Principal Scientist, Analytical Development
About The Position
This position will serve as the analytical lead for multiple projects, with a focus on oligonucleotides and/or bioconjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify testing methods used to control raw materials, in process, intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques and platforms. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.
Requirements
- BS/BA in Analytical Chemistry/Biochemistry or related discipline and 15+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
- Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
- Experience and expertise with oligos and/or bioconjugate compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterization
- Excellent interpersonal skills with strong oral and written communication abilities
- Excellent laboratory and productivity skills
- Proficient in characterization of oligos and/or antibody oligo conjugate (AOC) using various modern technologies. They may include but are not limited to LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, MS/MS
- Method development, validation, qualification, and transfer experience in Analytical Development
- Comprehensive understanding of cGMP requirements in drug substance and drug product
- Expert knowledge of cross-functional understanding related to drug development
- Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
Responsibilities
- Lead analytical development activities for analysis and characterization of oligos and/or antibody oligo conjugate (AOC) utilizing IP-RP, AEX, LC-MS, MS/MS, SEC techniques
- Lead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercialization
- Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
- Conduct laboratory work independently and/or train lab personnel within the company and at external vendors
- Ensure safe laboratory practices
- Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
- Support off-site analytical transfers, manufacturing support, and interaction with contractors
- Authorize analytical related CMC regulatory documents and lead the supporting work
- Leverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategies
- Contribute to development of policies and department strategies
- Build and enhance internal and external professional relationships
- Support career development and technical growth of team members
- Present finding at varying levels across the company
- Other duties as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
