Piramal Pharma is seeking a highly skilled and motivated Process Development Manager to join our dynamic team. In this pivotal role, you will be responsible for leading the development and optimisation of pharmaceutical processes, ensuring the successful transition from laboratory to commercial scale. You will collaborate closely with cross-functional teams, including R&D, manufacturing, and quality assurance, to drive innovation and enhance product quality.
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.