Director, Analytical Development

Director, Analytical Development

Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. The Director, Analytical Development will provide technical leadership and lead a team of analytical scientists in support of biologics clinical development programs. In addition, the individual will collaborate closely with internal process development, manufacturing, and quality groups as well as clients to help ensure successful delivery of programs. This position is onsite based at Curia Biologics' manufacturing facility in Hopkinton, MA and reports to the Senior Director of Technical Operations. We proudly offer generous benefit options, paid training, vacation and holidays, career advancement opportunities, education reimbursement, 401K program with matching contributions, learning platform, and more!

Supervisory responsibilities :

• Leads multi-faceted programs and direct others.
• Build collaborative relationships with key internal team members, stakeholders (Process Development, Manufacturing, and Quality) and external customers.
• Oversee analytical method development, transfers, validation for critical raw materials, drug substance.
• In-depth knowledge of analytical methods and validations used to characterize proteins such as cIEF, CE-SDS reduced / nonreduced, SEC-HPLC.
• In-depth knowledge of analytical techniques and method validations used to characterize RNA such as Sequence, intactness, capping efficiency, poly(A) tail length, ds RNA impurity, aggregates, %fragments, residual DNA, free nucleosides.
• Familiar with analytical techniques used to characterize protein bioproducts such as titer, host cell DNA size, conformational structure, PTMs, charge variants / deaminidation, peptide mapping, glycosylation, intact mass, protein integrity, oligomeric form, epitope mapping, disulfide formation / free thiols, thermal melting points, PI, capping.
• Review and approval of relevant analytical documents including method validation protocols and reports, specifications, comparability protocols, and provide guidance to team on various technical issues.
• Troubleshoot analytical equipment / assay issues, drive mitigation activities for equipment.
• Provide technical support to clients for regulatory filings, change control and quality impact assessments.
• Develop technical plan for testing across multiple departments, external vendors and other Curia sites.
• Keep site informed for new regulatory, ICH requirements in RNA, proteins and other biological areas.

Qualifications :

Knowledge, skills and abilities :

Education, experience, location and tenure may be considered along with internal equity when job offers are extended. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.