Director of CMC Operations

Arlesheim - Switzerland

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Alentis Therapeutics the Claudin-1 Company is on a mission to treat cancer and reverse fibrosis. To this end we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney liver and lung fibrosis.

Tasks

The Director of CMC Operations will oversee and optimize the CMC operations for Alentis pipeline products including monoclonal antibodies and antibody-drug conjugates. Acting as a key operational leader and reference for cross-functional teams this role drives operational excellence by aligning timelines supply plans budget and strategic priorities with company goals across multiple programs.

Your tasks:

Oversee and coordinate CMC operational activities for monoclonal antibodies and antibody-drug conjugates CMC programs ensuring alignment with strategic regulatory and operational objectives
Act as the primary operational liaison to the Head of CMC providing regular progress updates clear reporting and guidance for effective strategy execution and decision-making
Drive project management ensuring adherence to required supply plans timelines and operational budget while maintaining compliance with applicable quality and regulatory standards
Ensure seamless communication and information flow between cross-functional teams including Project Management Quality Clinical and Regulatory Affairs
Provide scientific and technical support perform data analysis and document review
Proactively identify operational risks and implement mitigation strategies
Support due diligence activities
Manage justify and track program budget requests and expenditures
Lead process improvement initiatives to enhance efficiency productivity and compliance across all CMC operations

Requirements

PhD Degree in Life Sciences Biotechnology Pharmacy Pharmaceutical Sciences Chemistry or a related field
10 years of experience in leading CMC operations in biologics/ pharmaceuticals including direct report management
Strong organizational and project management skills with the ability to respond to changing priorities prioritize tasks and manage multiple programs in parallel
Excellent written and oral communication skills with the ability to present complex information clearly to both internal and external stakeholders
Significant ability to review technical documentation extract key insights and translate them into actionable items for reporting and decision-making
Good expertise in creating clear concise and visually effective summaries reports and presentations for leadership and cross-functional teams
Proficient computer skills
Deep understanding of CMC regulatory requirements and alignment with operational execution
Experience with accelerated pathways and technology transfer activities is desirable
Proactive and able to work independently with strong problem-solving skills good interpersonal communication and multicultural awareness

Benefits

We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team please submit your CV.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil Switzerland with 2 days home office per week.

Tasks

Your tasks:

Oversee and coordinate CMC operational activities for monoclonal antibodies and antibody-drug conjugates CMC programs ensuring alignment with strategic regulatory and operational objectives
Act as the primary operational liaison to the Head of CMC providing regular progress updates clear reporting and guidance for effective strategy execution and decision-making
Drive project management ensuring adherence to required supply plans timelines and operational budget while maintaining compliance with applicable quality and regulatory standards
Ensure seamless communication and information flow between cross-functional teams including Project Management Quality Clinical and Regulatory Affairs
Provide scientific and technical support perform data analysis and document review
Proactively identify operational risks and implement mitigation strategies
Support due diligence activities
Manage justify and track program budget requests and expenditures
Lead process improvement initiatives to enhance efficiency productivity and compliance across all CMC operations

Requirements

PhD Degree in Life Sciences Biotechnology Pharmacy Pharmaceutical Sciences Chemistry or a related field
10 years of experience in leading CMC operations in biologics/ pharmaceuticals including direct report management
Strong organizational and project management skills with the ability to respond to changing priorities prioritize tasks and manage multiple programs in parallel
Excellent written and oral communication skills with the ability to present complex information clearly to both internal and external stakeholders
Significant ability to review technical documentation extract key insights and translate them into actionable items for reporting and decision-making
Good expertise in creating clear concise and visually effective summaries reports and presentations for leadership and cross-functional teams
Proficient computer skills
Deep understanding of CMC regulatory requirements and alignment with operational execution
Experience with accelerated pathways and technology transfer activities is desirable
Proactive and able to work independently with strong problem-solving skills good interpersonal communication and multicultural awareness

Benefits

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil Switzerland with 2 days home office per week.