Inanovate, Inc Hiring for Production Manager (Medical Device) Job at Chapel Hill, NC Full Time

Position: Production Manager (Medical Device)

About Inanovate: Inanovate is an early-stage medical device-diagnostics company headquartered in Sioux Falls, South Dakota with engineering and device production operation in Chapel Hill, NC.
Inanovate has developed a breakthrough proteomics platform technology (Bio-ID800/LAS) with an initial laboratory test application focused on monitoring recurrence of breast cancer. We all know someone who has lost the battle to cancer. For breast cancer, following primary diagnosis and treatment, the overall 5-year relative survival rate is over 95%. However, if a patient has a recurrence, the 5-year survival drops to below 25%. At Inanovate we are developing a blood-based test that detects the body’s own autoimmune protein signatures as well as other circulating proteins in the blood to monitor recurrence of cancer at a much earlier and treatable stage. Come join the fight and apply to our open positions in Chapel Hill, NC today.

Position Summary: As the Production Manager at Inanovate working in Chapel Hill-NC you will be responsible for the production processes leading to the BioID Microfluidic Assay Kit for cancer diagnosis. This individual will collaborate in product refinement activities including defining, improving, overseeing manufacturing and quality processes in a cGMP environment.
Responsibilities will include but are not limited to the daily management of the fabrication of assay cartridges and kits, maintaining supply and coordination with third party vendors.

Position Requirements:

• Manage production activities per approved manufacturing directions while maintaining compliance with all job-related SOPs.
• Ensure that all batch paperwork is completed in an accurate, thorough, and in a timely manner.
• Express ideas and feedback clearly through verbal and written communication.
• Assist with executing validation protocols associated with production, platform equipment, and software.
• Assist with the review and revision of SOPs necessary for the manufacture and packaging of product.
• Comply with all safety policies and procedures through safe lab practices, including the appropriate use of Personal Protection Equipment (PPE) as required to perform routine and non-routine duties.
• Proficient in the use of computers and Microsoft Office.
• Maintain work areas in a well-organized, clean, and tidy manner.
• Demonstrate an ability to manage within a small team with constrained resources and overcome unexpected obstacles.
• Perform other duties as assigned by management.

Qualifications:

• A Bachelor’s degree or equivalent in a scientific, technical or process development related field and a minimum of 2-years in a regulated production/operations environment, preferably in the medical device industry.

Preferred Experience:

• Knowledge of FDA and/or cGMP regulations.
• Ability to learn new procedures and equipment and to train staff to a measurable level of expertise.
• Demonstrate ability to manage in a technically demanding environment with several different pieces of equipment.

Additional Information:

• Ability to maintain reliable and punctual attendance.
• Lab work is performed wearing various types of PPE which include, but is not limited to: hairnet, beard cover, safety glasses, closed shoes, gloves, face mask and lab coats.
• Occasional travel (

The compensation package will be commensurate with the experience level of the candidate selected and will include a benefits package and stock options.

Interested candidates should send their resume with a cover letter.

Job Type: Full-time

Pay: $75,000.00 – $125,000.00 per year

Benefits:

• Flexible schedule
• Paid time off

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Chapel Hill, NC 27517: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)
• Management: 1 year (Preferred)

Work Location: One location