Executive Director, Biologics External Manufacturing & Site Lead
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in City of London United Kingdom.
The CompanyOur client is a leading Biotech company.
Role DescriptionExecutive Director, Biologics External Manufacturing & Site Lead
The Executive Director of Biologics External Manufacturing will develop, support and implement a portfolio of contract manufacturing partners (CMO’s) in Europe and Asia, acting as General Manager of an external plant network. The position will:
· Lead a cross-functional team overseeing selection (with Procurement), technical transfer, and commercial supply of biological drug substance and aseptic drug product from CMO’s.
· Establish supplier strategies and relationships in the Europe and Asia Pacific region to assure win/win partnerships and secure product supply requirements in alignment with the company strategy.
Responsibilities- Oversee strategic supplier relationships, manage performance of CMO’s to meet company requirements for commercial biologics manufactured in Europe and Asia. Accountable for assuring compnay contract obligations are met. Manage a portfolio of outsourced projects.
- Plan, source make and deliver biologics, meeting established KPI’s for safety, quality, customer service, cycle time, and financial targets.
- Lead a cross-functional team including supplier relationship managers, supply chain, manufacturing technology, person in plant, and manage matrix relationships with quality, regulatory, manufacturing, procurement, and other matrix partners.
- Oversee key technical transfer and commercialisation projects supported by CMO’s. Responsible for setting strategies and implementing plans related to CMO selection, defining technical transfer activities, process fit, validation, continuous improvement, CMC inputs for regulatory filings and process support for clinical and commercial manufacturing of drug substance and commercial drug product.
- Responsible to align and maintain collaborative partnerships with internal and external cross functional teams that support contract manufacturing.
- Establish organisational plans; recruit and develop talent.
- Establish and meet budgets, inventory and financial targets.
Requirements- Minimum B.S. in scientific discipline; cell culture, protein chemistry, biochemistry, biochemical engineering, or other related disciplines.
- Advanced degree (Masters, PhD, MBA) strongly preferred
- Certification in APICs, Project Management or Operational Excellence desired.
- Extensive experience in manufacturing, technical transfer and commercialisation of biologics, vaccines, sterile products. Preferred candidate will have experience in manufacturing of biologics/vaccines drug substance and aseptic drug product. Demonstrated capability
- Multi-disciplinary experience including: manufacturing, supply chain, manufacturing technology and quality, technical transfer, project management.
- Knowledge of cGMP manufacturing and well versed in regulatory requirements in Europe, U.S. and Asia.
- Experience in leading a team successfully in manufacturing troubleshooting and problem solving.
- Demonstrated performance in leading and developing multi-discipline teams.
- Experience in managing complex projects, and driving operational excellence. Knowledgeable in Lean/Six Sigma principles with a track record of innovation and continuous improvement.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.