We are seeking a Senior Scientist candidate to join the Analytical Research and Development Microbiology and Strategy Testing organization, a Quality Control - Good Manufacturing Practices (QC-GMP) laboratory that supports biotherapeutic clinical manufacturing in Andover, MA. The candidate will report directly to Microbiology Group Leader (Principal Scientist, Ph.D.).
The Senior Scientist candidate is mainly accountable for developing/optimizing the rapid virus testing technology using Next-Generation Sequencing (NGS) technology by working independently, collaboratively, and cross-functionally with colleagues. This role will be part of a team that will be involved in all aspects of the NGS workflow including library preparation, targeted enrichment, DNA/RNA sequencing, and Bioinformatics data analysis. The candidate will be responsible to understand the current industry virus testing requirements and capabilities and then develop and optimize a GMP method for the detection of adventitious viruses in biotherapeutics using NGS. The candidate is responsible for the method qualification, validation, successful implementation of the technology, and training of staff.
The candidate also assists with experiments involving molecular biology skills such as PCR testing, DNA/RNA extraction, and molecular microbial identification in the GMP Microbiology laboratory.Key Responsibilities:
- Identify, develop, and implement new technologies to accelerate NGS workflows.
- Participate in all aspects of NGS workflow including sample preparation, library generation, DNA sequencing, and data generation.
- Develop and execute complex molecular biology protocols, specifically various NGS-based library preparation and characterization protocols, using established molecular biology techniques and novel solutions.
- Provide technical support to the existing methods and analysis solutions.
- Troubleshoot technical problems and participate in the continuing development and optimization of existing and new protocols.
- Communicate with internal stakeholders to provide develop customs analysis solutions and provide troubleshooting support.
- Adapts well to the changing platform needs, in workflow, projects, and other tasks as required by the platform.
- Keep records of development work and testing in a GMP environment utilizing electronic notebook solutions.
- Follow standard operating procedures (SOP) and current Good Manufacturing Practices (GMP) on a daily basis.
- Write technical reports and method/instrument SOPs.
- Collaborate with cross-functional teams to design and execute verification and validation studies for regulatory submissions.
- Produce, analyze, and communicate scientific insights to the scientific and management teams.
- Demonstrate the ability to resolve project hurdles by applying technical expertise in molecular biology.
- Accountable for the accuracy, organization, and interpretation of testing results.
- Interprets results and records observations. Identify and solve technical problems.
- Apply knowledge of sequencing to multiple cross-functional NGS projects in a research and development setting
- Experience with a broad range of lab techniques, including cell culture, cell-based assays, and assay development would be a plus.
- Represent the group at internal conferences.
- Ph.D. with 0-3 years of experience in molecular biology, virology, bioengineering, or related disciplines, Master's Degree with 5+ years of experience, or Bachelor's Degree with 7+ years of experience.
- Extensive experience with molecular biology techniques such as DNA/ RNA extraction, PCR, qPCR/ddPCR, fragment analyzer, Sanger sequencing, Next-Generation Sequencing workflow (including WGS, RNA-seq, and targeted sequencing), and bioinformatics analysis of NGS data.
- Advanced understanding of NGS platforms, specifically those utilizing the synthesis by sequencing technique (i.e., Ion Torrent and Illumina platforms).
- Excellent understanding of the underlying technical principles of next-generation sequencing chemistries and workflows, associated instrumentation platforms, data analysis, and interpretation algorithms.
- Experience in assay and product development.
- Practical method qualification and validation experience using quality by design.
- Familiarity with instrument and software validation regulations.
- Experience with virology and microbiology
- Ability to work independently and adapt under aggressive and/or changing timelines.
- Demonstrated ability to deliver high-quality results independently and collaboratively.
- Adaptive and a quick learner, efficient in multi-tasking and troubleshooting.
- Bioinformatics and statistics skills, including experience with Python or R (Scripting experience in coding languages (i.e., bash, awk, python, R, etc.) is preferred.
- Familiarity with automation tools
- Familiarity with eLN and LIMS system
- Experience with Microbiology testing
- Knowledge of and/or experience with other sequencing platforms (i.e., PacBio Sequel II).
- Experience mentoring junior staff is highly preferred.
Position requires occasional light lifting and periods of standing, sitting, or walking.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
First shiftOther Job Details
Relocation Support Available
Work Location Assignment:On Premise
On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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Research and Development