Leadership

Engineering

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At Concerto Biosciences, we are obsessed with microbes. We dream of a healthier world where microbial ecology enables advanced medicines and environmentally-conscious agricultural practices. To unlock microbial ecology, Concerto uses a novel screening technology from MIT to construct and observe millions of microbial cocultures in parallel—each its own tiny universe of possibilities. Our technology generates a totally new type of microbiome data that allows us to identify groups of microbes that perform beneficial functions. We call these groups “ensembles”. We are currently in the preclinical stage for our first product, an ensemble to treat eczema—a chronic, irritating, and psychologically stressful skin disease that affects over two hundred million people. Our goal is to discover the first-ever treatment that provides totally safe, sustained relief for eczema patients. Concerto will go on to develop a multitude of ensembles that solve the world’s greatest challenges in human health, food production, and bioremediation.

The Concerto team is our most important ensemble. We believe the best human ensembles, much like microbial ensembles, are diverse—composed of individuals with different backgrounds, cultures, genders, and beliefs. We are committed to building a company where you belong and where your voice is heard.

As the leader and manager of our fermentation team, your primary goal will be to develop Concerto’s first live biotherapeutic product (LBP), “Ensemble No.2” (ENS-002), into a Phase I-ready drug product. To this end, you will help set up a new, scale-appropriate, and phase-appropriate GMP manufacturing laboratory. You will lead the development of a bioprocess for the manufacturing of the ENS-002 drug substance, coordinate with Quality to develop and validate release assays, draft and review SOPs, MBRs, provide technical oversight for product disposition, manage distribution and clinical labeling of drug product lots, and manage relationships with CROs, CDMOs and regulatory consultants.

This role will require experience in traditional GMP manufacturing of biologics as well as willingness to experiment with and innovate on CMC pipelines for LBP manufacturing. We don’t expect you to have experience performing all of the responsibilities listed below. Indeed, just as you help Concerto grow, we hope to contribute to your intellectual and professional growth. You’ll have the opportunity to gain new skills by working with our world-class team, and you’ll also have the opportunity to advance within the company by taking on higher responsibility roles.

As an early member of Concerto’s expanding team, you’ll also play a critical role in developing Concerto’s culture and translating our 

Develop and execute bioprocesses for small-scale drug substance manufacturing of the LBP ENS-002 (toward clinical trials for atopic dermatitis), including: (1) Process development and execution of microbial fermentation, cell harvesting, cryogenic and lyophilization preservation, and cell bank generation; (2) Coordination with the Assay Development team to develop drug substance and drug product manufacturing processes and in-process and end-of-process testing; and (3) Assess talent and equipment needs for the implementation of cGMP operations at Concerto

Author, review, and approve Development Reports to support cGMP documentation and regulatory filing

Develop and implement GMP SOPs, MBRs, Test Methods, and Specifications

Assist in cGMP Quality operations including tech transfer, product disposition, and investigations

Manage and assist with pilot manufacturing batches

Work with Regulatory colleagues to prepare FDA-facing materials for pre-IND meetings and IND filings

Contribute to individual and team success, including: (1) Work with team members to design and execute experiments; and (2) Exercise strong communication skills to contribute to company culture

Manage and direct activities of external CDMO and CRO partners

Bachelor's degree with 5+ years of experience, or Masters/PhD with 3+ years of experience, in microbiology, fermentation, chemical engineering, or related field

3-5 years of experience in pharmaceutical CMC for manufacturing LBP, cell therapy and biologics preferred. Proficiency in microbial fermentation and long-term preservation

Experience interacting with regulatory consultants and the FDA through written materials and in official meetings

Experience operating bioreactors or fermentors and developing processes to maximize biomass and viability

Experience operating tangential flow filtration, continuous centrifuge or similar cell harvesting equipment and developing cell harvesting processes that maintain cell viability

Demonstrated ability to work excellently in teams, as well as independently

Energized by a rapidly changing environment and excited to adapt research plans accordingly

Passion for science, desire to positively impact human health, and eagerness to innovate

Proactive, with a strong drive for problem solving and creative data exploration

Strong written and verbal communication; an ability to communicate technical material to expert and non-expert audiences simply and clearly

Experience leading a pharmaceutical CMC team

Familiarity with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic act

Lead Fermentation Scientist

Microbiology and Microbial Manufacturing

 Virtual, with the option of on-site work post-pandemic or continued virtual work.

