Head of Cmc

vor 3 Wochen

Aachen, Deutschland LenioBio GmbH Vollzeit

**Job description**:
**We are seeking an experienced CMC professional to assume the pivotal role of Head of CMC, responsible for spearheading the continuous improvement and enhancing the quality of our service offering. Reporting directly to the Chief Executive Officer, you will play a crucial part in establishing a high-performance Process and Operations organization, encompassing manufacturing, quality, MSAT, engineering, and supply management.**

**If you are a results-oriented, proactive problem solver with at least 5 years of valuable pharmaceutical experience, you could be the perfect fit for this position.**

**About this job**:

- The Head CMC will be expected to provide the vision to deliver continuous improvement in quality and service offering, providing the opportunity for the business to deliver profitable and sustainable growth.
- Provide leadership and build a high-performance process and Operations organization including Manufacturing, Quality, MSAT, Engineering, Supply Chain.
- Proficiency in planning, cross-functional performance management, people dynamic management, and technical leadership. (Note: reporting line of Quality unit will be reviewed prior to first commercial supply).
- Develops, oversees, and takes responsibility for CMC operational budgets and resource planning to meet business objectives. Monitors and drives cost efficiencies and productivity output.
- Leads and manages relationships with CDMO partners and suppliers, and administers contracts with key contractors, consultants, suppliers, and CMO‘s. Performs on-site visits to key suppliers.
- Builds and maintains strong relationships with all external and internal stakeholders, including corporate partners, to ensure that performance targets are met or exceeded.
- Ensures the facility delivers high quality products, on-time to customers. Including monitoring and implementing change based upon team reporting, customer feedback and audits, with a view to ensuring operational practices are consistently compliant with regulation and EHS (Environment, Health, Safety) standards and areas for improvement noted and actioned.
- Prepares and reviews Technical/Quality Agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of these activities.
- Develops a robust product supply chain, enacts appropriate risk mitigation procedures.
- Provides guidance, mentoring, and development of internal CMC teams, and ensures the teams have appropriate skills, capabilities, and resources to meet current and future business needs.
- Ensures all development, manufacturing, method and process validation activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
- Authors, reviews and edits CMC sections and provides input into regulatory submissions and regulatory approvals (e.g., IND, BLA).
- Participates in and represents CMC in meetings with global regulatory agencies.
- Discusses and presents CMC information and manufacturing plans/updates to the Executive team, the Board of Directors, and corporate partners, as required.
- Ensure cross-functional communication and integration.

**Requirements**:

- Master Degree in chemistry, pharmaceutical sciences or a related discipline with at least >5 years of pharmaceutical product/process development and/or commercial manufacturing experience in biologics.
- Experience in managing multiple functions such as upstream/downstream manufacturing, engineering and supply chain.
- Demonstrated experience in building and leading exceptional and high performing teams of CMC scientists and/or engineers. Leadership qualities in developing high performance teams, cross-functional engagement and influence. Delivering results within tight project deadlines.
- Proven experience of biologics in various stages of development (pre-clinical to commercialization). Experience preparing and updating regulatory filings (IND, BLA, MAA).
- In-depth experience with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation.
- Strong knowledge of GLP and cGMP, worldwide regulatory requirements, current industry practices and biologics CMC activities.
- Demonstrated ability to select and manage CDMOs for scale up from pilot-scale through commercial manufacturing, including contract negotiation.
- Demonstrated expertise in taking a product through to late stage clinical testing and subsequent commercial launch would be desirable. Specific experience with the scale up and development of biologics.
- Outstanding verbal, written, and presentation skills in English.
- Demonstrable experience working successfully with external pharma partners is highly desirable.
- Ability to accommodate domestic and international travel.
- Proven track record in establishing best project management practices f

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