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Manager Scientist Upstream Process Development - Vaccine

Company: Principia Biopharma Inc.
Location: Meriden
Posted on: May 3, 2021

Job Description:

POSITION OVERVIEW

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 techniques.

Responsibilities include:

  • 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 experimental conditions,

  • 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 room

  • 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 needs.

BASIC QUALIFICATIONS:

  • 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 Ph.D.

  • Experience in managing Scientists and Associates

  • Excellent writing and presentations skills

PREFFERED QUALIFICATIONS:

  • Experience in cell culture procedures and associated aseptic techniques.

  • 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 a plus.

  • Able to work effectively in a collaborative team and to prioritize assignments.

  • 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.

#GD-SP

#LI-SP

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 all.

Keywords: Principia Biopharma Inc., Meriden , Manager Scientist Upstream Process Development - Vaccine, Other , Meriden, Connecticut

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