Team Leader, Manufacturing Operations (Packaging)

Thermo Fisher Scientific • Fremont, CA

2d • Onsite

About The Position

The Team Leader, Manufacturing Operations supervises approximately 10 Packaging Operators, including a Lead Operator, at the Fremont, California site within the Niche Diagnostics Division. Reporting to the Manager, Manufacturing Operations, this is a direct people-supervisory and hands-on working leadership role. The Team Leader handles day-to-day team leadership, including work assignments, coaching, attendance, timecards, PTO, performance reviews, and corrective actions, and is accountable for the team's safety, quality, delivery, and productivity performance.

Alongside supervising the team, the Team Leader regularly performs packaging operations and provides production coverage. The role may also support Filling, Packaging, and Label Printing teams based on business needs or manager assignment. The schedule is primarily first shift, approximately 6:00 AM to 2:45 PM, with flexibility for schedule changes and overtime based on production needs.

The position is in a cGMP-regulated diagnostic kit manufacturing environment and requires working as an authorized handler of DEA-controlled substances (Schedules I–V). The work environment includes a laboratory setting, loud equipment and machinery, required GMP and safety practices, and PPE. Physical demands include standing and walking for extended periods, lifting up to 40 pounds without assistance, and working in cold environments.

Requirements

• High school diploma or GED.
• At least 2 years of experience supervising direct reports, including assigning work, approving timecards, completing performance reviews, and addressing performance or attendance issues; lead experience without direct reports does not meet this requirement.
• At least 5 years of manufacturing experience in a regulated environment such as FDA, cGMP, or ISO 13485.
• Hands-on experience with nonconformances, deviations, or CAPAs, such as initiating nonconformances, supporting root cause investigations, or completing corrective actions.
• Flexibility to work overtime and accommodate schedule changes based on production needs.
• Willingness to support other Manufacturing Services teams as needed or as assigned by the manager.
• Working knowledge of cGMP, GDP, FDA quality system requirements (21 CFR Part 820), and ISO 13485.
• Ability to coach and develop employees, provide direct feedback, and handle difficult conversations fairly and consistently.
• Strong communication skills with operators, peers, and cross-functional support teams.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to stand and walk for extended periods, lift up to 40 pounds without assistance, work in cold environments, and wear required PPE.
• Ability to successfully complete applicable background screening, including screening related to controlled substances.

Nice To Haves

• Associate's or bachelor's degree.
• Experience in packaging, kitting, or labeling operations in diagnostics, pharmaceutical, medical device, or another cGMP-regulated industry.
• Experience with QAD, Agile, Workday, or similar ERP, document control, and HR systems.
• Lean Six Sigma certification (Yellow Belt or higher) or experience with Lean, 5S, and structured problem-solving tools.
• Experience handling DEA-controlled substances.

Responsibilities

• Supervise direct reports, hold regular one-on-one meetings, provide timely feedback, complete performance reviews, and address performance, attendance, or conduct issues with HR support.
• Lead daily Tier 1 meetings to review safety, quality, delivery, and productivity metrics and set daily priorities.
• Approve timecards and PTO requests, monitor attendance, and coordinate staffing coverage to maintain production schedules.
• Train and cross-train operators, maintain accurate training records, and keep the skills matrix updated.
• Assign daily work across packaging lines, label application, and kitting operations to meet production schedules.
• Perform packaging, kitting, and labeling operations alongside the team and provide production coverage as needed.
• Verify materials, components, and required documentation are available before scheduled work orders.
• Collaborate with Planning, Engineering, EHS, QA, and QC to resolve equipment, process, and documentation issues.
• Support other Manufacturing Services teams as needed or as assigned by the manager.
• Ensure manufacturing activities comply with cGMP, SOPs, GDP, and applicable safety requirements.
• Review batch records and logbooks for completeness and GDP compliance before submitting them to QA/QC, and follow up on corrections.
• Initiate nonconformances, support deviations and root cause investigations, and complete assigned CAPAs on time.
• Lead or participate in PPI, Lean, and 5S activities to reduce waste, improve efficiency, and minimize errors.
• Perform other duties as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED