Senior/Principal Scientist, Analytical/Formulation
aTyr Pharma is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. aTyr is publicly traded on Nasdaq under the symbol “LIFE”. For more information, please visit http://www.atyrpharma.com.
Patients and their challenges provide tremendous drive and meaning to what we do at aTyr. We seek a talented and successful individual that deeply desires to participate in our process to make medicines that change a patient’s life forever.
This position within the Process Sciences group is for an analytical technical lead to perform internal method development, product characterization/formulation activities and serve as the sponsor point of contact and Analytical subject matter expert with contract research and/or development and manufacturing organizations (CROs/CDMOs). Areas of responsibilities with CROs/CDMOs include overseeing analytical method development, qualification, and validation; and
formulation and stability studies.
- Experience with analytical method development and qualification including release assays and stability-indicating assays such as HIAC, cIEF, CE-SDS; forced-degradation studies to generate and characterize impurities and elucidate degradation pathways
- Thorough knowledge of separation science including HPLC/UPLC (RP, IEX, SEC) and LC-MS TOF, preferably with Agilent and Waters instruments
- Broad knowledge of analytical methods and biophysical characterization methods used in the development of biologics including but not limited to primary, secondary and tertiary structural analysis and structure-function relationship
- Experience with side-by-side comparability analysis of bio-therapeutics due to manufacturing changes
- Software experience with Chemstation, Empower, Mass Hunter, GPMAW, and knowledge of bioinformatics and structural biology
- Documents experiments, results and findings in laboratory notebook; presents work at internal and external meetings; participates in the writing of technical reports, SOPs, and analytical method protocols
- Provides the data in a quality presentation form (graphs, figures, tables, etc.) and authors regulatory submissions and peer-reviewed publications
- Participates in the general lab and instrument maintenance
Experience and Education Requirements
- BS, MS, or PhD with at least 15, 10, or 5 years, respectively, of experience in drug development industry
- Must be extremely detail-oriented, thorough, and diligent
- Excellent organizational skills and ability to execute on multiple projects in parallel
- Excellent written and verbal communication skills
- High level of independence, initiative, and creativity
- Previous experience with mass spectrometry with biologics and HPLC method development required
- Excellent wet-bench (pipetting, analytical assays) and documentation (lab notebook, protocol and data filing) skills
- Familiarity with MS Office software (Excel, Word and PowerPoint)
- Prior experience with cGMP requirements, CRO/CDMO management and tech transfer, analytical method development, qualification/validation, characterization of in-process samples, writing SOPs, and regulatory submission documents is highly desirable
- Experience with pre-formulation/formulation development design and execution also desirable
Further Recruiting Information
For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.
In addition to a competitive compensation package with stock options and an Employee Stock Purchase Plan, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) matching contribution.
For consideration, please submit your resume and cover letter referencing job 160DL to email@example.com.
aTyr Pharma, Inc. is an EEO employer.