Scientist I, Analytical Development Biochemistry

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

2d•Onsite

About The Position

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 Scientist I, Analytical Development will contribute to 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 subject matter expert, and interacting productively with stakeholders. Other responsibilities include participating in the assessment and implementation of new analytical technologies in collaboration with other functional groups. The Scientist I, Analytical Development will report to the Senior Scientist, Analytical Development and be based in the RTP, NC area.

Requirements

MS with 6+ years’ experience OR PhD with 0+ 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
Expertise with method development with focus in separations (HPLC, CE-SDS, icIEF , etc.)
Knowledge of 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
Excellent technical laboratory skills with attention to detail and the ability to assume independent ownership of protocols/experiments

Nice To Haves

Prior industry experience in gene therapy
Experience working in a regulated environment with understanding of GDP and GMP requirements.
Knowledge of qualification and validation following regulatory guidelines (USP, ICH etc)

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.
Assist in design and execution of qualification/validation of developed analytical methods and tech transfer the methods internally and/or to partner CMO
Provide analytical testing support for internal and external departments in order to assist in characterization of therapeutic targets
Author development reports, study protocols, SOPs, analytical assay tech transfer documents and any other relevant analytical documents
Evaluate CRO/CMO test results and write summary reports of the results 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 ideas 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
Generate high quality data for presentations and publications
Design and perform experiments independently, provide oversight for junior lab members and work cross-functionally within the organization
Perform detailed review of laboratory notebooks and data analysis
Independently provide effective oversight and management of external vendors