Bioprocess Team Lead - 3rd Shift

 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

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.

This position is 3rd Shift, 10PM - 6:30AM

 

ESSENTIAL FUNCTIONS 
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

• Extensive hands-on knowledge of Aseptic filling operations and dynamic monitoring/sampling inside various isolators. 
• Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and company policies. 
• 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. 
• Foster team building and provide the necessary training to other staff members as required. 
• Author and revise batch records and SOPs. 
• Perform routine reviews on executed batch records and logbooks. 
• Initiate deviations, CAPAs, and Change Controls. Lead implementation of corrective actions and changes as directed by site management. • Support Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment. 
• Generates Purchase requisitions and service receipts for consumables items within the MFG department. • Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries. 
• Lead all on-floor daily activities as per the production schedule. • Perform tasks under minimal supervision, and within tight time lines to meet production schedule. • Inform manager on progress of projects, transfer of data, process details, etc. 
• Communicate and suggest regular process improvement to management. Provide and receive open communication to cross functional team members on a routine basis. 
• Report any unexpected observations and suggest possible explanation and resolution.
Requires vaccination against different viruses including Vaccinia virus.

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS 
• BS/BA in Biology, Chemistry, or related discipline 
• 4-6 years’ experience in a GMP facility or High School Diploma and at least 6 years’ experience in a GMP facility. 
• Good interpersonal skills and attention to detail. 
• Analytical, organized, self-motivated, and good at multi-tasking. 
• Previous experience working with aseptic technique and good documentation practices is required. 
• 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. 
• Demonstrated mechanical aptitude and have manual dexterity. 
• Ability to perform in a team setting in a controlled environment for long periods of time
 

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is