Downstream Process Development Manager - Vaccine

Principia Biopharma Inc. Meriden , CT 06451

Posted 4 weeks ago

POSITION OVERVIEW:

The Downstream Process Development, MTech/ IA department supports several projects including:

  • Seasonal strain changes for Influenza Flublok Vaccine.

  • Process improvement

  • Yield improvement

  • Process monitoring

  • Provides manufacturing support

  • Supports other departments such as Regulatory and Quality.

KEY RESPONSIBILITIES:

  • Primary responsibilities are the execution of development studies such as resin reuse, process improvements, optimization, scale up, column load and evaluation of yield improvement strategies as outlined by the Deputy Director DSP/MTech with minimum supervision in collaboration with others on projects.

  • Executes purification experiments including automated or high-throughput chromatography (AKTA platform), filtration, clarification/ depth filtration, column packing, and tangential flow filtration independently based on expert knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography. Makes detailed observations, analyzes data and interprets results. Exercise technical discretion in the design, execution and interpretation of experiments that contribute to projects.

  • Prepares technical reports, summaries, protocols, and quantitative analyses.

  • Maintains high level of professional expertise through familiarity with scientific literature.

  • Investigates, creates and develops new methods and technologies for project advancement.

  • May participate in scientific conferences and contribute to scientific journals.

  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways and other such duties and responsibilities as may from time to time be reasonably assigned.

  • Responsible for training on, understanding, and following documented procedures which apply to their departments.

  • Responsible for general lab maintenance.

  • Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

LEADERSHIP QUALIFICATIONS:

  • Experience in mentoring junior staff regarding laboratory procedures and scientific projects

  • Perform trouble shooting as required, and supports staff

  • Guides direct reports to optimize productivity, provides continuous development opportunities both personally and professionally

  • Serve as a subject matter expert both inside and outside the company. May act as an advisor to the senior management and assist with the professional development efforts of the team

BASIC QUALIFICATIONS:

  • Ph. D. in Biology, Biomedical, Biotechnology, Biochemistry or similar discipline

  • 3- 5 years of experience (preferably in industry)

  • Process scale chromatography and filtration experience required

  • A proven record of publications in peer reviewed journal. (Documented post-doctoral experience in the form the peer reviewed publications, is preferred).

OTHER SKILLS:

  • Fluent in English both oral and written

  • Good communication and social skills.

  • Excellent team member

PREFERRED QUALIFICATIONS:

  • Operating, maintaining, and troubleshooting chromatography work stations and process skids

  • Analyzing Data with Assay (SDS PAGE and Western Blot, SRID, BCA, Purity, Dialysis for rBV, ELISA, etc.)

  • Knowledge and experience working with automated high throughput process development equipment

  • Works on complex problems where analysis requires an in-depth evaluation of various factors

  • Initiates, directs and executes scientific research for innovation and process improvements

  • Exercises judgement in developing methods, techniques and evaluation criteria for obtaining results.

  • Demonstrates working knowledge of scientific principles and concerns

  • Participates in quality control tracking systems including change controls, deviations, CAPA, root cause analysis, etc.

  • Maintains project timelines

  • Updates group members on background and status of projects by giving oral updates or internal presentations.

  • Good documentation practices (GDP). Experience in writing standard operating procedures (SOP), batch records, and reports

  • Efficiency in computer software including Word, XL, PowerPoint, and also molecular modeling software is desirable,

  • Publish scientific findings in peer reviewed journals, represent our company in national and international meeting, report our findings

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.

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Downstream Process Development Manager - Vaccine

Principia Biopharma Inc.