Alira Health · 17 hours ago
Director CMC Operations
Greater Boston
Full-time
Hybrid
Director/Executive
10+ years expAlira Health is a global company dedicated to innovation and collaboration in the biotechnology sector. They are seeking a Director of CMC Operations to lead the CMC team in advising biotechnology companies on the manufacturing of therapeutic biologics for clinical testing, while also managing client relationships and project teams.
BiotechnologyConsultingHealth Care
Responsibilities
Serve on interdisciplinary client project teams to represent process development and manufacturing. Responsibility may include serving as the technical lead for one or more of these teams
Collaborate with colleagues in the CMC group to develop strategies and workflows for bioprocessing including cell line development, process development, and manufacturing
Lead identification and selection of CRO and CDMO partners for development and manufacture of drug substance and drug product through identification of potential partners, preparation of requests for proposal, review of proposals, and creation of detailed itemized proposal comparison
Manage CRO and CDMO relationships on behalf of clients to ensure successful and timely completion of project activities and milestones. Compile, analyze and report results to the client in a clear and concise fashion
Perform due diligence on assets being considered for acquisition by clients
Conduct market assessments and portfolio reviews for CDMOs and technology companies
Lead internal meetings, providing client and technology updates to the group
Draft CMC sections of regulatory submissions (IND/IMPD or other). Responsible for assisting in the creation of CMC documents for IND filings to meet Global Quality standards and applicable regulatory requirements
Recognize risk and propose contingency plans. Collaborate with quality and regulatory colleagues and may interact with regulatory agencies including, but not limited to FDA, EMA, Health Canada. Participate in investigations of manufactured product to assure appropriateness and completeness of required documentation
Manage consulting groups to ensure that they have resources and guidance needed to staff project teams and execute client projects successfully
Manage consulting staff to build competence and skills and to motivate a high level of performance
Understand and monitor business performance metrics to help to achieve financial goals
Support the Vice President of CMC in sourcing of potential new clients and in representing CMC to them. Participate in new client introductions to understand their priorities, and help in the creation of project scope and budget to meet the client’s needs
Qualification
Required
BS/MS/PhD in molecular and cell biology, biochemistry or biochemical engineering combined with 10+ years' experience in CMC related biologics development and manufacturing roles, including demonstrated competence in a leadership role
Specific, in-depth expertise in a technical discipline; focus on manufacturing strategy and operations; knowledge of biologic manufacturing expression systems including both mammalian and microbial strains
Experience managing CRO/CDMO relationships, ideally including running vendor selection processes and contact/scope negotiations
Good understanding of FDA, EU, and ICH cGMP guidelines and industry best practice, with demonstrated ability to apply these to drug substance and drug product operations
Experience in, or at least an understanding of key elements for, successful consulting
Good manager of people
Sound judgment, analytical, problem-solving and decision-making skills
Ability to handle multiple assignments and changing priorities along with fluctuations in workload
Demonstrated planning, project management, negotiation, facilitation and presentation skills
Visible contributions via record of publications and conference presentations in field of biologics development
Ability to work both independently and collaboratively in a team structure. Uses a team-oriented approach to project management and problem resolution. Holds self and others accountable in achieving collective goals
Excellent verbal and written communication skills, including the ability to generate reports and regulatory documents
Proficiency with Microsoft Word, Excel and PowerPoint required
Benefits
Bonus
401k
Health benefits
Equity in the company
Company
Alira Health
Alira Health is an international advisory firm.
501-1000 employees
H1B Sponsorship
Alira Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$233MKey Investors
Symbiotic CapitalCreadev
2024-12-17Debt Financing· $100M
2023-01-09Series Unknown· $58M
2022-01-13Series Unknown· $40M
Leadership Team
Gabriele Brambilla
CEO
Annabel de Maria
Chief Patient Officer
Recent News
GlobeNewswire
2025-12-17
2025-10-23
Company data provided by crunchbase