Job Description
Our client is a highly profitable fast growing multinational biologics manufacturer based in the greater Dublin area. The company seek to make an executive appointment to head up operationalising biologics operations within this site.
The newly appointed Site Lead will be responsible for all site operations in support of commercial drug substance manufacturing. The Site Lead will have overall responsibility for delivery supply to customers according to agreed S&OP supply plans and KPIs.
Site activities are inclusive of: plant technical support, manufacturing systems, engineering support, validation execution, technical transfer receiving, manufacturing operations support functions & all direct (in site) functional support. The lead will have end to end responsibility for all production activities, full site budget control, and direct management of multi-functional teams. This will include accountability for performance management/KPIs, OE implementation, financial management, collaboration with key stakeholder functions within and outside of Tech Ops.
Scope will include: start-up of the drug substance manufacturing site targeting the manufacture of 3 commercial products and 1 late stage clinical program. This is a leadership role that will need to balance strategic executive management with the ability to jump in and get to root issues to lead by example.
Additionally the scope will require both strong people management & leadership, and strong, comprehensive technical expertise. This is a very high impact role due to the critical nature of the products that are produced within Site, and the need to ensure 100% patient supply continuity.
Responsibilities of Site Lead Biologics:
Leading & implementing the new Tech Ops operating model, culture & performance expectations. Build & develop strong multi-functional team to drive operations & supply performance to meet key targets
Deliver results of production performance, financial metrics, and compliance to meet quality expectations and supply plans for all plant & warehouse operations. Develop strong partnerships with customers and other stakeholders
Drive establishment of highly effective technical capabilities across all operations and teams, with clear focus on shop floor support & above floor technical support
Manage and improve operations efficiency and effectiveness, deploying Tech Ops OE model and tools to drive impactful continuous improvement
Lead and coach direct team & drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating expectation.
Requirements for Site Lead Biologics:
Bachelor Degree in Science or Engineering, & MBA or Master's Degree.
15+ years relevant biologics manufacturing leadership and management experience.
In depth technical knowledge of biologic manufacturing operations.
Previous leadership experience with matrix cross-functional groups.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Experience operating a multi-product manufacturing plant.
Financial management exposure, awareness, and strong acumen.
Ability to balance strategic awareness & direction setting with consistent tactical results.
Previous direct management of multiple functions.
Technical Requirements for Site Lead Biologics:
Strong biologics manufacturing experience (Drug Substance, Drug Product, strong exposure to biologics process development), technical understanding of multiple biologics platforms, and excellent people management expertise (Leadership & Coaching).
General Technical Operations experience including clinical development, commercialization supply operations, regulatory and compliance experience, hands on technical transfer experience, direct plant management, and exposure across all Technical Operations functions.
Competencies of Site Lead Biologics:
Significant influencing, negotiation, problem solving and decision making.
Translate multiple demands, trouble shoot quickly & effectively, & develop comprehensive plans that will satisfy business needs, multi-functional demands, and most importantly patient supplies.
Ability to rapidly understand complex business & technical issues & multi-option scenarios to build effective plans to mitigate risk & ensure continuity of supply, as well as strategic initiatives.
Other job requirements:
Biologics, Biopharmaceutical operations, process development, clinical development, technical transfer, qualification and commissioning, global regulatory inspections & compliance including FDA & EMA, general management, plant management, CMC & regulatory experience, executive managerial skills.
For further details, please contact; Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie/
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