Process Development Associate Jobs in Chapel Hill, NC

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries.

• Bring transformative therapeutics to patients in need.

• Provide an environment for employees to reach their fullest potential.

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

• Embrace Responsibility. We are humbled by the enormity of our mission.We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.

Position Summary

This strategic role leads independent initiatives to optimize DNA manufacturability, quality, and scalable production. The successful candidate will be accountable for the rational design and technical review of DNA constructs that serve as critical starting material for rAAV manufacturing. This role drives process understanding by linking DNA design to process performance and vector quality while generating summary technical documentation and fostering a collaborative culture of scientific excellence.

This position is based on-site in Research Triangle Park (RTP), North Carolina, and reports to the Process Development Associate Director/Director.

Job Responsibilities

• Independently design and execute project initiatives to improve DNA manufacturability and quality with good judgement against defined timelines

• Rationally design and test DNA constructs to increase DNA and rAAV manufacturing productivity and/or improved DNA and vector quality

• Provide subject matter expertise on development of new and/or improved methodologies for DNA production that is fit for purpose (scale, yield etc)

• Lead AskBio CMDO collaborations to improve DNA manufacturing and transfer of relevant processes

• Serve as a technical consultant on DNA starting materials used for Chemistry, Manufacturing and Control (CMC) activities and regulatory strategis, when applicable

• Lead investigations and troubleshooting of DNA purification and analytical characterization as needed

• Represent the DNA Development function in project teams and present data at internal and external forums

• Author technical and development documents, including relevant regulatory submission sections

• Excellent team player who develops and encourages a team environment within the company's mission and values

• Mentors and develops team members by establishing a collaborative and growth minded culture that encourages personal and professional development

• Perform hands-on experiments, when necessary, while maintaining and promoting a clean, efficient, and safe laboratory environment

Minimum Requirements

• PhD (Molecular Biology, Genetics, Virology or equivalent) with 5+ years of relevant work experience including post-doc experience; or MS (Molecular Biology, Genetics, Virology or equivalent) with 10+ years of relevant work experience

• Expertise in viral gene therapy, including recombinant adeno-associated virus systems

• Strong, comprehensive understanding of the molecular attributes that influence both DNA replication in bacteria and rAAV production in mammalian culture

• Demonstrates self-motivation, strong orginzational acumen, and independent strategic thinking with the versatility to perform effectively in both autonomous and collaborative settings

• Excellent written and verbal communication, work planning, data analysis and record keeping skills

• Good working knowledge of Microsoft Office suite (Word, Outlook, Excel) and SnapGene

Preferred Education, Experience and Skills

• In-depth knowledge of bacterial cell culture (E. coli preferred), establishing bacterial glycerol stocks, DNA purification by commercially relevant methods, and molecular biology techniques such as cloning, PCR, DNA quantification, restriction enzyme digest and Sanger and/or NextGen Sequencing

• Demonstrated technical proficiency with fermenters/bioreactors, AKTA liquid chromatography systems, and tangential flow filtration

• Competnecy with electronic laboratory notebooks

• Applied understanding of rAAV manufacturing

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid jobrelated requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.