Scientist / Senior Scientist – Microbiologist (Manufacturing)

Chief Medical Officer

Leadership

Apply via LinkedIn

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 first automation engineer at Concerto, you will lead and manage the implementation of an integrated, automated laboratory workflow. The outcome will be greater efficiency in throughput via an increase in speed and decrease in human labor. You will work with Concerto’s co-founders, lab scientists, data scientists, and consultants to formulate a high-level automation plan that achieves milestones in efficiency improvement. Your implementation of this plan will require (a) onboarding commercially available equipment (e.g. robotic arms, liquid handlers, etc.) and (b) working with machine shops and/or CROs to design and build custom hardware. You will oversee use of automation equipment and iterate on designs and protocols as necessary. As an early member of Concerto’s expanding team, you’ll also play a critical role in developing Concerto’s culture and translating our 

Each broad step of our laboratory workflow, currently operated manually, has the potential to become automated:

: We build banks of isolated microbial strains from samples, e.g. human skin swabs.

: We retrieve biobank plates (96-well format) from the freezer and perform various liquid handling operations to prepare for combinatorial screening.

Microwell array loading (proprietary hardware)

: We load microwell chips with screening inputs. You can read about the technology’s predecessor, kChip (

), and its application to a basic science problem (

: We move microwell chips on and off a microscope stage to image them at various time points.

Help design a step-by-step, multi-year plan for an integrated, automated laboratory workflow (see above) that accounts for Concerto's immediate and long-term laboratory needs and associated efficiency gains (Note: Depending on your experience level, this may be done with the aid of consultants)

Implement this plan by: (a) Interacting closely with Concerto’s laboratory scientists (equipment operators) and data engineers/scientists (users of the workflow’s outputs) to define the system’s functional requirements; (b) Leveraging your professional network of machinists, designers, vendors, and CROs to aid in the design and/or onboarding of equipment; and (c) Overseeing and improving the onboarding and use of all equipment via well-written operation protocols, design iterations, QC and troubleshooting, and user feedback

3-5 years of experience as an automation engineer

A demonstrable skill set covering at least one of the following areas: Onboarding, using, and developing laboratory automation equipment; Designing sophisticated liquid handling and/or microscopy automation workflows

Some fluency with standard/existing automation equipment, e.g. stackers, robotic arms, and liquid handlers

Up-to-date with current machine shops, vendors, CROs, and designers by networking through SLAS, LRIG, etc.

An ability to view new conflicts/problems as “puzzles” and rapidly propose and implement solutions that take all the dimensions of the puzzle into account (logistics, priorities, resource constraints, etc.)

An ability to collate and synthesize input from teammates and integrate team feedback into designs

A motivated and self-driven attitude and an ability to work independently

An organized work style and ability to drive rigorous documentation standards

Bachelor’s or advanced degree in engineering, science, etc.

Familiarity with software that may aid the design, programming, operation, and/or maintenance of equipment

Familiarity with high-throughput screening paradigms, microbial samples, and fluorescence-based assays

Strong leadership skills, with the potential to supervise future automation employees

Senior Automation Engineer

Engineering

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

Lead Analytics Scientist

As a (Senior) Scientist – Microbiologist on the R&D team, you will play a critical role in the discovery phase of Concerto’s future microbial products. The ultimate output of your work will be the nomination of “hit” microbial ensembles, strains, or derivatives for future development. Your responsibilities will span protocol design and hands-on execution of (1) microbial biobanking and characterization, (2) assay development, (3) high-throughput combinatorial screening (using Concerto’s proprietary platform), and (4) validation experiments. You will work closely with an interdisciplinary team of laboratory scientists, an automation engineer, and data scientists to plan and execute these experimental workflows.

Microbiology laboratory experience is required, though we do not necessarily expect you to have experience performing all the responsibilities listed below. We are committed to your professional development, and you will develop and hone some of these skills at Concerto. As an early member of Concerto’s expanding team, you’ll also play a critical role in developing Concerto’s culture and translating our 

Manage, design, and execute scientifically rigorous laboratory experiments that draw on methods across microbial (co)culture and molecular biology (e.g. plasmid construction, PCR, qPCR, and RNA and DNA extraction)

Design, develop, and optimize new quantitative functional assays of bacterial and fungal strains

Help design and implement standard operating procedures for biobanking (construction, characterization, information management, and maintenance) and combinatorial screening of microbes

Report results from laboratory experimentation through the generation of analyses in Matlab, Python, R, Prism, Origin, Exel, or equivalent (note: the analysis of large screening datasets is accomplished by the data team)

Interpret and communicate experimental outcomes, and recommend follow-up experiments

Participate in high-level planning of ensemble discovery strategies based on personal experience and scientific learning (e.g. literature, conversations with experts)