 Concerto’s lab location: Pagliuca Harvard Life Lab, 127 Western Ave, Boston, MA 02134

At Concerto Biosciences, we are obsessed with microbes. We dream of a healthier world where microbial ecology enables advanced medicines and environmentally-conscious agricultural practices, and that starts by finding the right microbes for the job. Using a novel technology from MIT, we screen millions of microbe combinations in parallel to rapidly identify groups of microbes called “ensembles” that perform beneficial functions. This unprecedented scale of screening generates a totally new type of microbiome data, based on direct observation, that lets us map complex microbial interactions. We are currently in the preclinical stage for our first product, an ensemble to treat eczema—a chronic, irritating, and psychologically stressful skin disease that affects over two hundred million people. Our goal is to discover the first-ever treatment that provides totally safe, sustained relief for eczema patients. Concerto will go on to develop a multitude of ensembles that solve the world’s greatest challenges in human health, food production, and bioremediation.

The Data Scientist will be primarily responsible for designing and executing the analysis of our uniquely complex combinatorial datasets of microbial interactions in order to identify beneficial microbial “ensembles”. You will fully own the data analysis process of these datasets and will be able to innovate new methods of analysis and visualization, with the results of your work directly informing the direction of laboratory experiments to drive our discovery efforts. Major responsibilities include creating (1) standardized data cleaning methods, (2) exploratory analysis methods to quantify and compare microbial interactions, and (3) new and insightful data visualizations to communicate scientific results to a technical audience. As an early member of a growing team, your contributions will be transformative: working closely with the Director of Engineering and laboratory scientists, you will build out the core data analysis methods at Concerto, influencing upstream image processing and downstream predictive modeling. Finally, as our team grows, you’ll play a critical role in developing Concerto’s culture and putting our  

kChip is an ultra-high-throughput device that constructs and measures millions of defined microbial combinations (see links to publications below). kChip presents a completely new way of understanding the microbiome based on direct observation of microbial behavior. kChip data are microscopy images of millions of distinct microbial communities. We use image analysis techniques to measure their optical features, and you’ll dig into these features to discover how community behavior is related to community size, composition, environment, etc. Your work will be an integral component of our iterative discovery process between data analysis and laboratory experiments to engineer useful microbial communities from scratch.

Design and implement analysis techniques for combinatorial microbe interaction data with the strong statistical rigor required of large biological datasets, to identify beneficial groups of microbes working together

Build data visualizations for internal and external audiences

Standardize your analysis work into reusable code modules

Work with the Director of Engineering to inform upstream image processing and feature extraction methods used to generate data

Work with the Chief Scientific Officer and other scientists to inform the design of experimental screens, as well as follow-up experiments aiming to address working hypotheses

Identify opportunities to extract new value from kChip datasets

Bachelor’s degree with 3+ years of experience, or Masters/PhD, in data science, statistics, computational biology, or related fields

3-5 years of experience designing and implementing data analysis methods to interrogate complex datasets

A strong understanding of data cleaning and filtering processes

Experience implementing statistical inference, machine learning, and/or other analytical methods

Experience using Python and Jupyter Notebooks for data analysis, including the use of packages such as Numpy and Pandas

Familiarity with data visualization tools or software packages

Demonstrated track record of working well in team environments

Human-friendly, reproducible coding habits (well-commented, logically structured, etc.)

Experience analyzing scientific experimental data

Experience interfacing with relational databases such as PostgreSQL

Proficiency with version control software e.g. git

Click on "Apply" below! Please send your cover letter and resume to Keaton Armentrout at careers@concertobio.com.

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