Director CMC Operations @Alira Health Boston, LLC

[Hiring] Director CMC Operations @Alira Health Boston, LLC

Mar 28, 2025 - Alira Health Boston, LLC is hiring a remote Director CMC Operations. 💸 Salary: includes salary, bonus, 401k, health benefits, and equity. 📍Location: USA.

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Role Description

The CMC team within Alira Health Boston LLC advises and assists biotechnology companies to manufacture therapeutic biologics for clinical testing. It seeks an experienced individual to serve as a technical leader and senior consultant in process development and biomanufacturing.

Serve on interdisciplinary client project teams to represent process development and manufacturing.
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.
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).
Recognize risk and propose contingency plans.
Participate in investigations of manufactured product to assure appropriateness and completeness of required documentation.

Qualifications

BS/MS/PhD in molecular and cell biology, biochemistry or biochemical engineering.
10+ years’ experience in CMC related biologics development and manufacturing roles.
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.
Experience in consulting.
Good manager of people with 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.
Excellent verbal and written communication skills, including the ability to generate reports and regulatory documents.
Proficiency with Microsoft Word, Excel and PowerPoint required.

Requirements

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 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.

Benefits

Compensation package will include salary, bonus, 401k, health benefits and equity in the company.

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Director CMC Operations @Alira Health Boston, LLC

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Salary 💸 includes salary, bonus, 401k, health benefits, and equity	Remote Location USA
Job Type full-time	Posted Mar 28, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Director CMC Operations @Alira Health Boston, LLC

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