Director CMC Operations

Alira Health•Boston, MA

12d

About The Position

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary Job Description Summary The CMC team within Alira Health Boston LLC advises and assists biotechnology companies to manufacture therapeutic biologics for clinical testing. The CMC team offers services in cell line, process and formulation development, quality, regulatory, project management and toxicology. It seeks an experienced individual to serve as a technical leader and senior consultant in process development and biomanufacturing. This is a leadership role to help guide and manage the CMC group, working in partnership with the Senior Vice President. Essential Duties and Responsibilities Responsibilities will include both client advisory and management, with a distribution of roughly 50% time for each. Client Advisory 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. Management 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.

Requirements

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.

Responsibilities

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 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.