MRNA Director of Plasmid Production

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements in the United States, Europe and Latin America. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

The Role:

The Director of plasmid production will be providing leadership in internalizing plasmid DNA manufacturing process including upstream and downstream plasmid DNA synthesis, purification, and characterization activities.

In this role you will….

·         Provide leadership in internalizing plasmid DNA manufacturing process including upstream and downstream plasmid DNA synthesis, purification, and characterization activities.

·         Design, develop and implement a robust plasmid scale up workflow including bacterial fermentation, plasmid purification, characterization, and linearization

·         Oversee high-throughput plasmid synthesis and purification workflow while continuously improving the automation platform to meet evolving needs of the business

·         Coordinate data capture and tracking plasmid info with the data science team

·         Build analytical capabilities for plasmid in process testing and characterization assays

·         Write and review SOPs, reports, batch records and approve documentation for plasmid DNA release for use in mRNA production

·         Support process validations and technology transfers

·         Manage, coach and mentor staff to build a highly functional plasmid production team

Requirements

·         Ph.D. or M.S. in a related field (e.g., Chemical Engineering, Biochemical Engineering, Biochemistry, Biotechnology, or other relevant discipline) and 10+ years of relevant experience in a pharmaceutical, biotechnology, Contract Manufacturing Organization (CMO) or a B.S. in in these same disciplines and 15+ years of relevant experience.

·         Experience leading complex, multi-disciplinary projects and teams during biotech drug development

·         Expertise in batch, fed batch fermentation methodologies and plasmid DNA purification using chromatographic methodologies.

·         Expertise in high-throughput plasmid DNA synthesis and purification methodologies

·         Desire to work in a team-first, fast-paced environment, learn new skills, and to efficiently solve problems

·         Must be proficient in E. coli culture, fermentation (small & large scale) and cell banking strategies

·         Experience in gene synthesis, large-scale plasmid purification methodologies including alkali lysis, chromatography separation (anion exchange, hydrophobic/ion pair interaction, size exclusion/Capto Core) and buffer exchange methods such as TFF is a must

·         Knowledge in different cloning techniques, primer design, PCR, qPCR, capillary & gel electrophoresis, and Sanger sequence data analysis is preferred

·         Experience in characterization and analytical method development relevant to plasmid DNA is a plus

·         Expertise in equipment setup, troubleshooting and maintenance and experience in GLP/GMP environment is advantageous

Benefits

Our client offers a comprehensive benefits package including:

401k Matching

Family and Individual Insurance Packages (Health, Life, Dental, and Vision)

Paid Time Off & Paid Holidays

Long & Short-Term Disability

Identity Theft Plans

Retirement & Pension Plans

Employee Assistance Program

Employee Referral Program

Tuition Reimbursement Programs

Advancement & Professional Growth opportunities 

Parental Leave

& More