ProClinical is currently working with a leading global pharmaceutical organisation, that is seeking to hire a Production Lead, External Manufacturing. The Production Lead, External Manufacturing manages manufacturing operations with defined scope at CMOs and/or within a CMO site. Responsibilities include commercial and/or clinical supply and tech transfer activities, and providing support to relationship managers within International External Manufacturing.
- Primary contact and relationship manager to specified CMOs for a single product or for the entire relationship depending on the size and tier of the supplier. This includes managing site performance to BIIB expectations with specific KPIs.
- May lead matrix teams, to drive projects both internally and externally as it relates to the relevant API, DP, and FG operations. These projects can include activities like Technology Transfers, process optimizations, validation activities, packaging changes, and the associated change management and project management.
- Monitoring and evaluation of CMO key deliveries and performance. Follow up on KPI's and ensures the CMOs constantly meets standards and expectations for contract obligations, compliance, quality, and production performance and that performance is documented.
- Responsible for aligning with the internal planning teams to ensure production schedules are maintained with the relevant CMO or supplier.
Skills and Requirements:
- Experience in biotech/pharmaceutical cGMP manufacturing industry with supplier relationship experience.
- Experience with either biologics or solids manufacturing including a mix of parenteral filling, API and solids manufacturing and, finished goods production.
- Demonstrated project leadership skills and ability to develop effective working relationships with internal/external partners and cross-functional project teams.
- Excellent communication skills both verbal and written. Ability to communicate at different levels of the organization.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.