Associate Principal Scientist
Associate Principal Scientist - Manufacturing Science And Technology (MSAT) - USP
Be part of something life-changing.
Lonza Manufacturing Science And Technology (MSAT). The beating heart of a living business.
Lonza’s MSAT organization is the beating heart of our business.
We’re a team of experienced and passionate individuals who use ground-breaking solutions to redefine perspectives. We focus on innovation to evolve the link between Lonza and the lives we save. If you’d like to work in a hugely varied role in an exciting area of our growing business, then progress your career as an MSAT Scientist or Engineer.
MSAT plays a critical role in the successful transition of innovative technology and biologics process technical transfer oversight from laboratory to cGMP manufacturing scales providing our customers with range of services in the realization of the next generation of therapeutic molecules with one mission “making tomorrows medicines today”!
The technical diversity, strong teamwork and cross functional collaboration in a fast paced working environment makes the MSAT roles dynamic, exciting and rewarding offering excellent personal and professional development within the function and across the Lonza global network.
We are looking for an Associate Principal Scientist with experience in USP to join the MSAT organization in order to support the technical transfer of manufacturing processes.
This customer-facing role will be to provide technical leadership and decision making via project teams to define the required technical transfer details and oversee the associated GMP documentation in collaboration with external customers as well as other internal cross-functional team members to provide oversight through to a robust cGMP scale process.
- To represent MSAT within multiple customer product project teams using a standard technical transfer process to successfully transfer both defined and/or complex processes either into Upstream Process or Down Stream operations from process development through to GMP manufacturing either in the Lonza Slough site or to other facilities in the global Lonza mammalian manufacturing network
- To be accountable for the identification and introduction of new raw materials for pilot and production scale batches
- To be accountable for assessment and management of technical (process) risks associated with process transfer working closely with operations and Quality Assurance
- To work cross functionally to ensure all relevant critical process and technical information is communicated and shared via projects teams to the required deadlines/ customer requirements
- To actively work collaboratively with the customer technical representatives via face to face and telecom meetings
- To be accountable for on plant technical support of GMP operations
- To contribute to the resolution of identified manufacturing process issues through leading root cause analysis (RCA) procedures to ensure continuos improvements are made to the GMP process
- Support the Quality Systems on a day to day basis on deviation invetigations, completion of correction action plans (CAPA’s) and change controls
- To work with the Subject Matter Experts (SME’s) to develop knowledge base and deeper process understanding and also support as needed junior level team members on specific technical problem resolution
- To proactively anticipate and evaluate technical challenges within area of expertise ie. Upstream or Downstream operations
What we need you to have:
- BSc/MSc or PhD in science related disciplines
- Mammalian and/or biologics background essential
- Proven experience in a cGMP manufacturing environment
- Strong knowledge in process development and/or a manufacturing operations background.
- Be a recognized expert in field USP drug substance operations preferably from working in a cGMP environment.
- Have a successful technical transfer expertise gained from a drug substance-manufacturing environment.
- Have demonstrable experience working in cross functional project management and technical transfer activities with ability to multi task, prioritize and be an effective decision maker.
- Have a deep understanding of biologics manufacturing process as a whole.
- Strong interpersonal skills are required with ability to work cross functionally with internal and external customers.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.