Manufacturing Specialist II, DNA
Asklepios BioPharmaceutical, Inc. (AskBio)
Summary
The Manufacturing Specialist II, DNA - Preclinical Manufacturing role is responsible for manufacturing and delivering a broad range of research-grade DNA constructs across various production scales to support preclinical research and development activities. The DNA manufactured by the team will support capsid technology development, early product development, intellectual property portfolio, and progression of internal and external early-stage gene therapy programs. This role provides an opportunity to gain industry manufacturing experience while providing opportunities to improve DNA purifications processes.
Job description
Position Summary
The Manufacturing Specialist II, DNA - Preclinical Manufacturing role is responsible for manufacturing and delivering a broad range of research-grade DNA constructs across various production scales to support preclinical research and development activities. The DNA manufactured by the team will support capsid technology development, early product development, intellectual property portfolio, and progression of internal and external early-stage gene therapy programs. This role provides an opportunity to gain industry manufacturing experience while providing opportunities to improve DNA purifications processes.
This role is based onsite in RTP, NC and reports to the Manager, Lab Services and DNA Manufacturing.
Job Responsibilities
- Perform hands-on execution of plasmid purifications to support research grade rAAV manufacturing, technology improvements, and progression of early-stage gene therapy programs.
- Follow batch records and document method procedures in a detailed, organized manner.
- Perform and evaluate data analysis at completion of test method; summarize results and finalize batch records.
- Independently support process investigations, improvements, and optimization activities in collaboration with Senior Research Associate and DNA Process Development group.
- Identify, develop, and implement process improvements such as revisions to SOPs, Batch Records, Analytical Records, Formulation Records and initiating new procedures, when necessary.
- Inventory management of raw materials and laboratory supplies.
- Prepare manufacturing reports and data to present to scientists and management.
- Ensure lab areas are clean and organized, including ensuring equipment, supplies and raw materials are available and ready for use.
Minimum Requirements
- Bachelor's degree in a biological or engineering discipline with 2+ years relevant work experience; or Master's degree in a biological or engineering discipline; or High School Diploma with 6+ years of role relevant work experience
- Experience and/or demonstrated skills with one or more of the following techniques: aseptic technique, making reagents at desired dilutions or concentrations, Restriction Enzyme digest, Gel Electrophoresis, DNA quantitation, identifying annotated features on a plasmid map, bacterial cell culture, centrifugation, filtration, fermentation, and liquid chromatography
- Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive team environment
- Track record of independently delivering and interpreting experimental results
- Excellent verbal and written communication skills with the ability to maintain formal record keeping and interact effectively with internal/external stakeholders
- Comfortable working and learning in a fast-paced team-oriented laboratory environment
- Experience with lab management, fermentation and molecular biology/DNA sequence design and analysis software
Preferred Education, Experience and Skills
- Master's degree in a biological or engineering discipline
- Experience with fermentation
- Experience with SnapGene
Requirements
- Bachelor's degree in a biological or engineering discipline with 2+ years relevant work experience; or Master's degree in a biological or engineering discipline; or High School Diploma with 6+ years of role relevant work experience
- Experience with aseptic technique, reagent preparation, restriction enzyme digest, gel electrophoresis, DNA quantitation, plasmid map annotation, bacterial cell culture, centrifugation, filtration, fermentation, and liquid chromatography
- Strong attention to detail, highly organized, ability to multitask in a fast-paced team environment
- Track record of independently delivering and interpreting experimental results
- Excellent verbal and written communication skills and formal record keeping
- Comfortable working and learning in a fast-paced team-oriented laboratory environment
- Experience with lab management, fermentation and molecular biology/DNA sequence design and analysis software
Company overview
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading clinical-stage biotechnology company specializing in gene therapy development. Founded in 2001 and headquartered in Research Triangle Park, North Carolina, AskBio operates as a wholly owned and independently operated subsidiary of Bayer AG. The company focuses on developing transformative molecular medicines using its proprietary adeno-associated virus (AAV) vector technology platform. AskBio maintains a diverse clinical-stage pipeline targeting neuromuscular, central nervous system, cardiovascular, and metabolic diseases, including programs for congestive heart failure, Parkinson's disease, limb-girdle muscular dystrophy, multiple system atrophy, and Pompe disease. With over 900 employees across five countries and more than 800 patents, AskBio's innovative Pro10™ manufacturing platform and extensive capsid library position it as a pioneer in the gene therapy field. The company's technology has been licensed by major pharmaceutical companies including Pfizer, Takeda, and Novartis, validating its leadership position in advancing genetic medicine.