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Analytical, Microbiology Lead

Company: Synlogic Inc
Location: Cambridge
Posted on: June 7, 2021

Job Description:

COMPANY OVERVIEW:

Synlogic is bringing the transformative potential of synthetic biology to medicine. We are building the premier Synthetic Biology platform to engineer bacterial Synthetic Biotic medicines which benefit patients in new ways

Using a platform that leverages reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways.

Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology.

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 challenge yourself and build your career while bringing the transformative potential of synthetic biology to patients then we'd love to hear from you.

POSITION SUMMARY:

The Analytical Development Scientist (or Sr. Scientist) will lead phase-appropriate bioassay analytical development for potency and characterization of live biotherapeutic product candidates within the CMC function. The scientist will be part of a dynamic and motivated development team to bring Synlogic's novel Synthetic Biotic medicines to clinical trials and eventual commercialization. This position requires in depth experience and knowledge in microbiology, and bioassay analytics with an understanding of how detection can be plate based or chromatographic in nature. Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) is a plus. This person will be the analytical team leader/representative on CMC teams and responsible for providing critical expertise in a cross-functional CMC teams.

KEY ACCOUNTABILITIES/DUTIES:

  • Participate in the clinical phase development of biological potency assays and establishment of product specifications.
  • Participate in the development of assays to assess microbiological relationships and analytical characterization of the Synthetic Biotics to define critical quality attributes of the drug substance and drug product.
  • Development of bioassays in support of the GMP manufacturing, with support from the group lead.
  • Prepare technical reports for all development activities.
  • Support preparation of regulatory/IND submissions, participate in their review and approval, and contribute in the development of strategies to comply with US and international regulatory standards.
  • Support a learning environment and foster a culture of scientific excellence through training, influence and leading by example.

QUALIFICATIONS & EXPERIENCES:

Required Qualifications & Experiences: The following qualifications and experiences are required for the position:

  • Ph.D. in microbiology, biochemistry or related discipline with at least 3 years of experience in bioassay development for clinical and/or commercial-stage biological products
  • Experience with microbial enumeration and other microbial assays used to characterize biotherapeutic products or probiotics
  • Experience developing quantitative assays measuring biochemical transformations, such as metabolite consumption in a microbial environment or conversion of enzyme linetic assay formats for use as potency assays
  • Experience developing plate-based assays to assess biological activity

Preferred Qualifications & Experiences: The following qualifications and experiences are preferred:

  • Experience qualifying/validating assays per ICH Q2(R1)
  • Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) is required.
  • Sound understanding of regulatory requirements for early stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.
  • Quantitative and qualitative qPCR/PCR techniques, or experience with nanostring nCounter technology
  • Cell counting for in vitro and cell-based assays including cellometer or flow cytometry
  • Endotoxin assay development for product release and Chracterizaion
  • SDS-PAGE Gels, both Coomassie staining and Western blotting for protein detection and quantitation
  • Experience managing people in project-based or functional teams.
  • Experience authoring and reviewing documentation needed for an IND submission or other regulatory agencies

VALUES & BEHAVIORS

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.

Synlogic is committed to creating a diverse and inclusive environment and is proud to be an equal opportunity employer, embracing diversity in all forms. Synlogic hires, trains, compensates and promotes talented Synlogicians regardless of age, color, disability, gender, gender identity or expression, genetics, national origin, race, religion, sexual orientation, veteran status, and other protected statuses as required by the laws and cultures of the geographies in which we operate. We believe in lifting others both inside and outside of the company, ensuring all of our community has access to opportunities and innovative therapies.

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 - facilitating a rapidly moving, fast-paced environment. 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 an inclusive, nimble environment.

We seek individuals who exemplify these behaviors and who encourage others to do the same.

Keywords: Synlogic Inc, Cambridge , Analytical, Microbiology Lead, Other , Cambridge, Massachusetts

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