Manufacturing Manager

Geneoscopy•St. Louis, MO

8d•Onsite

About The Position

Manufacturing Manager This is an onsite, in-office position at Geneoscopy HQ in St. Louis, Missouri. Geneoscopy is seeking a Manufacturing Manager to oversee all aspects of manufacturing operations for our diagnostic products. This role will be instrumental in developing, validating, and maintaining robust manufacturing processes in alignment with regulatory standards. The ideal candidate will collaborate cross-functionally with internal teams and external suppliers to ensure efficient, compliant, and high-quality product manufacturing.

Requirements

Minimum of 4 years relevant experience in manufacturing, preferably within in-vitro diagnostics or medical device industries.
Proven experience with 21 CFR 820 (QSR) compliance.
Working knowledge of ISO 13485 and ISO 14971 standards.
Experience with manufacturing process development, validation, and scale-up.
Strong organizational and project management skills.
Excellent communication and interpersonal skills for cross-functional collaboration.
Hands-on, proactive mindset with the ability to work in a fast-paced, evolving environment.
Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
Possess high ethics and conduct business in the most professional manner.
Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.

Nice To Haves

Familiarity with Lean Manufacturing or Six Sigma methodologies is a plus.

Responsibilities

Plan, manage, and execute manufacturing schedules and material procurement activities.
Participate in hands-on manufacturing operations to support daily production needs.
Coordinate manufacturing activities in support of product development and commercialization.
Lead process development and validation efforts for new products, internally and with external partners.
Ensure product quality meets or exceeds regulatory and internal quality standards (cGMP/QSR, Geneoscopy policies).
Apply structured problem-solving techniques to identify root causes and implement corrective actions.
Monitor, track, and report key manufacturing and process performance metrics.
Ensure team members are trained and compliant with standard operating procedures and quality requirements.
Support continuous improvement initiatives.
Other duties as assigned.