Director, Analytical Development

Lake Pharma-posted 3 months ago
Full-time • Senior
Hopkinton, MA
101-250 employees
Chemical Manufacturing
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Curia is a global contract development and manufacturing organization (CDMO) 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.

  • 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.
  • Indepth knowledge of analytical methods and validations used to characterize proteins such as cIEF, CE-SDS reduced/nonreduced, SEC-HPLC.
  • Indepth 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.
  • Develops 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.
  • Ph.D. in biological sciences, biochemistry, chemical engineering, or related field with a minimum of 8 years of relevant experience. Alternatively, a Bachelor's degree with 15+ years of relevant experience or a Master's degree with 12+ years of relevant experience will be considered.
  • Proven track record of leading analytical development in a GMP-regulated environment and collaborating with operations and Quality teams.
  • Demonstrated success in the development, transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidelines and regulatory requirements.
  • Multiple years of management experience overseeing staff with a variety of skill and educational levels in CDMO environment.
  • Strong knowledge of both physical analytical procedures (HPLC, ELISA, CE, MS, etc.) as well as binding assays and cell-based biological assays.
  • Solid understanding and application of ICH guidelines, GMP principles, data integrity and method transfer.
  • Strong leadership, interpersonal communication, collaboration and problem-solving skills.
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to effectively present information to top management, public groups and/or boards of directors.
  • Flexible and adaptable in constantly changing environments and growing organization.
  • Maintains extremely high quality and efficiency standards.
  • Contribute to the development and maintenance of a positive team-focused company culture.
  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401K program with matching contributions
  • Learning platform
  • And more!
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