Lead Principal Scientist - MSAT (Manufacturing, Science and Technology)

Lonza - United States3.6

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision:
We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary
Lead Principal Scientist – MSAT (Manufacturing, Science and Technology)

Be part of something life changing.

Lonza MSAT. The beating heart of a living business.

Lonza Manufacturing, Science and Technology is the beating heart of our business.

We are 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 would 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.

The role:
Due to the significant growth and expansion of Lonza’s Slough manufacturing operations and Lonza’s global center of excellence in process development, we have a number of open positions for most senior roles as Lead Principal Scientists to join the Manufacturing, Science and Technology (MSAT) organization. These senior technical positions will lead the technical transfer of multiple concurrent complex manufacturing processes (either USP and/or DSP) using their technical expertise and knowledge of Process Development and cGMP manufacturing. The roles are senior within the Lonza global manufacturing network and are accountable to ensure that a robust manufacturing process is devloped, transfered and technically supported according to current GMP requirements and regulatory.

The Lead Principal Scientist will be a recognized subject matter expert in all aspects of USP or DSP technology and manufacturing operations. The individual will provide daily technical leadership to multiple customer facing project teams to oversee the deliver, perform complex technical data analysis and deliver the author complex technical process documentation in collaboration, negotiation and discussion with external regulators, customer technical peers team and internal stakeholders across all opersational functions.

This role will have an established external network and have influence and credibility across all technical functionds and global operations in area of expertise and with site senior management. This indiviual will be expected to represent Lonza scientific integrity at global technical metings and conferences.

To represent MSAT within within multiple customer facing product project teams using a non standard and new methodology/procedures to successfully transfer USP and/or DSP cGMP biologics manufacturing processes in accordance with GMP and regulatory requirements.
To be accountable for the introduction and support of qualification/validation of new process technologies into cGMP manufacturing, whilst managing technical risks associated with any process transfer, leading cross functional teams to ensure relevant transfer and communication of critical process and technical information such that successful outcomes are achieved as agreed with all customers and stakeholders.
To pro-actively communicate effectively negotiate, collaborate and demonstrate technical creability and influence over customer technical peers, via both face to face meeting and telecoms driving problem resolution and offering successful technical compliant outcomes
To be accountable for independent knowledge and expertise of manufacturing technical support, process monitoring, equipment operations analysis of complex data using experience and prior knowledge to anticipate issues before they become critical.
To lead associated compliance activities e.g. process validations, deviations, change controls leading cross-functional teams to successfully plement improvements according to customer and business needs.
To be self-managed in resolving gaps in unit operations through batch reviews and applied continual process learning/knowledge capture facilitating cross functional learning.
To be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
To act as coach/mentor to other scientists across the Lonza global network sharing knowledge in certain aspects of process operations and providing trouble shooting expertise to other manufacturing sites.

What we need you to have:
MSc/PhD in science related disciplines
Mammalian background for monoclonal antibody (drug substance) manufacturing support experience
Extensive experience in a drug substance GMP operations and/or regulatory role with strong knowledge in process development and process validation background.
Be an industry recognized expert in field USP and/or DSP drug substance operations from working in the filed for an extensive period of time.
Have a successful technical transfer expertise gained from a drug substance-manufacturing environment.
Have demonstrable experience working in cross-functional project management with ability to multi task, prioritize and be an effective decision maker influential.
Have a deep understanding of manufacturing process as a whole e.g. Supply chain, analytical, QA, QC.
Strong interpersonal skills are demonstrated leadership experience required with ability to lead internal and external customers on a daily basis.
Applications opening date: 02/01/2019

Applications closign date: 02/02/2019

Salary: Competitive

We look forward to your application!

Lonza. The place to Go, Stay and Grow.