Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10000 per calendar year
Onsite cafeteria with daily food stipend
Shift differential pay for nights and weekends.
Position Summary:
Normal working hours are Sunday -Thursday from 10:00 PM - 06:30 AM.
The primary purpose of this position is to assist in managing the manufacturing activities for the production of Vitek susceptibility and identification media in accordance with cGMP, FDA, ISO and other regulations/policies. This position will provide expert guidance from a manufacturing level on all departmental technical and material topics in order to ensure the achievement of high quality product. Additional functions for the Team Lead include but are not limited to providing training, attending intra- and inter-departmental meetings, creation of production schedules and daily reports, managing manufacturing and inventory databases, as well as undertaking other projects as needed.
Primary Responsibilities:
- Perform all work in the Production Department in a safe manner in accordance with the company policy and/or procedure. Maintain Safety Data Sheet (SDS) access and encourage safety programs.
- Train new and coach existing team members to develop strong technical and leadership skills throughout the department. Track progress of on-the-job training of new employees. Report personnel issues or deficiencies to Management as needed.
- Provide expert knowledge of departmental procedures and consistently uphold all company policies. Ensure that all procedures reflect the current methods used by the team. Develop and write new procedures as needed. Assist in coordination of training on technical updates and procedural revisions.
- Assists Management in APT Meetings, technician scheduling, and shift reporting. Ensure that product is completed and delivered to Card Production in accordance to the production schedule. Maintain contact with Card Production management to communicate production updates as needed. Will alter normal breaks and lunches to meet production schedule with support from Management as needed.
- Schedule and edit product for manufacture in MES, AMDS and SAP as needed in response to daily production demands. Maintain and update manufacturing and inventory databases on a regular basis.
- Provide expert guidance with end of lot documentation review, delivery and corrections for Device History Record - Master Formulary, etc. All documentation practices are to follow all appropriate procedures/policies.
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Support the standard of cleanliness set forth in department 5S guidelines by administering frequent internal audits. The audits include, but are not limited to, checking for:
- Clean and organized lab workspaces,
- Clean instrumentation and equipment,
- Workstations maintained according to 5s principles,
- Any unspecified actions are undertaken that are required to maintain 5s compliance.
- Maintain adequate inventories of general lab supplies and chemical materials. Initiate requests for additional equipment as needed. Maintain FEFO for all long-term stocks, broths and chemical components.
- Troubleshoot instrument and/or equipment repair immediately to prevent production delays and get Line Maintenance or Facilities involved when appropriate. Identify areas of deficiency and implement best practices to improve employee safety and reduce cost incurred by poor process design.
- Participate in new product development and assist with new product transition to production from R&D and Industrialization as required.
- Perform other duties and projects related to lab and department operations as requested by Management.
Education, Skills, & Experience:
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Bachelor of Science degree in Biology/Chemistry with two (2) years wet chemistry and/or bench work experience preferred OR
- Associates Degree with 4+ years wet chemistry and/or bench work OR
- High School Diploma/GED and 6+ years of wet chemistry and or bench work experience is required.
- A minimum of two (2) years supervisory experience preferred.
- Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands using advanced problem solving, time management and laboratory skills.
- Strong leadership with the ability to motivate other team members and manage multiple schedules.
- Ability to work independently and in groups with diverse backgrounds and levels of experience.
- Ability to effectively train and coach other team members to enhance the technical and behavioral culture.
- Advanced knowledge of GLP/GMP and ISO guidelines, sterile techniques and general laboratory procedures. Ability to quickly learn new procedures and reduce to practice.
- Strong PC skills (MS Office – Excel, Word, PowerPoint, Outlook; MES and SAP desired).
- Must be able to work both independently with minimal guidance or oversight as well as in tandem with all levels of corporate personnel. Show understanding, tact, and patience when working with diverse team members to maintain positive working relationships throughout the company.
- Make sound, well-informed judgments with the quality of product at the top of their mind when forming decisions. Lead by example and reinforcing corporate values that lead to the success of the department.
- Adapts well to a frequent changes to expectations, priorities, and production demands; must be accepting of changing methods to align with new information, changing conditions and unexpected obstacles.
- Recognizes when to seek clarity, communicate issues to Management, and ask for assistance in attaining a goal; ability to both prioritize and delegate assignments to achieve efficiency and success.
- Encourage the development of others through guidance and mentorship; fosters an environment of teamwork and flexibility amongst the department.
- Conveys goals and objectives clearly and in a compelling manner; listens effectively and clarifies information as needed; produces clear status reports; communicates tactfully and candidly.
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