Manufacturing Specialist

Xtalks; St. Louis (MO); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

401k with employer match

Paid time off

Company stock options

Job summary

Geneoscopy in St. Louis, MO, is seeking a Manufacturing Specialist to execute day-to-day lab-based manufacturing processes for In-Vitro Diagnostic products, including reagents and specimen-collection kits.

The role requires a Bachelor's degree and 1–2 years of manufacturing experience. You will work onsite, uphold GMP standards, document batch records, and collaborate cross-functionally in a fast-paced environment.

Qualifications

• Bachelor's degree required.
• 1–2 years of manufacturing experience preferred.
• Ability to read and understand technical procedures and instructions.
• Capable of monitoring production processes and documenting results.
• Strong communication and collaborative skills.

Responsibilities

• Complete and document manufacturing-related activities to support new In-Vitro Diagnostic products.
• Maintain GMP-compliant product quality per Geneoscopy policies.
• Use problem-solving methods to identify root causes and implement solutions.
• Document batch records accurately and completely.
• Follow calibration and maintenance procedures and document activities.
• Monitor production to ensure efficiency and quality.
• Cross-train and back up receiving/preparing patient samples and general lab setup.
• Other duties as assigned.

Skills

GMP knowledge

Manufacturing

Documentation

Quality assurance

Problem solving

Teamwork

Laboratory safety

cGMP

Education

Bachelor's Degree

Job description

This is an onsite, in-office position at Geneoscopy HQ in St. Louis, Missouri.

The 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 ability to 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

Geneoscopy's Core Values

Ability To Embody Geneoscopy's Beliefs, Philosophies, And Principles

• Integrity - we do the right thing through our words, actions, and behaviors
• Courage - step up, speak up, stand out
• Agility - think and act fast, embracing change
• Passion - for our customers, our people, our work, and for excellence
• Collaboration - our differences are assets

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.

Work Environment

• 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.