Senior Manager, Downstream Manufacturing - Ireland
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Company’s Commercial organization supports our global sales and marketing efforts around the world.
- Our global sales force continues to solidify the company’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific.
- Come join our team and make a meaningful impact on patients’ lives.
- Reporting to the Manufacturing Director, the primary role of the Purification Senior Manager is to lead the downstream team through successful product launch activities, process validation and HPRA/FDA approvals.
- It is expected the Purification Senior Manager will lead in a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant manufacture of Drug Substance material.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
- Manage group of process engineers & biotechnicians through construction projects, C&Q, technical transfer activities, process validation and site regulatory inspections as part of the manufacturing operations.
- Lead and support the downstream team in the purification of drug substance material under cGMP conditions.
- Develop and lead the downstream team in areas of technical expertise, embed the use of Business Process Engineering tools, and coach and mentor high performance team behaviours.
- Participate in budget planning and headcount planning.
- Communicate capital equipment needs, facility needs, team needs; and contract service requirements
- Influence, support and partner closely with the Cell Culture Lead, process engineers, Biotechnicians and other colleagues to ensure master batch records, SOPs and other documents are generated, current and compliant under cGMP conditions – ensure manufacturing systems and practices are consistent throughout the organization.
- Lead, coach and support daily operation of downstream processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Embed the use of six sigma and lean manufacturing practices leading to operational excellence.
- Represent Manufacturing team as necessary at critical meetings including tech transfer, quality and project meetings.
- Develop and demonstrate a proactive approach to safety, industrial hygiene, environmental and regulatory compliance
- Participate and support plant optimization that helps create a strong value proposition for future investment.
- Lead and demonstrate strong stakeholder management in terms of interfacing with other company departments (Regulatory Affairs, Quality control, Quality Assurance, Facilities, etc.) and contractors as necessary.
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering and / or a minimum requirement of 10 years industry experience in a related field or equivalent experience is preferred.
- Demonstrated experience working with protein purification processes in a manufacturing environment, including specific experience in chromatography, ultra-filtration, and other unit operations.
- Past experience and demonstrated ability to successfully influence team performance is strongly preferred.
- Strong demonstrated ability in the area of communication and strong ability to interact within cross-functional teams.
- Demonstrated ability coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections and direct interaction with regulatory inspectors.
- Highly developed organizational and leadership skills.
- Process development and/or technology transfer experience preferred.
- Track record of embedding a strong Quality culture. Trackwise experience preferred.
Should be proficient in the operation of all equipment used in Purification processes including chromatography, ultrafiltration, viral inactivation & filtration, & bulk filling
Work closely with Process Development, Manufacturing Science and Technology, Quality Operations, Facility Services, Manufacturing, Warehouse and Supply Chain personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
The downstream senior manager will typically lead 20-25 direct reports including process engineers, bioprocess specialists and biotechnicians working on a shift rotation.
- This description is not intended to be all-inclusive or a limitation of the duties of the position.
- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.