Team Lead, Manufacturing

Compensation

: $104,250.00 - $156,850.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary

The primary role of this position is to provide technical support for all fill finish operations with strict adherence to cGMP compliance. The candidate will be leading all aseptic fill operations, visual inspection, labeling, and packaging of bulk product with minimal supervision. This position requires proficiency in aseptic technique, and extensive knowledge working with various isolators. The candidate will be working closely with all cross-functional departments. This position will be reporting to the Manufacturing Manager at the Emergent Rockville Site.

II: Responsibilites
  1. Extensive hands-on knowledge of Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
  2. Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and company policies.
  3. Execute daily tasks such as washing/sterilizing vials and filling components for use in production operations. Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/post production.
  4. Foster team building and provide the necessary training to other staff members as required.
  5. Author and revise batch records and SOPs.
  6. Perform routine reviews on executed batch records and logbooks.
  7. Initiate deviations, CAPAs, and Change Controls. Lead implementation of corrective actions and changes as directed by site management.
  8. Support Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment.
  9. Generates Purchase requisitions and service receipts for consumables items within the MFG department.
  10. Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
  11. Lead all on-floor daily activities as per the production schedule.
  12. Occasional overtime and weekend work is required.
  13. Perform tasks under minimal supervision, and within tight time lines to meet production schedule.
  14. Inform manager on progress of projects, transfer of data, process details, etc.
  15. Communicate and suggest regular process improvement to management. Provide and receive open communication to cross functional team members on a routine basis.
  16. Report any unexpected observations and suggest possible explanation and resolution.


The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

BS/BA in Biology, Chemistry, or related discipline and 5-8 years experience in a GMP facility or High School Diploma and at least 10 years experience in a GMP facility. Task and team-oriented, analytical, organized, detail-oriented, self-motivated, and good at multi-tasking. Previous experience working with isolator technology is required.

IV: Physical/Mental Requirements

Must be able to follow cGMP regulations during operations including adherence to written procedure and contemporaneous documentation. Must be able to communicate effectively with Management and staff. Must be able to record data accurately and legibly, have good manual dexterity, ability to lift 50lbs, demonstrate mechanical aptitude and the ability to perform in a team setting in a controlled environment for long periods of time.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Associated topics: forklift, inventory, manage, management, mow, plant management, prune, ship, transplant, watering * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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