Our client, a global Biopharmaceutical organisation, are currently seeking to hire an Associate Director, Biologics External Manufacturing Operations. You will be responsible for the delivery of outsourced key strategic manufacturing and tech transfer initiatives at a key contract manufacturing organisations (CMOs), including project planning, coordination and external manufacturing oversight.
- To oversee strategic supplier relationship with a key CMOs, managing performance of CMOs to meet requirements for commercial biologics manufactured on site.
- To lead a matrixed team managing daily business at key CMOs.
- To manage matrix relationships with Quality, Regulatory, Manufacturing Science and Technology (MS&T), Procurement, and other partners.
- To establish and track performance against KPI's for safety, quality, customer service, cycle time, inventory and financial targets.
- To monitor vendor performance and proactively identified issues and risk with their operations.
- To oversee key technical transfer and commercialization projects supported by a key contract manufacturing organization.
- Responsible for establishing and executing project plans, coordinating technical transfer activities, validation, continuous improvement, CMC inputs for regulatory filings and process support for clinical and commercial manufacturing of drug substance and commercial drug product.
Skills and Requirements:
- Bachelor or Master Degree in a scientific discipline
- Strong experience in the field of biologics, vaccines or sterile products.
- Experience in manufacturing, quality and/or tech transfer of biologics/vaccines drug substance and aseptic drug product would be preferred.
- Excellent knowledge of cGMP manufacturing and well versed in regulatory requirements in Europe, U.S. and Japan.
- Demonstrated performance in leading and developing multi-discipline teams.
- Prior work experience of working in Asia is desirable.
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
- Diplomatic, able to navigate across multiple internal and external stakeholders to achieve objectives.
- Demonstrated proficiency in competency areas of Strategic Agility, Organizational Agility, Business Acumen, Process Design and Management, Organization Change Management and Process Effectiveness - in globally diverse, rapidly changing cross-cultural environment.
- If the incumbent is based in Switzerland, frequent travel to Asia will be required, up to 40%
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.