Manager of Gene Synthesis & Plasmid Manufacturing

Louisville, KY, USA

Full-time

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

Since 1999, Eurofins Genomics Blue Heron has been a pioneer in the gene synthesis industry and has delivered tens of millions of base pairs of perfectly accurate genes to thousands of customers worldwide using its proprietary GeneMaker® multi-technology platform. We are 100% committed to serving our customers with high quality, strict confidentiality standards, and improved business efficiency. In mid-2019 Blue Heron was acquired by Eurofins Scientific and became a partner of the Eurofins Genomics US division.

Blue Heron is searching for manufacturing Manager to join our team. The manufacturing Manager will report to the President of Blue Heron Biotech and lead the day-to-day operations of the gene synthesis operations at the Blue Heron.

Responsibilities/Accountabilities

• Oversees, directs, coordinates and prioritizes the daily activities related Blue Heron GeneMaker® platform including Gene synthesis, plasmid DNA and IVTmRNA production.

• Plan and organize the production schedule while ensuring compliance with safety regulations

• Recruit, train, develop, and retain staff while ensuring adherence to essential training schedules.

• Identify and analyze problems, develop solutions, and implement corrective actions effectively

• Act as the primary troubleshooting expert for the production group, identifying and resolving technical and operational issues.

• Manage vendor relationships, negotiate pricing, and oversee the ordering and purchasing of production materials and supplies.

• Support the development, implementation, and optimal use of equipment and systems to enhance efficiency, productivity, and profitability at all levels of manufacturing.

• Implement process controls, validations and metrics for the production equipment to monitor the stability of the manufacturing process while maintaining compliance with ISO 13485:2016 standards.

• Ensure Blue Heron manufacturing group complies with all government regulations and industry standards.

Qualifications

• Bachelor's degree or higher in a related scientific discipline required; MS or PhD in Molecular Biology preferred.

• Experience working with LIMS and proficiency in molecular biology techniques required.

• 6+ years of direct manufacturing and operations experience, including at least 3 years of managerial and supervisory responsibilities.

• Hands-on, self-motivated, and highly organized, with a demonstrated ability to lead teams effectively.

• Strong communication and interpersonal skills.

• Experience with manufacturing scale up is preferred.

• Experience with ISO or GMP certification and process is a plus.

• Some experiences in lean six sigma is a plus

Additional Information

Schedule:

• 9:00pm - 6:00pm, Monday-Friday, Sunday to Monday or Tuesday to Saturday

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.