We are seeking a Supervisor, Microbiology Manufacturing in our Lexington, MA office. The successful candidate will be responsible for supervising Microbiology Manufacturing operations from material receipts through shipments including, but not limited to: production scheduling, inventory control, training, formulations, filling, and maintenance of GMP compliance. 

RESPONSIBILITIES WILL BROADLY INCLUDE:

• Supervision and direct execution of microbiology manufacturing processes and personnel that may be assigned to these activities. Including, but not limited to, Glycerol Stock, Cell Bullet, and microbiology reagent products (QCheck and VCheck).
• Authoring of manufacturing documentation such as: work orders, batch records, SOPs, work instructions, and production specifications.
• Development and maintenance of a build schedules to meet internal and external demand based on product expiry and company demand plan.
• Performing receipt, inspection, and inventory management of facility material, including manufacturing products and consumables.
• Assisting in the transfer of new products/processes to the Microbiology Manufacturing.
• Assurance of product, laboratory, and personnel safety including training and compliance to aseptic technique.
• Analyze procedures and production methods to improve quality, cost, and productivity while keeping within product specifications, good manufacturing practices, Federal safety regulations and Company policies.
• Recommend suppliers for qualification and/or disqualification based on quality performance.
• Generate and manage Deviations and NCRs for non-compliant materials and processes.
• Support commercial scale up.
• Use of an ERP system to manage inventory, set up demand, and manage work orders.
• Performs other duties as assigned.

REQUIRED EXPERIENCE:

• Bachelor’s degree in Biology, Chemistry, or related field or comparable industry experience.
• 2-6 years of Microbiology experience.
• 4-6 years industry experience
• Must have experience in a regulated environment, GMP, ISO, FDA, and aseptic techniques.
• Experience with handling human blood a plus.
• Excellent organizational, record keeping and communication skills (oral and written).
• A strong work ethic to generate high quality work under tight deadlines, collaborative and proactive attitude.

Required Skills Required Experience

*Required

• Ability to work independently and within a team environment and show initiative to take on responsibility*
• Decision making, research and analytical problem-solving skills*
• Time management with the ability to organize, assess and prioritize multiple tasks, projects, and demands, and to work independently*
• Strong verbal and written communication skills and effective interaction at all levels within the organization*
• Familiarity with Bluebeam or Adobe PDF Editor