Production role in consumables, kit or reagent manufacturing responsible for meeting production schedules in a fast-paced, high throughput industrial setting. This may include the production of coated plates, chemical buffers, biological diluents/reagents and/or assembled kits for customer order fulfillment. Some degree of professional latitude, creativity and self management is expected. This position may manage very specific aspects of the manufacturing process within the department.
DUTIES AND RESPONSIBILITIES:
Program, operate and troubleshoot automated equipment used to perform and produce biological assays and/or reagents.
Contribute to process improvement, assay and process development for manufacturing.
Manufacture custom and/or prototype requests for customers.
Complete appropriate documentation to support process and production procedures including data capture, forms, logbooks, and inventory batch records.
Daily maintenance and documentation of all production equipment.
Develop reports and present information to appropriate stakeholders.
Develop and implement SOPs.
Participation in general maintenance including maintaining laboratory supplies and equipment.
Maintain physical inventory by processing/aliquotting/vialing/labeling materials.
Prepare, update and report raw material, reagent and/or coated plate inventories.
Participate in year-end physical inventory.
Follow laboratory safety precautions and use of personal protective equipment.
May occasionally handle BSL2 reagents.
May provide training for co-workers.
Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS:
Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering or related field is required.
Minimum of 2 years of experience manufacturing biological products.
Experience with MRP or ERP systems is preferred.
Experience with JDE is preferred.
Ability to learn additional software applications/tools, as required.
Experience with cGMP and/or ISO certification is highly preferred.
Desirable skill sets may include but not be limited to the following:
High throughput screening.
Manufacturing immunoassays and/or reagents.
Reagent stability testing.
In-vitro diagnostic instrumentation and devices.
A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration.
KNOWLEDGE, SKILLS AND ABILITIES:
Strong scientific fundamentals and analytical background.
Demonstrate an aptitude for learning and adhering to standard laboratory techniques and safety precautions as presented (protein determination/pipetting/balance operation).
Demonstrated ability to work with automated vialing or bottling equipment.
Independently execute mechanical equipment troubleshooting.
Excellent oral, written communication and interpersonal skills.
Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
Proficiency in MS Office Suite.
Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities.
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.
Standard industrial laboratory, logistics and/or cleanroom environment.