Director CMC Operations

Position Overview

• Location Type: Onsite (Boston, LLC)
• Employment Type: Full Time
• Salary: Not specified
• Summary: Join Alira Health Boston LLC’s global team, dedicated to innovation and collaboration, where physical limitations are overcome by a shared commitment to values like courage, accountability, honesty, inclusivity, and elevating others. The CMC team advises biotechnology companies on manufacturing therapeutic biologics for clinical testing, offering services in cell line, process, and formulation development, quality, regulatory, project management, and toxicology. This role seeks an experienced individual to serve as a technical leader and senior consultant in process development and biomanufacturing, reporting to the Senior Vice President.

Requirements

• Experience in process development and biomanufacturing.
• Strong understanding of cell line development, process development, and manufacturing.
• Ability to collaborate effectively with interdisciplinary client project teams.
• Experience in CRO/CDMO partner management.
• Ability to draft CMC sections of regulatory submissions (IND/IMPD or other).
• Familiarity with Global Quality standards and applicable regulatory requirements (FDA, EMA, Health Canada).
• Experience in investigations of manufactured product.

Responsibilities

• Client Advisory (50%):
  • Serve on interdisciplinary client project teams as a technical lead.
  • Develop strategies and workflows for bioprocessing.
  • Lead identification and selection of CRO and CDMO partners.
  • Manage CRO/CDMO relationships to ensure successful project completion.
  • Compile, analyze, and report results to clients.
  • Perform due diligence on assets being considered for acquisition.
  • Conduct market assessments and portfolio reviews for CDMOs and technology companies.
  • Lead internal meetings and provide client/technology updates.
  • Draft CMC sections of regulatory submissions (IND/IMPD or other).
  • Assist in the creation of CMC documents for IND filings.
  • Recognize risk and propose contingency plans.
  • Collaborate with quality and regulatory colleagues and interact with regulatory agencies.
• Management (50%):
  • Manage consulting groups to ensure successful project staffing and execution.
  • Build competence and skills within consulting staff.
  • Motivate consulting staff.

Application Instructions

• Not specified.

Company Information

• Company: Alira Health Boston LLC
• Industry: Biotechnology Consulting
• Values: Be courageous, be accountable, be honest, be inclusive, and elevate others.