6+ years in the biopharmaceutical or medical device industry
AA or AS in Life Sciences or Engineering preferred
Expertise in complex problem-solving and independent task execution
Strong leadership and facilitation skills in a team environment
Responsibilities
Lead a team of Technicians in manufacturing supplies for development and clinical studies
Perform complex tasks to support R&D and development activities independently
Collaborate with R&D and Technical Services to optimize processes
Set up, operate, troubleshoot, and dismantle various manufacturing equipment
Coordinate experimental, clinical, and validation activities
Lead manufacturing process and handle deviations
Assume Supervisor responsibilities in their absence
Create and update SOPs, Production Records, and IOQ documents
Train Technicians on the job and facilitate group training
Maintain a safe work environment and investigate Safety Incident Reports
Liaise with Maintenance and Facilities for equipment upkeep
Communicate critical information between shifts
Benefits
Comprehensive training opportunities
Career development within the biopharmaceutical or medical device field
Opportunity to work with advanced manufacturing technologies
Leadership roles and growth potential within the team
Dynamic and collaborative work environment
Full Job Description
Responsibilities
Lead team of Technicians manufacturing of supplies for development and clinical studies
Independently perform a variety of highly complex tasks to support R&D and development activities
Interact with R&D and Technical Services personnel to provide input and expertise and to assist in the optimization processes
Independently set-up, operate, troubleshoot and dismantle a broad range of equipment (bench-top, medium, large scale used for the manufacturing of Nova Pneuma Inc products
Lead and coordinate the execution of experimental, clinical and process qualification and validation activities
Lead select manufacturing processes and initiate investigations when deviations occur
Assume the responsibilities of Supervisor when absent
Generate and revise SOPs, Production Records and IOQ documents
Provide leadership and direction to Technicians when needed
Provide on-the-job and SOP training including facilitating group training
Ensure a safe work environment is maintained and initiate and investigate Safety Incident Reports when they occur
Interact with Maintenance and Facilities to ensure equipment and facilities are maintained in good working order
Ensure that all pertinent issues are communicated between shifts (as required)
Skills required
As a highly skilled specialist, contributes to the development of concepts and techniques.
Completes complex tasks in creative and effective ways.
Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
Acts independently to determine methods and procedures on new assignments.
Often acts as a facilitator and team leader.
Education and experience
A high school diploma or equivalent experience
6+ years experience in the biopharmaceutical or medical device industry
AA or AS in a Life Sciences or Engineering discipline preferred
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
