Upstream MSAT Scientist I

Lonza•Portsmouth, NH

8d•Onsite

About The Position

This position is responsible for being the primary technical Upstream MSAT support person for manufacturing processes. Preferably, this person has prior experience with manufacturing processes and/or technical transfer. The individual falls under supervision of area leader but is expected to have a good grasp of key aspects of the role, and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

Requirements

Bachelor's degree in Biotechnology, Biological Sciences, or Chemical Engineering
1+ year of biotech experience (or equivalent with advanced degrees)
Experience in commercial manufacturing and GMP regulations
Strong communication and technical writing skills
Proficiency in data analysis and problem-solving
Knowledge of cell culture and process development
Willingness to provide 24/7 on-call support during manufacturing

Nice To Haves

Prior experience with manufacturing processes and/or technical transfer.

Responsibilities

Perform a majority of functions associated with upstream process transfer and/or process support.
Recommend improvements for MSAT practices and procedures.
Assess minor deviations and assess product quality impacting deviations with assistance.
Identifies potential Root causes using a systematic approach.
Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.
Performs and is able to understand and interpret higher level data analysis.
Authors and reviews process documents.
Able to identify and create new documents that would aid in process transfer or support activities.
Identifies process changes and assess change controls for impact of process / equipment or procedural changes that can affect both process performance and product quality.
Represents Upstream MSAT on project teams and interfaces with customer technical and quality representatives.
Represents MSAT on internal teams.
Participates in Customer Audits.
Regularly interacts with several functional areas, divisions and/or customers.