Leadership

Engineering

Apply

: Full-time position with a competitive compensation and benefits package

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 Concerto CMC, your primary goal will be to complete the manufacturing of our first product, “Ensemble No.2” (ENS-002), for use in first-in-human studies. To this end, you will develop Concerto’s CMC strategy and build the appropriate team to execute this strategy. Leading the CMC team, you will manage and technically guide bioprocess, analytical, and quality efforts. You will work closely with the VP of Product Development to coordinate with Concerto’s regulatory and clinical advisors during the design of first-in-human studies, and you will facilitate the integration of CMC learnings into the first-in-human study design.

At first, the CMC team will be small and will require you to “wear many hats” both inside and outside the laboratory. Your work will therefore span both technical execution and team building, drawing on experience you have in: GMP manufacturing of LBPs; analytical development of in-process and release assays; drafting and executing SOPs for QA/QC; preparing materials for regulatory agency review; and directly interacting with regulatory agencies.

While experience in the areas outlined above is desirable, comprehensive expertise is not essential. Just as you help Concerto grow, we hope to contribute to your intellectual and professional growth. Some problems you work on may be entirely new to the field, and you’ll have a world-class team behind you as you figure out how to solve them. Finally, as an early member of Concerto’s expanding team, you’ll play a critical role in developing Concerto’s culture and translating 

Build Concerto’s CMC development strategy to advance ENS-002 into first-in-human studies

Build Concerto’s CMC development team to execute on CMC strategy, which may be composed of complementing FTEs, PTEs, and consultants

Lead, oversee, and support the various CMC development efforts including cell bank construction; pilot manufacturing runs; and GMP drug substance runs, analytical assay development, QA, and QC

Champion effective collaboration across fermentation, analytical, and quality

Facilitate the integration of CMC learnings into first-in-human study design

Contract, evaluate, and manage relationships with CDMOs, CTOs, and other contract organizations

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

Work with regulatory colleagues to prepare materials for regulatory agency approval review

Work with team members to design and execute CMC experiments

Exercise strong communication skills to contribute to company culture

A PhD and 10+ years of experience in biology, microbiology, pharmaceutical sciences, or related fields

5+ years of experience leading pharmaceutical CMC teams

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

Deep understanding of the regulatory requirements for the development of LBPs towards clinical studies, including a strong familiarity with relevant sections of 21 CFR

Demonstrated ability to work both independently and collaboratively on teams

Adaptability in a rapidly changing environment and skills needed to pivot research plans accordingly

Intrinsic passion for science, human health, product development, and/or innovation

A proactive work style, with a strong drive for problem solving and creative data exploration

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

Demonstrated experience advancing discovery LBP leads into clinical trials

Experience with skin microbiome science, and skin products

The technology used to discover ENS-002 is described in 

Please send your cover letter and resume or CV to Dr. Bernardo Cervantes at careers@concertobio.com.

All employees must be fully vaccinated against COVID-19, and all new hires must be fully vaccinated by the time they start employment. During the interview process, you will be asked to confirm that, if hired, you can satisfy this express condition of employment. At present, an individual is deemed “fully vaccinated” when that person has received, at least 14 days prior, either the second dose in a two-dose COVID-19 vaccine series (e.g., Pfizer or Moderna) or a single-dose COVID-19 vaccine (e.g., Johnson & Johnson). The Company will make reasonable accommodations under applicable law for qualified individuals to enable them to perform the essential functions of the job, unless doing so would create an undue hardship for the Company.

Director of CMC

As Concerto’s Senior Engineer – Bioprocess Development, your primary goal will be to develop a fermentation process to manufacture Concerto’s first live biotherapeutic product (LBP), “Ensemble No.2” (ENS-002),  towards a Phase I-ready drug product. To this end, you will help set up a new, bench-scale, and phase-appropriate GMP manufacturing laboratory. You will build and execute the strategy to develop a bioprocess for the manufacturing of the ENS-002 drug substance, coordinate with Analytical and Quality to develop and validate release assays, draft and review SOPs, MBRs, provide technical oversight for product disposition, and manage relationships with CROs, CDMOs and regulatory consultants.

This role will require experience in traditional cGMP manufacturing of LBPs as well as willingness to experiment 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 play a critical role in developing Concerto’s culture and translating 

Lead the development and execution of bioprocesses for small-scale DS manufacturing of the LBP ENS-002

Process development and execution of microbial fermentation, cell harvesting, cryogenic and lyophilization preservation, and cell bank generation

Coordination with Assay Development to develop in-process and end-of-process testing

Assess talent needs and equipment needs for the implementation of cGMP operations at Concerto

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

Assist in cGMP Quality operation including tech transfer, and product disposition

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

Manage and direct activities of external CDMO and CRO partner

Masters/PhD with 5+ years of experience, in chemical engineering, microbiology, fermentation, or related field (Or Bachelor's degree with 7+ years of experience)

5 years of experience in pharmaceutical CMC for manufacturing LBP, cell therapy and biologics preferred

Proficiency in microbial fermentation and long-term preservation

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

Click "Apply" below to submit your resume via LinkedIn.

