Process Development Manager

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Job Description

Key Roles/Responsibilities:

• Develop products from early concept through to registration for marketing approval.
• Supervision of Development staff in delivery of project work and maintaining the GMP status of the manufacturing activities and systems
• Building and working with a network of external connections to promote our work within the Biopharmaceutical Industry and Academia and to establish our credibility through delivery of external presentations and meetings with potential partners, in-licensing companies and academia
• Leading teams to deliver process characterisation and process validation studies and ensuring the data and reports are suitable for regulatory filings
• Reviewing technical data from clinical production batches as part of the ongoing product development activity to support Regulatory Filings
• Provide technical expertise to assist in trouble shooting issues during technical transfer or routine production.
• 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.
• Coach and develop staff and manage resources
• Risk Assessment of new products/processes to ensure personnel safety compliance with Company requirements for Health and Safety and development expectations
• Management Resources and budget to meet project timelines
• Drive Customer Centricity within Development team
• Project Management
• Manage department budget
• FTE Utilization vs projects
• Liaison with support groups (analytical development, purchasing, Production PDS-QC & QA)

People:

• Coaches and develops 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 competences and demonstrate excellence in the development of biotechnology products.
• The recruitment of staff within the group. Sets objectives for the group and ensures all team members have individual targets for the year. Provides feedback on performance of direct reports regularly throughout the year and ensures direct reports give timely feedback to their reports.
• Devising 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 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 co-ordinate 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