Industry-leading Biotech company in Maryland is hiring for multiple Lead Manufacturing Associate (MA) positions at their Baltimore Vaccine Manufacturing Facility to support current projects for vaccine development; including COVID-19 programs.

Prior experience in GMP manufacturing and operation of GMP process equipment for either upstream or downstream production are prerequisites.

Our client has created an environment where employees have a sense of ownership about their future and can excel in an environment characterized by respect, innovation, and growth opportunities. This is an opportunity to join passionate professionals who advance their scientific, technical, and professional skills to develop products designed-to protect life.

JOB SUMMARY

The Lead Manufacturing Associate position reports to the Sr. Manager Manufacturing at the Baltimore Manufacturing Facility. Prior experience in GMP biologics manufacturing and operation of bio-process GMP process equipment are prerequisites.

ESSENTIAL FUNCTIONS

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

• Operates bio-pharmaceutical manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
• Demonstrates, understands and adheres to company policies, GMP standards and safety procedures
• Informs Manager on progress of projects, transfer of data, process details, etc.
• Executes batch records according to GMP and site quality standards
• Generates Batch Records, SOPs and Protocols as required
• Responds to off-hour alarms as assigned by the Manager Manufacturing
• Executes manufacturing cleanroom changeover
• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
• Supports QA during audits and regulatory inspections
• Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

MINIMUM EDUCATION, EXPERIENCE, SKILLS

High School diploma required, BS in biological sciences/biotechnology or related field preferred

• Minimum 2 year of GMP pharmaceutical experience
• Hands-on experience with the installation, operation, cleaning and maintenance of pharmaceutical GMP equipment
• Computer literate (Word, Excel and PowerPoint)
• Previous SAP experience preferred