Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
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
- 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:
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.