Manufacturing Operations Manager
Posted on Sep 4, 2020 by Real Staffing Group
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its orphan and inflammation groups. Horizon's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
Reporting to the Director of Manufacturing Operations, the Manager Manufacturing operations position is responsible for support & oversight of manufacturing operations of companies commercially marketed products.
This is a role for a professional who has a solid foundation of experience in a biotechnology manufacturing plant. It is a career development opportunity to gain further experience with a wide range of products and technologies as well as collaborating with a set of functions such as Development and Supply Chain.
- Ensures large scale commercial batch processing continuously meets Safety, Identity, Strength, Purity and Quality (SISPQ) requirements
- Work closely with Contact Manufacturing Organisations (CMO's) to drive improvements in manufacturing processes and operations
- Develop effective collaborative working relationships with counterparts within CMOs
- Assesses, approves and oversees implementation of process related change controls and Corrective Actions (CAPA's)
- Provides technical direction to resolve immediate process issues
- Interfaces regularly and builds strong working relationships with other departments, such as Process Development, Quality Assurance, Quality Control, Supply Chain and Project Management
- Reviews, and/or approves Batch records, Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
- Have oversight of CPV programs being developed and review and trend data as required
- Participates in continuous process monitoring to identify areas of focus for continuous improvement and process robustness
- Ensure that the systems internal to the Manufacturing Operations function consistently and meet all cGMP and other regulatory requirements
- Ensures investigations and deviations are managed and closed in a timely manner to meet compliance standards
Qualifications and Skills Required:
- Master's degree in Biochemistry, Pharmacy, Engineering or related field
- 3 years' experience within manufacturing or technical operations in the pharmaceutical (biologics industry). This should be in a manufacturing drug substance process role
- Experience with leading investigations, using investigational tools and QMS systems
- Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) and regulatory compliance/documentation requirements
- Proven track record in identifying opportunity, engaging in cross-functional improvement efforts.
- Ability to support regulatory submissions
- International travel of up to about 2 weeks at a time will periodically be required when circumstances allow
Not sure yet? No CV ready please get in touch for more details? For immediate consideration please apply with an up to date CV.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales