MSAT Scientist III - lonza : Job Details

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Job Description:

Manufacturing Science and Technology (MSAT) Scientist III. As a member of

the MSAT Team, responsible for the successful transfer of viral vector

bioprocesses into GMP production. As such, you are in direct contact with our

clients and internal cross functional teams. Scientist III will ensure successful

process scalability and manufacturability. Scientists in this role are responsible

for all the process integration-related aspects of work during campaign

preparation, process supervision, reporting during and after production

campaigns, leading relevant major deviations and continuing manufacturing

process improvement under the supervision of a Sr. Scientist and/or Manager.

Key Responsibilities:

* This individual will utilize the process flow diagrams, learned expertise, and transferred

data to transfer detailed, step-by-step manufacturing processes under the supervision

of a senior MSAT scientist and/ or manager of MSAT.

* This position has responsibilities that can be exemplified by the technology transfer of

all aspects of buffer and media production, cell thaw and culturing, harvesting,

purification, and/or bulk filling of drug substance.

* This person will perform portions of process transfer from either PD Lonza or from

customers. This individual will do this commensurate with their experience and under

GMP conditions. This person will utilize project and time management skills to ensure

that all tasks will be completed within a timely manner, and that risks to project

execution are raised in a timely manner to senior engineer(s), project management, and

/ or MSAT management as appropriate.

* The position will support new product introductions (NPI/ technology transfers) with

minimized assistance from the senior engineer associated with a project, as well as

ongoing manufacturing runs by correcting errors noted in previous runs, observing

processing on-the-floor (under the supervision of a senior scientist), and overseeing

operations within their area of subject matter knowledge to assure planned, predictable

operations, as well as to correct if the operations are not performing as anticipated by

the manufacturing records.

* The individual gains mastery of various unit operations, the science behind it, and

associated process analysis techniques, and applies them, and continues the journey

from individual contributor to subject matter expert in either upstream or downstream

processing. This individual will pursue successful resolution of complex quality system

deviations from expected results, driving for holistic and/or targeted solutions to ensure

process and product quality and the smooth, on-time delivery of batches to our

clientele, looking for overall improvement in systems and processes each time.

* This position is likely to participate in more complex tasks such as the technology

transfer and oversight, as well as process improvements, for all process steps, under

reduced supervision of the senior MSAT scientist associated with the project.

* This person may assist in the creation of a full bill of materials for a given program,

likely performing materials suitability assessments for appropriate alternatives / second

sources for materials needed in conjunction with a junior engineer who is more likely to

take the greater part of this activity.

Key Qualifications:

* Bachelor's Degree required in a field Related Science

* 5 years of experience

* Advanced knowledge of cellular biology, cell culture, scale up, mass transfer, bioreactor

* operation, and / or depth filtration, tangential flow filtration, chromatography, viral filtration;

* buffer and media production; aseptic processing

* Demonstrates critical thinking skills in problem solving and decision making

* Ability to explain technical problems in terms sufficient for other technically-trained people

* to understand the problem and proposed solutions, both verbally and in writing

* Ability to independently lead small projects and to create, maintain, and utilize the cross-

* functional support of other departments within the asset for the accomplishment of objectives

* Ability to perform basic and advanced root cause analysis techniques for resolving

* deviations and identifying appropriate CAPA: Five why, Kepner-Tregoe, Fishbone,

* Pareto, Scatter plotting, DMAIC for RCA

* Ability to perform basic risk identification and remediation and lead basic and advanced

* risk assessments using standardized methodologies which could include FMA, FMEA,

* HAZOP, and/ or HACCP

* Attention to detail and high level of accuracy

* Some knowledge of statistical data analysis is a plus

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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.