The Lead Microbiology Manufacturing Associate will perform day to day production of reagents at our Lexington, MA manufacturing facility. This position is responsible for executing manufacturing protocols, and is a key contributor to executing testing, verification and validation protocols.  

RESPONSIBILITIES:

• Follow industry compliance standards (cGMP, FDA, ISO) for the production of external controls and other cGMP products.
• Execute validation protocols for reagent manufacturing processes.
• Identify potential process improvements for reagent manufacturing processes.
• Aid in execution of technology transfer plans for new products transitioning from Product Development to Manufacturing.
• Aid in troubleshooting technical issues.
• Support implementation of new manufacturing equipment and processes including execution of process capability studies.
• Assist in executing the IQ, OQ and PQ of equipment.
• Support/manage sustaining activities and drive cost reduction.
• Daily manufacturing activities to meet organizational deliverables.

SKILLS AND EXPERIENCE:

• BS degree in Biology with 5-7 years of industry experience.
• 5-7 years of Microbiology experience.
• Strong aseptic technique.
• Excellent organizational, record-keeping, and communication (verbal and written) skills.
• Strong work ethic to generate high quality work under tight deadlines.
• Collaborative and proactive approach a must.
• Self-starter and able to work in a fast-paced environment within a matrix organization.
• A desire to get a product to market.

Required Skills Required Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Work from and follow process specifications, work orders, travelers, station paperwork, blueprints, rework/rejection tags, schedules, Aircraft Production Orders, schematics, layout & modifications sheets, engineering orders, Piper Production Spec (PPS), Piper Material Spec (PMS), Material Review Board, and verbal/written instruction.
• Pull parts from bin; report any noted shortages to Production Control.
• Interpret blueprints/sketches of product specifications to determine sequence and method to assemble and repair sheet metal products.
• Work different gauge and types of sheet metal such as stainless steel or aluminum according to product specifications.
• Load component parts onto jig/fixture.
• Drill, ream, rivet, fit, countersink, adjust, finish, and inspect part.
• Trim, file, grind, deburr, buff, and smooth surfaces.
• Apply brush coat/sealant as required.
• Maintain all necessary records, files, and reports.
• Scrutinize every facet of job and report improper operation, faulty equipment, defective materials, and unusual conditions to Supervisor.
• Requires the use of basic tools and various hand tools as specified by departmental tool list.
• Perform housekeeping chores as department requirements dictate.
• Other duties as assigned by Supervisor.