Careers

Position, duties and responsibilities:

• Participate in the design, development and execution of nucleic acids, lipids, and lipid nanoparticle, analytics.
• Develop protocols for mRNA and lipid nanoparticle analytics using a wide range of techniques including but not limited to Fragment Analyzer, CE, LC/MS, PCR (qPCR, ddPCR), ELISA, SDS-PAGE, DLS, and cell-based assays.
• Support routine testing of mRNA as needed.
• Support other team members in troubleshooting and resolving scientific issues.
• Record, analyze and present experimental data.
• Work cross-functionally with other groups.

Qualifications and Experience

• BSc or MSc with relevant industry experience in analytical development, and/ or related fields
• Industry experience- 1 year minimum.
• Experience in mRNA or RNA analytics.
• Writing reports and SOPs.
• Excellent interpersonal skills, can-do attitude, mission driven with attention to details and troubleshooting mindset.
• Outstanding teamwork, able to work effectively in a dynamic, fast-paced and a fast-growing environment.
• Flexible to shifting priorities and variable workloads.

Work Structure

• 100% of time in Watertown Lab (not hybrid)
• General ability to flex work time/days to account for meetings across time zones.

Apply Here

Position, duties and responsibilities

Exsilio is seeking a Scientist, Analytical Development, to join our team and will help advance pharmaceutical development projects throughout the IND-enabling and clinical development stages for Exsilio’s programs. You will use your leadership and scientific expertise to support all CMC analytical development activities to help grow our pipeline, and aid in the partnership with CDMOs.

• Develop a method development platform to address unique challenges intesting methods for nucleic acids, lipids, & lipid nanoparticles.
• Accountable for phase-appropriate development and validation of critical test methodologies, including HPLC, bioanalytical, biophysical, and genomic assays.
• Characterize drug substance and drug product-related impurities.
• Design and monitor ICH stability programs for drug substance and drug product.
• Manage day-to-day analytical development and testing activities at CDMOs and contract test labs to ensure that projects remain on track.
• Contribute to implementing and operating analytical capabilities. Partner closely with CMC colleagues and QA to (i) write or review test methods, SOPs, analytical data summaries (CoT/CoA), protocols, and technical reports, (ii) critically review, trend, and interpret analytical testing results, and (iii) support investigation of nonconformances (OOS/OOT results, deviations, etc.).
• Communicate and present analytical data in CMC meetings and other cross-functional settings.
• Author CMC analytical sections in INDs and other regulatory filings.
• Collaborate effectively with internal and external stakeholders to deliver on program objectives.

Qualifications and Experience

• PhD in Analytical Chemistry or related life sciences field is preferred, but not required.
• 5+ years of experience in CMC analytical development.
• Strong problem-solving and troubleshooting skills.
• Demonstrated leadership, planning and organizational skills.
• Excellent oral and written communication skills geared to all levels of the organization.
• Demonstrated analytical development experience in drug substance and/or drug product
• Experience in developing impurity control strategies.
• In-depth expertise in test method development, method qualification/ transfer, and characterization of small-molecule drugs during all phases of clinical development.
• Broad analytics expertise with widely employed techniques – biochemical, biophysical, bioanalytical, and cell-based. E.g. Fragment Analyzer, CE, LC/MS, PCR (qPCR, ddPCR), ELISA, SDS-PAGE, DLS, and cell-based assays.
• Knowledgeable of compendial testing methods (USP/EP) used for DS and DP testing.
• Capable of designing, implementing, and managing cGMP stability studies for DS and DP at external labs.
• Strong working knowledge of GLP, cGMP, and ICH requirements.
• Prior experience writing analytical sections in IND/IMPD filings a plus.
• Experience providing technical guidance to CDMOs and contract test labs.
• Experience working cross-functionally among project teams, including internal groups and external CDMOs.

Work Structure:

• 100% of time in Lab, Watertown MA
• General ability to flex work time/days to account for meetings across time zones.

Apply Here