Senior Scientist, Analytical Development

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

The Senior Scientist, Analytical Development will provide the design, development, qualification and execution of analytical assays to support product and process characterization, process development, MSAT, non-clinical and GMP recombinant Adeno-associated virus (rAAV) vector manufacturing. This individual provides analytical test method development, qualification and validation support along with analytical method tech transfer for future non-GMP and GMP drug substance/product release. Responsibilities include but are not limited to, coordination of intra-team and inter-team efforts, acting as a primary point of contact, and interacting productively with stakeholders. Other responsibilities include the assessment and implementation of new analytical technologies in collaboration with other functional groups.

The Senior Scientist, Analytical Development will report to the Associate Director, Analytical Development and be based in the RTP, NC area.

Job Responsibilities

• Design, establish, develop, qualify and provide validation support for biochemical assays such as ELISAs, HPLC (SEC, RP, IEX), Capillary Electrophoresis, AUC, Mass Photometry, DLS, residuals assays etc.
• Establish timelines associated with multiple analytical development projects. Provide analytical testing support for Process Development, R&D, GMP and external CMO teams to assist in the development and analytical characterization of new therapeutic targets.
• Design and coordinate/execute qualification of developed analytical methods and tech transfer the methods internally and/or to partner CMO
• Use critical analytical thinking to evaluate and draw conclusions on data from device compatibility, product comparability and product stability.
• Author development reports, study protocols, SOPs, pre-validation reports and analytical assay tech transfer documents
• Represent the analytical development team as subject matter expert in cross-site analytical meetings, CMC meetings and assist in authoring CMC-related documentation and responses to health authorities when needed (FDA, EMA, MHRA etc) queries.
• Evaluate CRO/CMO test results and writing summary reports of the results when needed
• Establish CRO relationships when needed
• Contribute to technical discussions and investigations within the analytical group and help support process development, MSAT, QC, non-clinical and GMP manufacturing
• Act independently to define new assignments that generate innovative methods and procedures. Bring in new technologies for characterization of AAV drug products
• Exhibit expert skills in synthesizing research findings and effectively communicating findings and recommendations to senior management independently
• Perform detailed, organized, formal record keeping. Must be able to generate high quality data for presentations and publications
• Manage a group (up to 4 people) of scientists and research associates performing laboratory activities

Minimum Requirements

• MS with 10+ years' experience OR PhD with 5+ years' experience in Bioanalytical Chemistry, Biochemistry, Molecular Biology, Biology, Virology or related field
• Excellent interpersonal skills with the ability to interact effectively with people, internally and externally
• Self-motivated, organized, capable of working independently as well as in a collaborative/group environment.
• Capable of managing a group of analysts/scientists
• Expertise with method development, qualification and validation following regulatory guidelines (USP, ICH etc)
• Excellent oral and written communication skills
• Good judgment and innovation to achieve a solution within standard practices and procedures
• Proven ability to work independently in a fast-paced environment, meet deadlines, and prioritize work on multiple projects
• Strong attention to detail

Preferred Education, Experience and Skills

• Prior industry experience in gene therapy

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 job-related 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 [email protected].

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.