Manufacturing Specialist

Geneoscopy; St. Louis (MO); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

401k with employer match

Paid time off

Company stock options

Job summary

A diagnostics company in St. Louis is seeking a Manufacturing Specialist to manage laboratory processes for In-Vitro Diagnostic products. Responsibilities include maintaining quality standards, documenting manufacturing activities, and ensuring adherence to GMP. The role requires a Bachelor's degree and ideally 1-2 years of experience in a manufacturing setting. The position offers a competitive salary, bonus, and benefits, including health insurance and stock options.

Qualifications

• 1-2 years' experience within a manufacturing environment.
• Ability to read and understand technical procedures.
• High integrity and accountability.
• Proficient verbal and written communication skills.

Responsibilities

• Complete and document manufacturing activities for new products.
• Maintain product quality per Good Manufacturing Practices (GMP).
• Analyze production issues and implement solutions.
• Document all required batch records.
• Monitor production processes for efficiency and quality.

Skills

Problem-solving techniques

Technical communication

Multitasking

Collaboration

Education

Bachelor's Degree

Job description

Manufacturing Specialist will be responsible for performing day‑to‑day manufacturing processes within the laboratory for Geneoscopy's In‑Vitro Diagnostic products. These processes include manufacturing reagents and consumable specimen‑collection kits.

Responsibilities

• Complete and document manufacturing‑related activities required to support the development and commercialization of new In‑Vitro Diagnostic products.
• Maintain a high standard of product quality in accordance with Good Manufacturing Practices (GMP) and Geneoscopy's policies and procedures.
• Utilize problem‑solving techniques to analyze issues at hand, identify the root cause, and develop/implement solutions.
• Accurately complete all required written documentation for batch records.
• Adhere to the laboratory's instrument calibration and maintenance procedures, and document all procedural maintenance and calibration performed.
• Monitor the production process and evaluate and analyze observations to ensure efficiency and quality.
• Cross‑train and act as backup for receiving and preparing patient samples for testing, as well as general laboratory setup and maintenance activities.
• Other duties as assigned.

Education Requirements

• Bachelor's Degree required.

Qualifications

• Ideally, possess 1‑2 years' experience within a manufacturing environment.
• Demonstrate the ability to read and understand technical procedures and instructions.
• Exemplify the capability to carefully monitor production processes and document results.
• Exemplify the ability to communicate clearly, move quickly, and make technical decisions with limited information.
• Possess a builder's mindset: proactive, collaborative, and comfortable wearing multiple hats.
• Demonstrate high integrity, accountability, and a desire to help shape both the technology and the team.
• 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.
• Preferred Additional Experience:
  • Experience with cGMP processes.
  • Industry knowledge of diagnostics and/or life sciences.
  • Knowledge of biotech manufacturing processes and equipment.
  • Experience with manufacturing automation.

Schedule

This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

Compensation & Benefits

• Base salary range: annually determined based on the candidate's experience, knowledge, and abilities.
• Bonus: discretionary annual bonus based on a percentage of the employee's base salary.
• Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.
• Company stock options.

Physical Demands

• Employees may be required to lift routine office supplies and use standard office equipment.
• Must possess the ability to sit and/or stand for long periods.
• Must possess the ability to perform repetitive motion.
• May have exposure to fumes and bio‑hazardous material in the laboratory environment.
• May be required to handle blood‑borne pathogens and general laboratory reagents.