages with other departments and personnel to facilitate efficient operations.
  • Assists in staffing decisions to cultivate a high-performing team, including interviewing, selecting, training, and developing personnel.
  • Oversees departmental schedules to ensure achievement of goals, including approving schedules, time off, and timekeeping records.
  • Conducts performance management and development activities, including setting expectations and providing constructive feedback. Offers development opportunities where feasible and proactively manages employee relations issues.
  • Maintains open and transparent communication within the department through regular one-on-one meetings, team discussions, and other communication methods.
  • Responsible for training staff to ensure competency and compliance with training requirements.
  • Educates and supervises staff to ensure adherence to applicable Werfenlife SA SOPs, ISO, FDA, and other Quality System Regulations, as well as Environmental, Health & Safety, Human Resources, and other regulatory policies.
  • Embodies the company values and serves as a role model for staff and stakeholders.

Budget Oversight

  • Indirectly supports departmental budget management by effectively controlling expenses.
Internal Relationships
  • Planning Team
  • Quality Control
  • Technical Support
  • Research & Development
  • Biochemistry Team
  • Quality Assurance
  • Purchasing
  • Marketing
Competencies
  • Werfen People Manager Competencies: Talent development, Customer orientation, Decision-making, Innovation, Results-driven, Emotional intelligence.
  • Werfen Values: Integrity, Leadership, and Results Delivery.
  • Establishes productive relationships within their sphere of influence.
  • Coaches team members for immediate and future success.
  • Demonstrates sound reasoning and problem-solving capabilities.
  • Takes initiative to identify and act on opportunities for improvement.
  • Contributes to the appropriate management of product disposition.
  • Provides informed counsel to management.
Qualifications

Minimum Knowledge & Experience Required:

Education:

  • Bachelor's degree in biology or a related field 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, ideally within life sciences.

Skills & Knowledge:

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

Management retains the discretion to substitute relevant work experience for educational qualifications and/or to make exceptions to the years of experience requirement.

International Mobility
  • No
Work Environment

The physical demands outlined here represent those that must be met by an employee to successfully perform the essential functions of this position. While executing job duties, the employee is regularly required to communicate effectively. Must be capable of detecting, identifying, and inspecting scientific data. The employee will be required to stand and/or walk for up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands for various tasks, including operating laboratory equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel, or crouch. Will be required to talk and hear, with specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Occasionally, the employee may need to lift and/or move up to 25 pounds. The noise level in the work environment may vary but is typically moderate. This position is highly active and requires varying levels of mobility.

Travel Requirements
  • Less than 5% of the time
Salary Range

The salary range for this position is currently $70,000-$110,000. Individual compensation is determined based on experience, skills, knowledge, education, certifications, span of control, complexity of functions reporting into the position, internal equity, budget, and/or business and organizational needs.

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