Manager Scientist Upstream Process Development - Vaccine
Company: Principia Biopharma Inc.
Posted on: May 3, 2021
General Description of Department:
The Upstream Process Development Group, as a part of Process
Development Department, has responsibilities to support the
development and continuous improvement of bioprocess production for
manufacturing Flublok influenza and COVID-19 vaccines. It
encompasses the development of production processes (Batch and
Fed-Batch) for seasonal strain changes, evaluation and improvements
of process parameters. Development of the process is strongly
dependent upon the process analytics. Stronger the process
analytical support better the process. The Upstream group provides
also support to other departments such as MFG as needed. We are
looking for an Manager Scientist to provide process support to the
USP team for the Flublok and COVID production processes.
JOB OVERVIEW/KEY RESPONSIBILTIES*:
One of the primary responsibility will be to manage equipment,
sample analysis by different assays, analyze the data and share
with the USP teams. For example analysis of the spent media to
determine the amino acid spent rate using Rebel Amino Acid
Analyzer; and its impact on the yield and productivity. Along the
same lines, metabolic analysis of the cell culture will help in
optimizing the yield. In addition, our Baculovirus Expression
System Technology (BEST) requires generation of WVB. The quality of
the working virus bank is critical for the performance of the WVB
for the production of the target protein. Therefore, analysis of
the WVB at different passages using Pulse Field Gradient
Electrophoresis (PFGE) is to serve as the primary screen to
eliminate unstable WVB. We may perform the deep sequencing of the
unstable WVBs in collaboration with the network to identify regions
that are hot spots for insertions or deletions that may impact the
stability of the WVBs. This information can be used to develop
markers for determining the stability of the WVB. Designing
relevant assays will be the responsibility of the scientist. In
addition, we evaluate the genetic stability of the WVB by RFLP
analysis of the DNA derived from the different passage of the WVB
using Femto DNA analyzer.
In addition, the Scientist will also be responsible for the
execution of experiments in upstream activities through SOPs and
documented protocols. Primary responsibilities will be to compile
and analyze experimental data for biochemical parameters from
BioNova, spent rate for the amino acids using the Rebel system, and
RFLP analysis of the DNA from WVBs and also ECVs that are used for
the generation of WVB and maintaining a database. Knowledge and
experience in process modelling is a huge plus. Duties will include
but not limited to operation and maintenance of bioreactors through
execution of SOPs and protocols, data mining and analysis. Tertiary
responsibilities will be to assist in basic laboratory analytical
Provide process support to the USP team such as analysis of the
metabolic profiles from Bio Nova, complete spent media analysis for
amino acids, vitamins and trace elements, RFLP analysis of the WVB
genetic stability at different passages.
Perform studies to determine the expression level of the protein
of interest in the bioreactor using assays such as ELISA, Octet,
Lentil Lectin affinity chromatography, etc.
Create and Maintain a data base for the data generated under
various conditions and perform trending analysis to compare the
Perform small scale experiments as needed for the protein
production and analysis
Responsible for the smooth functioning of the critical and
important equipment such as Rebel, Fento etc..
Records process development activities and results in PD
notebooks and spreadsheets.
Maintains laboratory notebook documentation in accordance with
PD department rules.
Participates in the cleaning and maintenance of the bioreactor
Assist in updating and maintaining the schedule.
- Key Responsibilities may differ among employees with the same
job title and may change over time, in accordance with business
MS or Ph.D. in Biology, Chemistry, Biochemistry, Chemical
Engineering, or a related field
5-8 years of experience with MS, 2-5 years of experience with
Experience in managing Scientists and Associates
- Excellent writing and presentations skills
Experience in cell culture procedures and associated aseptic
Experience in process development and process scale-up.
Knowledge and experience in performing amino acid analysis of
the spent media, RFLP analysis using DNA analyzer, UPLC/HPLC
analysis and biochemical assays such as ELISA/Octet.
Understanding of cellular metabolism.
Hands-on experience with bioreactors and recombinant protein
production is strongly desired.
General laboratory skills, and experience in process controls
will be highly desirable.
Fluent in both written and spoken English.
Experiences in the Biotechnology and pharmaceutical industry is
Able to work effectively in a collaborative team and to
- Strong verbal and written communication skills.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
Keywords: Principia Biopharma Inc., Meriden , Manager Scientist Upstream Process Development - Vaccine, Other , Meriden, Connecticut
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