Project Management Associate

Eurofins USA Genomic Services; Louisville (KY); On-site; USD 57,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Genomic Services seeks a Project Management Associate for the Oligo Production line to drive projects, meet production goals, and ensure quality and cost objectives. The role is full-time onsite in Louisville, KY, Monday to Friday, with responsibilities spanning team leadership, KPI tracking, and process improvements.

Ideal candidates will have a Bachelor's in a relevant science/engineering field and at least 1 year in manufacturing or oligonucleotide work, plus strong GMP/ISO

Qualifications

• Bachelor’s degree in engineering, chemistry, biochemistry, or similar field.
• At least 1 year in manufacturing or oligonucleotide field.
• Proficiency in organic synthesis and purification techniques.
• Strong organization and planning skills.
• Working knowledge of GMP, ISO, and QSR regulations.
• Experience documenting and analyzing experimental data.
• Strong computer, scientific, and organizational skills.
• Excellent communication (oral and written) and attention to detail.

Responsibilities

• Lead teams including Supervisors, Team Leads, Production Chemists, Lab Technicians, and contractors.
• Coordinate project activities with timelines, cost, and implementation.
• Manage Red Folder/VIP customer list projects.
• Develop schedules and monitor KPI progress (Safety/Quality/TAT/5S).
• Prepare KPI reports and communicate with management.
• Coach subordinates on performance and development.
• Lead validation activities for new projects and equipment.
• Maintain current BOMs and manufacturing documents in the electronic system.

Skills

Communication

Planning

Attention to detail

GMP knowledge

Documentation

Analytical skills

Education

Bachelor's degree in engineering, chemistry, biochemistry, or similar field

Tools

MS/HPLC data

Job description

Job Description

The Project Management Associate of Oligo Production is responsible for the oligonucleotide manufacturing operation and implementation of key customer projects to meet production goals, quality, and cost objectives. Perform activities in concordance with FDA-QMS/QSR and ISO-9001 standards; ensure compliance with environmental, health and safety regulations. Select, develop, and evaluates personnel to ensure the efficient operation of the function. Plan and administer procedures and budget, serve as a manufacturing representative and technical expert. This position is full time onsite in Louisville KY, Monday to Friday.

** RESPONSIBILITIES:

• Leads the teams and manages individual contributors (Supervisor, Team Leads, Production Chemists, Lab Technicians, contractors).


• Coordinates the activities of project(s) with responsibility for results in terms of timelines, cost, process implementation and employees.


• Manages Red Folder/ VIP customer list projects


• Works on problems of diverse scope including multiple projects and/or objectives.


• Develops and administers schedules and monitors progress (KPI) against objectives. Safety/Quality/TAT/5S


• Prepares KPI reports and communicate regularly with other managers, upper management, and other designated contacts within the organization.


• Coaches subordinate(s) on job performance and development.


• Leads validation activities of new projects and equipment.


• Leads Kaizen and other improvement projects within department.


• Ensures BOMs and manufacturing documents are current, effective and maintained properly in electronic document management system.


• Reviews weekly KPI reports


• Coordinates weekly safety training and recruitment process within department.


• Ensures and adheres to GMP compliance and maintain a clean/ traceable work environment.


• Production Schedule Alignment (Outline deadline requirements for Production, and follow up with schedule to make sure deadlines are met)


• Point of contact for QC questions regarding RF/VIP projects (reviewing MS/HPLC traces before passing to next production step)


• Provide updates/ Delays on RF projects (Tracking for RF and VIP projects)


• Perform activities in concordance with FDA-QMS/QSR and ISO-9001 standards

Qualifications:
Qualifications

• A minimum of a Bachelor’s degree in engineering, chemistry, biochemistry, or similar field.


• A minimum of 1 years of experience in manufacturing or oligonucleotide field or similar field.


• Proficiency of organic synthesis and purification techniques.


• Effective organization and planning skills.


• Working knowledge of GMP, ISO, and QSR regulations.


• Experience in documenting and analyzing experimental data


• Strong computer, scientific, and organization skills


• Excellent communication (oral and written), and attention to detail

Additional Information

Schedule:

• Monday-Friday 8am-5pm

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options


• Life and disability insurance


• 401(k) with company match


• Paid vacation and holidays

Eurofins USA Genomic Services is a Disabled and Veteran Equal Employment Opportunity employer.