Director, CMC Lead
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, CMC Lead.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Defines and ensures execution of the phase appropriate process, analytical, and manufacturing programs.
- Defines clinical development needs based on non-clinical and clinical study designs and applications.
- Defines life cycle management projects by manufacturing operation development targets.
- Oversees process scale-up and transfer activities.
- Ensures process and product characterization, and comparability after process changes.
- Accounts for the development of the process control strategy including leading development of product specifications in a cross functional team.
- Ensures alignment and communication of CMC strategies, objectives, and deliverables.
- Reports to core project teams, steering committees, and established governance bodies on progress against deliverables, timelines, and project risks.
- Accounts for the delivery of the quality section during clinical development, market authorization, and LCM changes for organization-specific projects.
- Contributes to the strategic aspects of product characterization, comparisons, manufacturing trending, trouble shooting and process changes.
- Maintains line of sight for all other aspects of the development process in validation, QA, QC, and engineering.
- Oversees aspects of site manufacturing delivery (contracts, production, coordination, validation, and regulatory activities).
- Accounts for CMC/QbD related project and product documentation.
- Executes globalization initiatives across sites that drive efficiencies as well a establishes best practices, and returns values to the organization.
- A PhD, Master's, or BSc (or equivalent) in Biochemistry, Biology or related field is required.
- Must have a minimum of 10 years of experience in the pharmaceutical industry with an emphasis on manufacturing operations, process design, and process validation.
- Demonstrated experience in project management and leadership by influence is preferred.
- Knowledge of biological manufacturing processes and advanced CMC requirements for biotechnology therapies is a plus.
- Must have technical and regulatory writing experience.
- Fluency in German is strongly preferred.
- Requires strong leadership skills to lead teams in a global setting, understand needs of customers and stakeholders, use proactive approaches to meet their needs in an effective and timely manner, and to build and maintain effective working relationships.
- Must understand the fundamental patient safety strategies and GMP related aspects for assuring the safety of biological products.
- Understanding of biological product manufacturing requirements and process validation is required.
- Must be able to translate insights into solutions that create value and challenge the status quo.
- The ability to work effectively across varied and different international conditions is required.
- Must be able to identify opportunities and issues and proactively follow through on work activities to capitalize or resolve them.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms