This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.
Job Description
Key Roles/Responsibilities:
1. Subject Matter Expertise and Siting Resolution: Provide expert guidance on manufacturing process scale-up activities, contributing to the resolution of siting issues to ensure efficient production operations.
2. ADC Product Transition Oversight: Supervise the seamless transition of client ADC products into manufacturing suites, collaborating with cross-functional teams to mitigate siting challenges and uphold production timelines.
3. Collaborative Process Development Support: Collaborate with MSAT, PD, and BD teams to facilitate early-stage process development and manufacturing, guiding projects towards successful transfer to GMP Manufacture.
4. Refinement of GMP Processes: Engage with MSAT during the siting stage to optimize processes for GMP manufacturing, ensuring compliance and efficiency in a regulated environment.
5. Lean Material Requirement Oversight: Partner with MSAT during siting to streamline material requirements, enhancing efficiency and minimizing resource utilization in GMP manufacturing settings.
6. Manufacturing Representation at Events: Serve as the manufacturing Subject Matter Expert (SME) to support BD at relevant commercial events and trade shows, showcasing manufacturing capabilities and fostering business relationships.
7. Equipment Design Phase Involvement: Participate in the design phase of equipment requirements for new manufacturing and scale-up projects, ensuring alignment with production needs and objectives.
8. Qualification Document Review: Act as the manufacturing point of contact for the review of qualification documents for new projects and scale-ups, ensuring adherence to regulatory standards and company protocols.
9. Next-Generation Equipment Implementation Support: Support the implementation of next-generation equipment to drive innovation, providing training and documentation to optimize utilization and enhance operational capabilities.
10. Self-Motivated Leadership and Deputization: Demonstrate self-motivation and initiative, working effectively under pressure and autonomously. Deputize for the Operations Director in their absence, contributing to strategic leadership decisions on the Senior Leadership Team (SLT).
11. Audit Preparedness Coaching: Serve as the primary point of contact to coach production managers in audit preparedness and execution, ensuring compliance with regulatory requirements and industry standards.
12. Strategic Oversight: Provide strategic leadership and direction for the Piramal Grangemouth Production Support department, aligning activities with business objectives and ensuring the efficient operation of all departmental functions.
13. Siting Transition Management: Oversee the smooth transition of client ADC products into the ADC manufacturing suites, coordinating with cross-functional teams to address any siting issues and minimize disruptions to production schedules.
14. Resource Optimization: Effectively utilize the resources and experience of the Production Support team to ensure timely documentation and action approval, facilitating the commencement of manufacturing for repeat clinical and commercial products. Implement efficient workflows and processes to streamline operations.
15. Manufacturing Support: Provide support and guidance to the manufacturing team during ongoing ADC batch manufacture, assisting in the resolution of any deviations from established processes. Collaborate with relevant stakeholders to implement corrective actions and optimize production efficiency.
Qualifications
Essential Qualifications: Minimum BSc Hons in Chemistry or scientific degree
Essential Experience:
* 5 years plus experience of working in ADC manufacturing
* Excellent working knowledge of GMP
* Excellent understanding of bioprocessing manufacturing processes and equipment
* Experience of implementing change using change control principles.
* Excellent verbal and written communication skills
* Strong organization skills
* Good Leadership skills
About Us
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
#J-18808-Ljbffr