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Downstream Process Development Engineer

Cambridge, MA · Science/Research
At Synlogic: We are Putting LIFE Into Medicines.
We are pioneers in the development of Synthetic BioticTM medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer. 
Every day our teams work tirelessly to drive to deliver on 4 aspirations:  
  • People:  LIVING each day with passion for building up and building out our Synlogic team
  • Platform:  Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
  • Products:  Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
  • Promise:  Building our company to launch multiple novel LIVING medicines mastering a new frontier in medicine
 We combine Human Logic and Science Logic to drive meaningful work, careers, and LIFE at Synlogic.  We foster a people-focused environment grounded in:  Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire:  Innovation, Integrity, High Performance, and LIFE Changing Results.
We continue to build and enhance our organization.  If you want a settled environment, pursuing a well-walked path then this environment is probably not for you.  If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you. 
The ideal candidate will report to the Head of Bioprocess Development and lead scientific activities related to the development of clarification (tangential flow filtration, centrifugation, etc.) and processes and analytical characterization for live bacterial products. Such activities will typically include designing, planning, setting up, performing, and documenting scientific experiments and established processes' routine performance. The successful candidate will lead the experimental design and have a deep scientific understanding of the physical, biological, and analytical principles of experiments performed and processes tested. This position requires a high level of discipline to follow procedures for performing and documenting laboratory work. It also requires in-depth experience and knowledge in biological analytics with an understanding of biological potency assays and Flow Cytometry, U/HPLC, and plate-based assays. The candidate will be responsible for providing critical expertise in a cross-functional CMC team.
  • Lead the development of cell-function relationships and analytical characterization of the Synthetic Biotics™ to define critical quality attributes of the drug substance and drug product
  • Lead assay development and testing to support high-throughput potency testing of internal process and formulation development samples and implement assay automation as needed
  • Safe, correct setup of scientific and light industrial equipment for handling, processing, and analyzing bacteria in active culture
  • Responsible for handling chemicals and biological cultures safely and aseptically and setting up and operating pumps, centrifuges, filtration devices, and similar equipment
  • Routinely use analytical equipment that may include UV/visible and fluorescence spectrophotometer, U/HPLC, pH and conductivity meter, gel electrophoresis apparatus, imager, pressure and flow meter, cell counter, and analytical or preparative balance
  • Expertise in Flow Cytometry, ELISA, SDS-PAGE Gel Electrophoresis, and other Cell Characterization instruments highly desirable
  • Prepare technical reports for all development activities
  • Support preparation of regulatory submissions, participate in their review and approval and contribute to the development of strategies to comply with US and international regulatory standards 
  • Ph.D. degree in chemistry, biochemistry, chemical engineering, process engineering, biomedical engineering, biology, microbiology, or related field
  • 0-2 years of experience in biopharmaceutical analytical development or downstream process development for clinical and/or commercial-stage biological products
  • Experience developing quantitative assays for enzyme kinetics, such as metabolite consumption or conversion for use as potency assays
  • Experience developing quantitative U/HPLC assays (e.g., RP, IEX, and SEC)
  • Experience developing quantitative UV-Vis and other spectrophotometric plate-based assays
  • Demonstrated experience qualifying/validating assays per ICH Q2(R1)
  • Experience with regulatory submission writing and review (i.e., INDs, BLAs, etc.)
  • Experience scaling up Filtration Processes for biologics clarification and/or purification
  • Highly proficient in Microsoft Excel, PowerPoint, and Word
  • Able to consistently prepare high impact, concise and influential presentations to Leadership Team
  • Experience with assays for live biotherapeutic products or probiotics
  • Understanding of microbial genetics and biology with knowledge and application of transcriptomics, proteomics, and metabolomics is highly beneficial
  • Quantitative and qualitative qPCR/PCR techniques
  • Analytical development on biologics such as SDS-PAGE, CE, ELISA, and gel-based assays
  • In vitro and cell-based assays including flow cytometry
  • Experience with the following methods and software:
  1. Tangential flow filtration
  2. Continuous centrifugation 
  • Occasionally the candidate will need to come early and/or stay late when the nature of the work demands. Ideally, such needs will be planned, but at times may occur with little or no warning.
  • Physical requirements include long-term standing or sitting or frequent movement throughout the office and laboratory. Moderate lifting, up to about 80 lbs., bending to access low cabinets, and reaching high shelves with or without a stepladder. Visual acuity for accurate measurements ≤ 1mm, reading a printed page. (Candidates who anticipate difficulty with stated or presumed physical requirements of this position are encouraged to discuss concerns with the hiring manager and Synlogic Human Resources to determine whether appropriate accommodations can be made. Synlogic is committed to fair hiring and employment practices. When possible, it will make reasonable adjustments to job requirements and/or work environment to prevent disqualification of a candidate solely based on physical limitation.) 
We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results.  Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.
Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting.  Our compassion for each other creates a safe environment for continuous risk taking and personal development.   We connect with our colleagues by having fun together. 
We take our work seriously and value integrity in producing the highest quality work.  We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team.  We encourage openness, direct feedback and transparency in decision-making to enable trust and maintain the nimbleness of the group
We seek individuals who exemplify these behaviors and who encourage others to do the same.   
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