Oligonucleotide Manufacturing Manager at Eurofins Genomics, LLC in Louisville, Kentucky

Job Description:

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 Operations Manager of Oligo Production is responsible for the oligonucleotide manufacturing operation and implementation of activities 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:



Eurofins Genomics is seeking a hands-on leader that will report to the Head of Manufacturing and be responsible for establishing and maintaining accountability and ownership of the Oligonucleotide Manufacturing (OM) operations. This individual will communicate manufacturing management goals and provide visibility for their staff. In addition, they will focus on regulatory and safety compliance as well as direct oversight for manufacturing operations and facilities supporting the manufacturing plant. Major responsibilities include but are not limited to:

• Provide overall direction, coordination, coaching and evaluation of multiple direct reports for a Manufacturing Organization Drive major projects and programs for Organizational Unit or Function to completion within schedule and budget


• Conduct briefings and participate in technical meetings for senior management and external representatives concerning specific operations Collaborate with support groups to reach mutually agreed-upon deadlines


• Manage process changes to support overall cGMP compliance Review and continuously improve the state of operations from fiscal overview to area walk-throughs


• Monitor and continually evaluate opportunities to improve key performance indicators (KPIs) and work with management and cross-functional teams to drive CI projects.


• Identify and report potential operational risks and issues to senior management and lateral operational managers


• Monitor Personnel Cost, Consumable Cost, Overtime hours.


• Represent technical operations for site and interdepartmental meetings.

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


• Maintains skill set matrix for Operations Team


• 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.


• 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.

• A minimum of a Bachelor's degree in engineering, chemistry, biochemistry, or similar field. Ph.D. is highly preferred.


• A minimum of 3 years of managerial 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

• 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


• Monday-Friday 3:00pm-11:30pm