Senior Engineer – Bioprocess Development (Fermentation)

As Concerto’s Senior Scientist – Analytical Development, your primary goal will be to develop a suite of analytical methods in microbiology and molecular biology to be used in the manufacturing and formulation of Concerto’s first live biotherapeutic product (LBP), “Ensemble No.2” (ENS-002). You will be responsible for refining, implementing, and transferring the methods you develop to Quality Control and external vendors. You will lead the development of phase-appropriate assays for the manufacturing of the ENS-002 drug substance, coordinate with the bioprocess development effort, and help manage relationships with CROs and Quality consultants.

This role will require experience in GxP analytical development, microbiology, and willingness to experiment and innovate in analytical development for LBPs. 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 play a critical role in developing Concerto’s culture and translating 

Develop, write, and execute methods in microbiology and molecular biology for release testing, stability studies, and bioprocess method validations that enable clinical advancement

Lead analytical development and method validation in a phase appropriate manner to advance preclinical programs from R&D to clinical testing

Set product specifications and execute stability studies to support clinical programs

Prepare CMC documentation in support of pre-IND, IND, BLA, and NDA submissions and amendments, including data packages for meetings with regulatory authorities

Responsible for the refinement and transfer of methods to QC and external vendors

Assess talent needs and equipment needs for the implementation of CMC operations at Concerto

BS degree in Microbiology, Chemistry, Analytical Chemistry, Medicinal Chemistry, or equivalent with a minimum of 7 years (or MS/PhD with 5 years) experience in method development in pharmaceutical industry is required

Experience in analytical and regulatory requirements for cGMP manufacturing and testing with knowledge of ICH, USP, EP, and FDA guidances for drug substances and products

Experience in setting specifications and analytical characterization of early clinical phase products

Experience in developing analytical methods for qPCR, RT-qPCR, NGS, live/dead assays, and CFU quantitation

Experience working as a microbiologist in assay development in the biopharmaceutical industry highly preferred

Experience in writing technical reports, SOPs, and regulatory documents preferred

An ability to communicate technical material to expert and non-expert audiences simply and clearly

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

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

Experience leading a GxP Analytical development team

Experience with microbiology and fermentation

Senior Scientist – Analytical Development

As a Research Associate – Fermentation, you will join Concerto’s effort to advance the development of microbial ensembles into products. Some characteristic responsibilities include: executing basic microbial fermentation techniques during bioprocess development toward the manufacturing of Concerto’s first live biotherapeutic product (LBP), “Ensemble No.2” (ENS-002); assisting with materials preparation and execution during fermentation runs; and supporting proper documentation of activities in the laboratory. You will need to be meticulous with your work, highly communicative, and able to work closely with a team.

This role will require laboratory experience in microbiology and fermentation of LBPs. 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 play a critical role in developing Concerto’s culture and translating 

Utilize established techniques and methods in microbiology and fermentation in support of bioprocess development

Contribute to the design and development of a fermentation process for ENS-002

Contribute to proper documentation and technical report writing of CMC activities

Follow established SOPs in an accurate and meticulous manner

Prepare reagents and materials in support of method development and fermentation runs

Maintain accurate, meticulous, and timely records

Maintain proper inventory of reagents and materials in coordination with Concerto’s Lab Manager

BS degree with 2+ years of laboratory experience or MS degree with 1+ years of laboratory experience

Extensive experience within a laboratory applying basic biology techniques

Good understanding of standard microbiology techniques, including sterile technique

Ability to analyze data and write technical reports

Experience working in a cGMP laboratory environment

Experience with microbiology and fermentation techniques

Research Associate – Bioprocess Development (Fermentation)

As a Research Associate in Analytical Development, you will join Concerto’s effort to advance the development of microbial ensembles into products. Some characteristic responsibilities include: executing on a suite of analytical methods in microbiology and molecular biology to be used in the manufacturing and formulation of Concerto’s first live biotherapeutic product (LBP), “Ensemble No.2” (ENS-002); assisting with materials preparation and execution during fermentation runs; and supporting proper documentation of activities in the laboratory. You’ll need to be meticulous with your work, highly communicative, and able to work closely with a team.

This role will require laboratory experience in microbiology and analytical development for LBPs. 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 play a critical role in developing Concerto’s culture and translating 

Utilize established techniques and methods in microbiology and molecular biology to generate data in support of method development, qualification, and routine testing

Contribute to the design, development, optimization, and validation of analytical methods

Perform literature search and review to inform assay development

Contribute to proper documentation and technical report writing of laboratory activities

BS degree with 2+ years of laboratory experience or MS degree with 0-1 years of laboratory experience

Extensive experience with in a laboratory applying basic biology techniques

Experience with nucleic acid purification and quantification methods including qPCR, RT-qPCR, and NGS

404

Not Found