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Technical Operations, Associate Director
4 weeks ago
Overview
Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and drug pipeline.
With a passion for best practice in every aspect of its business, this well-managed, high performing company has a motivated workforce who are passionate about operational excellence.
Job Title:
Technical Operations, Associate Director
Role context:
The role operates a model of excellence through partnership via the virtual plant in a dynamic and flexible environment, ensuring end-to-end integrity of the commercial supply network to deliver quality medicines to patients safely, efficiently and with value, while fostering diversity, inclusion and belonging.
Responsibilities
Build and maintain influential relationships with internal and external stakeholders, providing technical leadership and packaging engineering expertise to external supply teams to support management of CMOs in the supply network.
Provide technical input and guidance on drug product and packaging CMO vendor selections and technology transfers, collaborating with Pharmaceutical Development to ensure network capabilities for tech transfer to CMOs as needed.
Lead implementation of new technology or upgrade projects at external CMO packaging sites with internal and external stakeholders.
Provide technical input and operational support during packaging IQ/OQ/PQ and PPQ qualification studies led by CMO Validation/External Quality.
Contribute technical input for primary and secondary packaging development and shipping development studies to support new product introduction.
Provide technical oversight at CMOs for Packaging Engineering trials related to new product introduction, changes to packaging components/processes, or internal changes, ensuring controls are documented in SOPs or Batch records and continually updated.
Ensure Design Control is maintained for secondary packaging of commercial devices via design control documents, change controls, and verification activities with CMOs.
Maintain Packaging Control Strategy as a lifecycle document and identify critical parameters for all packaging processes.
Provide technical input and leadership support to drug product processes (solid oral, vial, syringe filling), troubleshooting and continuous improvement with key stakeholders.
Contribute to regulatory filings and CMC as required.
Provide technical leadership into drug product and packaging investigations with CMOs and cross-functional support teams to ensure root cause is identified and sustainable CAPAs are in place.
Responsible for day-to-day process operations conducted by CMOs; act as process owner for manufacturing processes and ensure efficient operation to supply products to patients.
Work with network suppliers (internal and external) to publish KPIs focused on delivering efficient processes.
Apply latest engineering techniques to reduce time to market while meeting regulatory requirements, deadlines and costs; collaborate with other departments to meet production, quality and safety targets and drive improvements to reduce customer complaints.
Identify and mitigate risk through active participation in risk management processes.
Maintain and develop packaging competency library for current and future product strategies.
Collaborate with PharmDev to develop new drug products and packaging designs suitable for commercial operations across the network.
Provide technical expertise in drug product manufacturing operations including process development and troubleshooting; input to future site/process selections for new products.
Qualifications
Engineering or Science Qualification (Bachelor's/Master's preferred) with significant drug product and packaging engineering experience in high-volume pharmaceutical/healthcare packaging; experience with new product/process introductions in accordance with EHS and cGMP standards.
Experience in a cGMP environment with strong discipline in change control and risk assessment to evaluate processes and implement improvements.
Proven problem-solving abilities with ability to identify facts, consider alternatives and close investigations and CAPAs in a timely manner.
In-depth knowledge of primary and secondary packaging for pharmaceutical products with understanding of global regulatory requirements related to design and control.
Drug product operations experience in oral solid dosage, vial and syringe filling.
Strong mechanical capability with hands-on experience with equipment; experience in a technical role within high-volume manufacturing preferred.
Ability to read and interpret complex engineering drawings and understand geometric dimensioning and tolerancing as it relates to packaging design.
Ability to quickly understand new technologies, grasp operating principles and troubleshoot with technical teams.
Excellent verbal and written communications, including technical reports and investigations, with strong presentation and influencing skills.
Approximately 20% domestic/international travel expected.
Contact:
Cv to
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Pharmaceutical Manufacturing
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