Senior Manager, Reagent Production (Swing Shift, Monday - Friday)

1 Month ago • 2-3 Years • Product Management

Job Summary

Job Description

The Sr Manager, Reagent Production (Swing Shift, Monday - Friday) is responsible for overseeing production across multiple shifts and locations within a designated manufacturing division. This role supports leadership across shifts and locations, requiring availability outside standard work hours. Key responsibilities include managing staffing and equipment scheduling, approving transfers, and ensuring standardized training. When supervisors are unavailable, the manager directly manages the production team, handling corrective actions, hiring, timesheet approval, and assisting technical leads with workflow and troubleshooting. The role also involves coordinating and resolving non-standard events, reviewing non-conforming production events, and overseeing rework procedures. Additionally, the manager ensures timely product delivery by executing production schedules, resolving process/product issues, and collaborating with engineering and QA on quality investigations. They oversee in-process testing, manage R&D orders, and ensure production processes are standardized and monitored for performance. The manager may lead division projects, implement process improvements, and serve as a technical expert for initiatives like automation and workflow design. The role requires adherence to company policy and the Quality System.
Must have:
  • Minimum 2 years in a regulated manufacturing environment.
  • Minimum 3 years in a leadership role.
  • Bachelor’s degree/4 year program with an emphasis on biological science or 5 years in a biological science or related field.
  • Well-developed interpersonal communication and team leadership skills.
  • Ability to organize, lead and evaluate work of others.
  • Ability to address and resolve employee performance and behavioral issues.
  • High level of organization and attention to detail.
  • General computer literacy (spreadsheet, word processing).
  • Basic math skills.
  • Ability to write reports, manufacturing procedures, and training material.
  • Ability to define problems, collect data, establish facts, and draw conclusions.
  • Ability to communicate clearly in written and oral formats.
  • Ability to ascend/descend stairs, ladders, ramps.
  • Ability to wear PPE correctly most of the day.
  • Ability to adjust or move objects up to 50 pounds.
Good to have:
  • Supervisory experience with direct reports is preferred.
  • Experience in industry and knowledge of FDA and ISO 9001 and 13485 preferred.
  • Experience with Temporary Deviations, rework procedures, NCR’s.
  • Experience with problem identification, corrective actions, data review and analysis.
  • Experience overseeing in-process testing.
  • Experience communicating and clarifying special instructions.
  • Experience implementing improvements to manufacturing processes.
  • Experience with automation, workflow design, and 6S.
  • May serve as a member of the BERT team and/or safety committee.

Job Details

Description

  1. Perform all work in compliance with company policy and within the guidelines of Biomerieux's Quality System. 
People:
  1. Supports leadership team across multiple shifts and/or locations, and is expected to be available outside standard work hours. 
  2. Supports supervisors with complex Human Resource issues such as company-paid leave, accommodations, and terminations. 
  3. Execute staffing and equipment scheduling plans across multiple shifts and/or locations. 
  4. Approves and coordinates transfers across shifts and locations within the manufacturing division. 
    1. Ensure training and proficiency is standardized across shifts and/or locations. 
    Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:     
    1. Provide direct management of the production team assigned to the shift. Responsible for basic corrective action such as attendance, behavior, and performance and consults with the manager for more complex human resource issues such as company-approved leave and accommodations. 
    2. Responsible for interviewing and hiring personnel for the assigned shift. 
    3. Responsible for timesheet approval, PTO approvals, timesheet approval and attendance tracking. 
    4. Responsible for assisting Technical leads & Team leads with technical issues such as training, organization workflow, and troubleshooting production issues. Works with team to adapt to changes affecting daily production schedule to ensure available team resources can meet planned production 
    Product:
    1. Coordinates and resolves non-standard events such as scheduling issues, downtime, or non-conformance events that span multiple shifts or locations. 
    2. Reviews and approves disposition of non-conforming production events. Works with the area Director or Associate Director on non-standard, more complex NCRs. 
    3. Writes and oversees rework procedures in accordance with the Quality Management System. 
Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:     
  1. Provide on time delivery of products by executing production schedule, and by resolving process/product related issues using tools such as Temporary Deviations, rework procedures, NCR’s, etc. 
  2. Responsible for working with engineering and QA on quality investigations including problem identification, corrective actions, data review and analysis and timely completion of documentation. 
  3. Responsible for overseeing all in-process testing in the pouch and array areas and ensuring the control plan is being followed as documented. 
  4. Ensure that R&D orders are completed correctly by communicating and clarifying special instructions to the team as necessary.  
Processes:
  1. Ensures production process is standardized across multiple shifts and/or locations. 
  2. Monitors performance across multiple shifts and/or locations and works with area leadership to resolve issues. 
  3. May serve as the manufacturing lead in projects and initiatives assigned to the division. 
  4. Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:     
  5. Work closely with Operations management to identify and implement improvements to manufacturing processes. 
  6. Serves as technical expert and contributes to decisions regarding developmental and process improvement initiatives such as automation, workflow design, and 6S. 
  7. May serve as a member of the BERT team and/or safety committee. 
  8. Perform additional duties as assigned by management 

Supplemental Data:

Is responsible for production completed across multiple shifts and/or locations within a designated manufacturing division. Leadership across multiple shifts and/or sites and reports into the Associate Director or Director of Manufacturing.
 
Training and Education:
Bachelor’s degree/4 year program with an emphasis on biological science.
In lieu of bachelor's degree, 5 years in a biological science or related field
 
Experience:
  1. Minimum of 2 years in a regulated manufacturing environment with a minimum of 3 years in a leadership role. Supervisory experience with direct reports is preferred
  2. Experience in industry and knowledge of FDA and ISO 9001 and 13485 preferred

Knowledge, Skills, Abilities:

  1. Knowledge, special skills, and/or abilities required to perform the job functions (e.g., negotiation, technical writing, Well-developed interpersonal communication and team leadership skills. Must be able to communicate and collaborate with direct reports as well as cross-functional colleagues.
  2. Ability to organize, lead and evaluate the work of other personnel.
  3. Ability to address and resolve employee performance and behavioral issues in a professional manner.
  4. Exhibit a high level of organization and tremendous attention to detail.
  5. General computer literacy spreadsheet word processing software.
  6. Basic math skills. 
  7. Ability to write reports, manufacturing procedures, and training material.
  8. Ability to define problems, collect data, establish facts, and draw valid conclusions.
  9. Ability to communicate clearly in both written and oral formats.
Working Conditions:
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
Ability to adjust or move objects up to 50 pounds in all directions.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).

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