Lead Fermentation Scientist

Concerto Biosciences

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.

Role Description

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 core values into practice.

Responsibilities

• 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
• Embody Concerto’s core values in your work

Required Qualifications

• 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

Preferred Qualifications

• Experience leading a pharmaceutical CMC team
• Familiarity with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic act
• Experience with skin microbiome science

Relevant Links

• Our core values

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