Product Transfer Assoc I

POSITION SUMMARY:

This position is responsible for manufacturing assay kit components during development phases, meeting production schedules and troubleshooting. The role is cross-disciplinary and requires coordination across multiple departments (Operations, Quality, Research & Development, etc).

DUTIES AND RESPONSIBILITIES:

• Manufacture custom and/or prototype requests for internal and external customers.
• Operate multiple production lines (Plate, Reagent and/or BioChemical manufacturing).
• Assist with operating and troubleshooting automated equipment used to perform and produce biological assays/reagents.
• Contribute to process improvement, assay and process development for new and existing products.
• Provide complete documentation that supports process and production procedures that includes, but is not limited to data entry, form creation, log entries, and inventory batch records.
• Assist with drafting of standard operating procedures and batch records for new products, if necessary.
• File deviations, variances and non-conformance reports as needed.
• Assist with development of presentations/reports regarding product development issues for internal use.
• Maintain laboratory cleanliness, supplies and equipment.
• Perform daily maintenance and documentation for all production equipment.Maintain physical inventory by processing/aliquotting/vialing/labeling materials.
• Prepare, maintain and report raw material, reagent and/or coated plate inventories.
• Participate in year-end physical inventory.
• As needed, provide training to Operations colleagues on new processes.
• May occasionally handle BSL2 reagents.
• Specific duties may vary depending upon departmental requirements.
• Assist production groups during periods of high demand

EXPERIENCE AND QUALIFICATIONS:

• Bachelor degree in Biology, Chemistry, Biotechnology, Engineering or related field, or associate’s degree with equivalent experience.
• One year of relevant experience desired.
• Experience working independently in manufacturing or research lab highly preferred

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrate an aptitude for learning new processes, collaborating with multiple departments , adhering to standard laboratory techniques and safety precautions as presented

• Knowledge of scientific fundamentals and possess a strong analytical background

• Knowledge of automated equipment function and use

  • Mechanical aptitude including equipment troubleshooting

• Excellent oral, written communication and interpersonal skills

• Knowledge of MRP or ERP systems preferred

• Knowledge of JDE preferred

• Knowledge of cGMP and/or ISO 9001 standard is highly preferred

• Proficiency using MS Office

• Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities

PHYSICAL DEMANDS:

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and frequent lifting up to 50 lbs.
• Up to 80% of the day may be spent at a lab bench and/or in the cleanroom

WORK ENVIRONMENT:

Standard industrial laboratory, logistics and/or cleanroom environment

Education

• Bachelor of Science or better in Biology or related field
• Bachelor of Science or better in Chemistry or related field