Principal Scientist, Early In-Process Analytics

hackajob is collaborating with GSK to connect them with exceptional tech professionals for this role.

Principal Scientist - Early In-Process Analytics

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Technical Research and Development is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we have invested in growing our Research and Development space in Cambridge. As such, we are creating a new hub for mRNA-based vaccine discovery and recombinant protein vaccine early development in Cambridge. We will bring together talent and expertise, building upon our long history of vaccine development, to create globally leading capabilities and cutting-edge technologies for vaccine development, adding to our robust portfolio targeting infectious diseases at every stage of life. Our new laboratories will be focused on the development of state-of-the-art methods to support deep product understanding, process and product development, and bringing cutting edge scientific methodologies to characterize new mRNA and CHO protein-based vaccines.

The In Process Analytics team within the Cambridge-based hub is looking for an Principal Scientist with strong expertise in sequencing technologies to support both the MET and NAV CoE teams. The role of Principal Scientist is expected to develop methods and provide leadership in building the current analytical platform for process intermediates, next-generation cell line development and early stage mRNA platform development to move vaccines faster to the clinic.

Key Responsibilities

As a Principal Scientist Early In-Process Analytics, you will be expected to take on the main core responsibilities as listed below:

• Design, develop and implement in-process analytical methods to interrogate sequence fidelity in support of both cell line development and mRNA transcript analysis;
• Serve as technical lead and subject matter expert on analytical methodologies for process intermediate results in a matrixed environment;
• Provide analytical development support and training to others within the Nucleic Acid Vaccines (NAV) and Mammalian Expression Technologies (MET) Centers of Excellence (CoEs);
• Collaborate with pre-clinical and analytical research and development teams to help drive innovation in analytical technologies, in support of project timeline deliverables and CMC submissions.
  
  

NOTE: The successful applicant may spend 1-2 weeks within the first 6 months in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA.

Basic Qualifications

• Ph.D in Biochemistry, Molecular Biology, Chemical Engineering, Biotechnology or Bioengineering with 3 years relevant experience; MS in Biochemistry, Molecular Biology, Chemical Engineering, Biotechnology or Bioengineering with 6 year relevant experience; BS in Biochemistry, Molecular Biology, Chemical Engineering, Biotechnology or Bioengineering with 9 year relevant experience;
• 2 years of experience leading the design, development and implementation of traditional and state-of-art sequencing methods for a variety of species (mRNA, plasmid DNA, whole cell genome) utilizing PacBio, Oxford Nanopore, MiSeq and related instruments and technologies;
• 1 year of experience designing and implementing state-of-art molecular analytics utilizing quantitative and digital PCR methods for gene detection/verification, genome quantitation and impurity assessments.
  
  

Preferred Qualifications

• A thorough understanding of biopharma vaccine development processes, with demonstrated ability to communicate across large, cross-functional teams to help propel projects forward;
• Extensive experience with Quality by Design, having developed fit-for-purpose, high throughput, in process analytics to support cell line development and cell line engineering;
• Experience with advanced genomics techniques to monitor insertions, deletions, mutations and other sequence variations in single cell genomes, plasmid DNA, and mRNA transcripts;
• Experience with residual impurity assay development for mRNA and protein drug substances;
• Advanced understanding of bioinformatic methods to deconvolute and condense NGS data for rapid data transfer and results reporting;
• Familiarity with sequence-dependent methods to interrogate the structure of mRNA and/or detect the presence of double-stranded RNA species;
• Experience setting up and running automated liquid handling systems for high throughput sample preparation;
• Experience in preparing clear, well-written protocols for ease of execution across multiple sites;
• Critical thinking ability with a focus on problem-solving to make rational decisions based on effective and accurate data interpretations;
• Positive, open and can-do mindset;
• Fluency in English.