Our client, one of the top Global Pharmaceutical companies are seeking a Director level candidate to join as Biologics External Manufacturing Operations and Supplier Relationship Manager.
The Director is to be the lead Operations person, responsible for the delivery of outsourced key strategic manufacturing and tech transfer initiatives at a key contract manufacturing organization, including project planning, coordination and external manufacturing oversight. Leveraging local and global company resources through collaborative working, this position is responsible for monitoring of vendor activities and establishing/tracking metrics as applicable.
There will be regular travel to supplier facilities in Asia.
- To oversee strategic supplier relationship with a key contract manufacturing organization, managing performance of CMO to meet company requirements for commercial biologics manufactured on site. Responsible for assuring company contract obligations are met.
- To lead a matrixed team managing daily business at a key contract manufacturing organization, including, but not limited to: Ensuring timely document reviews and approvals, driving change controls and deviations to closure and managing customer requests.
- 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 monitors vendor performance and proactively identified issues and risk with their operations. Where necessary, escalates issues and risks to the project technical teams.
- To coordinate review and acceptance of vendor deliverables and approves vendor invoices for payment.
- 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.
- To actively manage product and raw material/consumable obsolescence as well as to act as a key project team interface back to the BEM organization.
Education, Skills and Experience
- Bachelor or Master Degree in a scientific discipline is required.
- Minimum 10 years of 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.
- Fluency in the Korean language is an advantage (but not essential) as is prior experience of working in Asia. Fluency in English is a must.
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
- Strong ability in negotiating and influencing without authority in complex, high impact situations.
- 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.
- Demonstrated ability in technical writing, computer knowledge and communication skills is required.
- Strong presentation and communication skills both, oral and written.
- 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 Will Hitchcock on +44 203 0789 554 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.