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Job Description
Key Roles/Responsibilities:
1. Develop products from early concept through to registration for marketing approval.
2. Supervise Development staff in delivery of project work and maintaining the GMP status of the manufacturing activities and systems.
3. Build and work with a network of external connections to promote our work within the Biopharmaceutical Industry and Academia and establish our credibility through delivery of external presentations and meetings with potential partners, in-licensing companies, and academia.
4. Lead teams to deliver process characterisation and process validation studies, ensuring the data and reports are suitable for regulatory filings.
5. Review technical data from clinical production batches as part of the ongoing product development activity to support Regulatory Filings.
6. Provide technical expertise to assist in troubleshooting issues during technical transfer or routine production.
7. Ensure reports, documents, and CMC regulatory sections are prepared to cover the development of the product and process and can be included in Regulatory Filings for biologics products.
8. Coach and develop staff and manage resources.
9. Conduct Risk Assessments of new products/processes to ensure personnel safety compliance with Company requirements for Health and Safety and development expectations.
10. Manage resources and budget to meet project timelines.
11. Drive Customer Centricity within the Development team.
12. Project Management.
13. Manage department budget.
14. FTE Utilization vs projects.
15. Liaison with support groups (analytical development, purchasing, Production PDS-QC & QA).
People:
1. Coach and develop staff to meet individual professional development needs and business needs, building an effective team through continued development to ensure they are equipped with scientific and technical competencies and demonstrate excellence in the development of biotechnology products.
2. Recruit staff within the group, set objectives for the group, and ensure all team members have individual targets for the year. Provide feedback on performance of direct reports regularly throughout the year and ensure direct reports give timely feedback to their reports.
3. Devise the training and development plan for the group.
Qualifications
Essential Qualifications:
Degree in relevant subject (Pharmacy, Biochemistry) or equivalent.
Essential Experience:
Bachelor of Science or higher (ideally PhD) and significant experience in leading process development projects within the biotechnology industry is required.
Experienced people manager, with a track record in effectively resourcing, scheduling, and delivering development programmes through teams. Demonstrated competency in building effective teams and setting goals, measuring performance, coaching, and developing staff.
A wide knowledge of pharmaceutical manufacturing processes, and the ability to coordinate a number of projects from initiation through to completion.
A wide knowledge of GMP and Health and Safety requirements, in particular for clinical supplies manufacture.
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