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Group Lead, Formulation - 3rd Shift

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Location: Durham, United States
Position Type: Unfixed Term
Job Function: Manufacturing

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Position Summary:

  • The Group Lead position is responsible for
    • Front-line leadership of their teams.
      • All aspects of reagent formulation, production/packaging inspecting, preventive maintenance, cleaning, troubleshooting and/or repair of manufacturing/process equipment of their respective areas
      • May provide indirect leadership for other teams as assigned
    • Following regulatory and customer requirements.
    • Development of internal candidates by providing expanded responsibilities in relation to team leadership, including personnel performance management and accountability for team performance metrics and projects.
    • Ability to effectively lead quality initiatives is critical to the department’s ability to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency.
    • Reduction of manufacturing costs/scrap

 

Primary Duties:

Management

  • Coordinate department requests for equipment or personnel support  that impact Manufacturing operations.
    • This may include but is not limited to Engineering, QC, R&D, Validation or Maintenance.
  • Oversee and assist Technicians in management of daily activities including  scheduling cleaning activities
  • Maintain an efficient and effective workforce.
  • Contribute to team goal development, status tracking and communication through the PMP (Performance Management Program) process Communicate with other departments (i.e. Materials Management, Production Operations, and Quality Control as needed to ensure the timely and efficient production of all of our customer requirements.
  • Conduct meetings (team and/or safety) as needed, keep records/documentation of information discussed.
  • Perform other duties as assigned by Management.

Leadership / Employee Development

  • Provide performance feedback coaching and development for Team Leads and/or team members. 
  • Complete formal performance evaluations for all direct reports.
  • Inspire and motivate production teams to achieve top performance.
    • Promote self-growth and internal development within the team
  • Demonstrate and work towards developing the following attributes:
    • Inspire, motivate, and guide others toward goal accomplishments. Consistently develop and sustain cooperative working relationships. Encourage and facilitate cooperation within the organization and with customer groups; foster commitment, team spirit, pride, and trust. Develop leadership in others through coaching, mentoring and guiding.
    • Convey goals and objectives clearly and in a compelling manner; listen effectively and clarify information as needed; interpret verbal and non-verbal messages that others communicate; produce clear status reports; communicates tactfully and candidly.
    • Lead by example.

Documentation & Training Compliance

  • Utilize a variety of software systems to support daily work activities (i.e. TrackWise, LiveLink/DocLink, SAP, BRAM, Compliance Wire, etc.).
  • Ensure overall team training compliance is maintained current for processes and procedures relevant to all activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
  • Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.
  • Provide assistance with the creation, review and revision of instructions and SOPs necessary for the Manufacture of BacT/ALERT products.

Continuous Improvement

  • Lead and promote continuous improvement through team and individual initiatives.
  • Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others
  • Lead project teams and/or serve as a project team member to reduce scrap, improve product quality, decrease operational costs, and increase departmental efficiency/productivity.
  • Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices.

Quality / Manufacturing Compliance

  • Coordinate with the shift Manufacturing Compliance team member(s) to mitigate errors via the Right The First Time (RTF) initiatives
  • Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
  • Maintaining the BacT/ALERT manufacturing operation so that it is GMP compliant and meets all regulatory requirements.
  • Review documentation to support manufacturing, maintenance history records and training requirements that adhere to all applicable procedures and regulations.
  • Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability. 
  • Assist with and/or lead Manufacturing investigations, CAPA actions, In-Process Events (IPEs) and other process equipment related quality concerns.
  • Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all other applicable policies and regulations.

 

Knowledge, Experience and Skills:

  • High School Diploma or GED
  • A minimum of 5 years in a GMP production/operations environment

Skills:

  • For Manufacturing and Packaging Group Leads
    • Demonstrated proficiency in the operation of high speed, highly automated, production equipment is desired.
    • Mechanical background desired.
    • Four or more years of experience maintaining and repairing manufacturing equipment desired. 
  • For Formulation Group Leads
    • Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired. 
    • Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment desired. 
  • Prior BacT/ALERT  Leadership Experience in a regulated environment preferred
    • Knowledge of FDA regulations desired
    • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) is desired.
    • Clean-room experience desired.
  • Experience is scheduling activities cross functionally in a high pace manufacturing environment preferred.
  • Flexibility around changing priorities
  • Demonstrated experience of working independently is desired. 

 

Impact/Management Scope:

  • Scope and Resources Accountability:  The Group Lead will supervise and be accountable for the production activities of cross-functional groups comprised of 2 –15 staff members.
  • Financial Indicators (revenue, budget, etc.): Financial Indicators include but are not limited to: Budget Adherence, Finished Good Bottle Cost, Customer Service Rate, Scrap Rate
  • Key Performance Indicators (KPIs): KPIs include but are not limited to: Schedule Adherence, Quality/Compliance (Human Error Rate), Training Metrics, Scrap Rate, Labor hours
  • Key Contacts (internal / external) and Interfaces: Key Internal Contacts include but are not limited to: Quality Assurance, Quality Control, Industrialization & Engineering, Maintenance & Reliability, Calibration, Human Resources, Operations Training.

 

Other:

  • Ability to regularly climb stairs to perform work
  • Ability to work overtime as required to support a 24/7 production operation
  • May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials
  • May be exposed to strong odors incurred during media production or other operations
  • May be required to wear various types of PPE  which includes but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. 

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

 

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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