Head of Drug Product Operations

Quotient Sciences; Alnwick; Vor Ort; GBP 120.000 - 170.000; Vollzeit

Zusammenfassung

Quotient Sciences’ Arcinova site in Alnwick seeks a Head of Drug Product to lead Drug Product Manufacturing and Formulation Development.

You will lead and coach teams to deliver customer projects, align with operational strategy, ensure GxP compliance, and drive performance, capacity planning and growth.

Qualifikationen

• Proven leadership of technical staff in pharmaceutical settings.
• Extensive knowledge of GMP formulation development and Drug Product manufacturing.
• Experience working with customers, commercial, finance and compliance teams.
• Strong understanding of GMP/GLP regulations and requirements.
• Excellent written and oral communication skills.
• Flexible and adaptable to new challenges.

Aufgaben

• Lead the Drug Product Operations and Formulation Development teams to deliver customer projects.
• Develop and implement the site's operational strategy and capacity plans.
• Provide technical, scientific and administrative leadership to the DP team; act as Study Director or PI for GLP studies as needed.
• Build and maintain strong customer relationships and drive a one-business, one-experience approach.
• Drive continuous improvements, reporting monthly metrics and ensuring compliance with guidelines and SOPs.
• Work with People, Compliance, EHS, IT and Facilities to meet health, safety, quality and regulatory requirements.

Kenntnisse

Leadership

GMP Formulation

DP Manufacturing

Regulatory Compliance

Stakeholder Management

Communication

Ausbildung

BSc (Hons) in a relevant scientific discipline

Jobbeschreibung

The Role

Arcinova, a Quotient Sciences company, is seeking a Head of Drug Product to lead our Drug Product Manufacturing and Formulation Development teams based at our Alnwick site.

In this role, you will lead, engage, develop and coach teams of manufacturing and formulation scientists to ensure the successful delivery of customer projects. Working closely with global leaders, you will support the delivery of the Drug Product operational strategy and wider business objectives, while developing and maintaining operational capacity plans that underpin future growth and investment decisions.

You will be responsible for ensuring Drug Product operations are conducted in compliance with relevant GxP guidelines and regulations, while driving operational performance, customer satisfaction and commercial success. This is a key leadership position with responsibility for ensuring Quotient delivers the right services to the right customers at the appropriate price, supporting the achievement of the site's financial and strategic objectives.

Main tasks and responsibilities

People and Culture

• Achieve high levels of performance and engagement through inspirational and authentic leadership, coaching and mentoring of the Drug Product Operations team.
• Develop robust talent and succession pipelines to develop and retain key talent and deliver business objectives.
• Ensure adequate recruitment, training and employee development is in place to maintain a highly motivated, skilled and effective workforce, ensuring the needs of the business are met.
• Ensure Quotient's manifesto, behaviors and 'The Quotientness of Quotient' (Science, Agility and Culture) is embedded, lived and evolved.
• Create a collaborative, inclusive and engaging culture where everyone has the opportunity to achieve their potential and develop their career within Quotient.

Strategy Setting and Deployment

• Work closely with Global and Local leaders to deliver Quotient's operational strategy and operational business objectives.
• Develop and deliver the yearly financial target for Drug Product Operations including Revenue, EBITDA and Capital expenditure.
• Stay ahead of market developments, anticipate challenges and adapt business plans appropriately.

Technical Leadership

• Lead the strategic operational projects within DP Operations.
• Provide technical, scientific and administrative support to, and manage a team of scientists engaged in formulation development and Drug Product Manufacture.
• For GLP studies perform the role of Study Director or Principal Investigator.

Customers / Commercial

• Build and maintain strong relationships with customers by developing and implementing integrated operational delivery offerings to ensure Quotient remains competitive in commercial landscape, and ensure first class operational delivery and service.
• Drive harmonization activities to ensure a one business, one experience for customers.
• Engage with Business Development and commercial teams to support new project opportunities and triage appropriately.

Operational Excellence

• Drive continuous improvements throughout Drug Product operations to deliver efficiencies and enhanced compliance standards.
• Develop, maintain and visualize monthly metrics to demonstrate continuous improvement.

Compliance

• Work with the People, Compliance, EHS, IT and Facilities functions to ensure all activities are conducted in line with the necessary health & safety, legal, financial, quality and external guidelines and SOP’s and the site and functional objectives are met.
• Keep abreast of regulatory changes and ensure Quotient processes remain compliant with emerging regulatory needs.
• Support the conduct of client audits and those from regulatory agencies. Bringing wider regulatory/local system knowledge to bear.

Qualifications and experience required for competent performance

• BSc (Hons) or equivalent in a relevant scientific discipline.
• Experienced working with customers, commercial, finance, HR and compliance teams.
• Experienced leader of technical staff.
• Extensive knowledge and experience of pharmaceutical GMP formulation development and Drug Product manufacturing.
• Experience of Steriles manufacture process and procedures.
• Experience of GMP/GLP regulations and requirements.
• Excellent written and oral communication skills.
• Have a flexible approach to new work challenges.