Participate in low-level planning of week-by-week experiments based on quarterly goals and data discussions

Collaborate with scientists, engineers, and research associates, with willingness to learn from and teach others

PhD in Microbiology, Molecular Biology, Bioengineering, or related field (or: BS or MS + ≥3 experience in industry)

Laboratory experience, including: (a) Microbiology techniques, especially aseptic handling of samples, microbial culture, and engineering of bacteria and/or fungi; (b) Modern DNA cloning methods and bioinformatics tools for construct design; and (c) Design, optimization and implementation of 

Broad knowledge base across the following fields: microbiome science, microbial ecology, microbial physiology, and medical and/or environmental microbiology

Demonstrated ability to rigorously problem-solve, including: forming and testing hypotheses, troubleshooting, interpreting data, and thinking creatively

Demonstrated ability to create, maintain, and teach standardized methods and protocols

A track record of working well across interdisciplinary teams with excellent interpersonal, communication and presentation skills (oral and written formats)

≥1 year of experience in a fast-paced start-up environment

Knowledge of microbial genetics, biochemistry, and metabolism

Experience with high-throughput phenotypic screening platforms

Scientist / Senior Scientist – Microbiologist (R&D)

Microbiology and Microbial Manufacturing

: Option to work on-site in Boston, MA, or remote.

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 Bioinformatics Software Engineer will be primarily responsible for moving our computational pipeline into production, enabling faster microbial ensemble discovery. As an early engineer on the team, you will have a significant impact on the direction of the data processing infrastructure and you will be encouraged to think critically about how to best handle the novel kinds of microbial interaction data we are generating. You will work closely with the Lead Data Scientist to define the backend data model and lay the foundation for a scalable and quick-turnaround data processing practice at Concerto, enabling a tight feedback loop between engineering and laboratory sides. Your work may touch all aspects of the backend system, from algorithm development and cloud deployment for image processing software through to data storage and API design.

While deep experience in every individual aspect of this system is not required, you should have a working familiarity with standard components of a data processing pipeline and a willingness to jump in and get up to speed quickly. The primary data type you will be handling as an input is image data. NGS data, which we may work with at some point in the future, is not the current focus. 

Design and implement an automated, cloud-based pipeline for scalable and repeatable processing of laboratory image data

Work with data scientists and laboratory scientists to iterate on data storage and API designs to facilitate analysis of novel data describing microbial behaviors and interactions

Manage and optimize cloud deployment of analysis pipelines

Integrate monitoring tools and automated tests into deployed workflows to enable efficient debugging

Maintain clear documentation for the tools you build

Implement unit tests and CI testing as a consistent practice to ensure code correctness

Promote code quality and readability through regular code reviews

≥5 years of experience as a Software Engineer

Experience writing well-formatted Python code in a production environment

Experience maintaining and deploying a data processing pipeline to cloud services such as AWS

Familiarity with database schema design patterns

Willingness to learn about the biological context of the data under analysis to inform backend design

Clear communication styles and a willingness to collaborate across engineering and laboratory science teams

≥1 year of experience in a fast-paced startup environment

Familiarity with infrastructure-as-code tools such as Terraform or CloudFormation

Prior experience working on image analysis algorithms

Bioinformatics Software Engineer

Data Scientist

Machine Learning Engineer

The Senior Software Engineer will be primarily responsible for moving our data processing pipeline into production. This will involve implementing a robust and repeatable job running system for batch, image-based biological datasets, managing the deployment of this system into a cloud environment, and designing the data model to oversee data flow and access throughout the pipeline. As an early engineer on the team, you will have a significant impact on the direction of the data processing infrastructure starting from the ground up and you will be encouraged to think critically about how to best handle the novel kinds of microbial interaction data we are generating. There are opportunities for your work to touch all aspects of the backend system, from image processing algorithm development through to data storage and API design. You will work closely with the Lead Data Scientist to lay the foundation for a scalable and quick-turnaround data processing practice at Concerto, enabling a tight feedback loop between software engineering and laboratory sides.

While deep experience in every individual aspect of this system is not required, you should have a working familiarity with standard components of a data processing pipeline and a willingness to jump in and get up to speed quickly. Our current stack is written in Python, so fluency with it is strongly preferred.

Work with data scientists and laboratory scientists to iterate on data storage and API designs to facilitate analysis of novel combinatorial datasets describing microbe behavior

Promote code quality and readability through regular code reviews and the use of unit tests and CI testing

5+ years of experience as a Software Engineer

Experience using AWS cloud technologies e.g. EC2, RDS, and Lambda

Experience with infrastructure-as-code tools such as Terraform or CloudFormation

Experience writing well-formatted Python code in a collaborative, production environment