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Head of Technical (Manufacturing, Packaging), Hertford
Client: Cpl Life Sciences
Location: Hertford, United Kingdom
Job Category: Manufacturing
EU work permit required: Yes
Job Reference: af4290da6c63
Job Views: 6
Posted: 23.01.2025
Expiry Date: 09.03.2025
Job Description:
Overview
Our client, a leading Pharmaceutical manufacturer, is looking to appoint a Head of Technical who will take responsibility for the reliable, efficient, and compliant operation of the Technical Department (Technical Manufacturing, Technical Packaging, and Artwork), ensuring routine GMP compliance and efficient operation.
Provide Subject Matter (SME) Expertise in Technology: The position holder will ensure a scientific approach is taken in the development and change management of packaging materials, product formulation/manufacture/packaging, and cleaning.
Technical Operational Effectiveness: To provide oversight and direction on initiatives that guarantee effective artwork, packaging & manufacturing operations, e.g., Packaging & Manufacturing Batch Record generation, Supplier Management (selection, complaints, etc., but excluding purchasing), determining scale of manufacture and campaign strategies, monitor process variables and determine control measures.
Operational Leadership: To work with the operational leadership team to ensure a safe, compliant, efficient, and cost-effective production operation.
EDCS Effectiveness: Providing guidance, expertise, and support for the strategic technology interface between EDCS Sites, Pharmaceutical Science Technology (PST), Third Party Operations (TPO), and Core Functional Units (CFU) during the development, registration, and introduction of pharmaceutical products to ensure effective supply of existing products and successful execution of product launches. Ensure processes are aligned to global expectations.
General Responsibilities (Safety, Quality, Customer, Cost and Innovations)
* A safe working environment is maintained for self and other employees, ensuring all near-miss incidents and accidents are reported in accordance with procedures.
* The Quality of products manufactured and released is assured through adherence to all procedures.
* Opportunities to improve operations and reduce costs are identified and progressed through continuous improvement and demand innovation initiatives.
* All stakeholder and customer expectations are understood and met through communication.
* Performance is in line with personal and organizational objectives with demonstrated behaviors and competencies.
This position has working relationships with:
* Other Operational Leadership Team (OLT) members to manage operations efficiently and collaboratively.
* The Production Director and the Senior Leadership Team (SLT) in the development and delivery of long-term strategic capital and headcount plans.
* Pharmaceutical Science Technology (PST) Group, Product Champions (PC), and 3rd Party Operations (TPO) during development, registration, and introduction of pharmaceutical products globally.
* Project Sponsors & Stakeholders to ensure project objectives are achieved.
* Regulatory bodies to support submissions and generation of filing documents.
* External parties/suppliers to support all relevant areas.
* Management and staff to ensure a multi-discipline approach to problem-solving, continuous improvement, and project delivery.
* The global manufacturing network (Japan, USA, and regional 3rd Party Operations) to establish global procedures and support tech transfers.
Departmental Management:
* Responsible for compliance with Health and Safety procedures in areas of responsibility.
* Responsible for compliance with Good Manufacturing Practices in areas of responsibility.
* Key player in internal, customer, and regulatory audits.
* Ensure approved technical standard operating procedures (SOPs) are implemented.
* Ensure that required initial and continuing training of departmental personnel is carried out.
* Responsible for regular 1-1 meetings, coaching, and review of development opportunities of all direct reports.
* Develop departmental budget (1 year) and headcount (2-5 year) business plans and manage departmental expenditure.
Provide Subject Matter (SME) Expertise in Packaging, Material Science & Product Formulation:
* Development of the Technical capability of the Manufacturing & Packaging teams through technical leadership and mentoring.
* Plan and execute artwork development, changes, and approval in accordance with registered requirements.
* Planning and execution of process development and confirmation batches.
* Support business development and commercial projects.
* Define and lead development and execution of Process validation studies.
* Define and lead Site Cleaning Validation procedures in Manufacturing and Packaging.
* Define and manage packaging and product material changes.
* Write, review, and contribute to module 3 regulatory filings for manufacturing process development and validation.
Operational Effectiveness:
* Work cross-functionally with the operational leadership team to lead the manufacturing and packaging operation.
* Identify quality-related trends and facilitate the implementation of corrective actions.
* Creation and change management of Packaging & Manufacturing Batch Records.
* Responsible for the management of manufacturing/packaging technical activities.
* Contribute to the definition and delivery of Quality Risk Assessments.
* Support Supplier Relationship Management and issue resolution arising from technical and quality performance.
Skills and Qualifications
* Experience in leading and managing a team.
* Experience in the pharmaceutical industry.
* Applicable science-based degree.
* Applicable technical knowledge and good technical writing ability.
Competencies
* Strong at motivating and leading a team.
* Coaches and develops direct reports and others in the team.
* Professional behavior, self-aware, and can build great team culture.
* Excellent communicator who can flex styles for differing target audiences.
* Can problem solve and remain calm under pressure.
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