Formulation Specialist I

Position Summary 

A Production Associate I is responsible for meeting production schedules in a fast-paced, high throughput industrial setting. This may include the production immunoassay components, chemical buffers, biological diluents/reagents, coated plates, and/or assembled kits, for customer order fulfillment. They will be responsible, under supervision, to follow established SOPs in order to support the goals of the department. 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.

Roles and Responsibilities include: 

• 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
• Participation in general maintenance including maintaining laboratory supplies and equipment
• Maintain physical and electronic inventory by processing/aliquoting/vialing/labeling materials and updating the inventory management system
• Prepare, update, and report raw material, reagent and/or coated plate inventories
• Follow laboratory safety precautions and use of personal protective equipment
• May occasionally handle BSL2 reagents
• Specific duties may vary depending upon departmental requirements

Education: 

• Bachelor’s degree in Biology, Chemistry, Biotechnology, or related field is required 

Experience: 

• 0-2 years of experience manufacturing biological products or a related field 
• 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 

Required Skills: 

• 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) 
• Excellent oral, written communication and interpersonal skills  
• Proficiency in MS Office Suite  
• Ability to work independently or as part of a team 
• Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities