Bioprocess Development Scientist

Syntis Bio is a clinical-stage biopharmaceutical company developing oral therapies that harness the small intestine’s unique biology to provide more accessible, effective and sustainable solutions across the healthcare spectrum, from rare genetic disorders to the world’s most prevalent conditions. Syntis is rapidly advancing a pipeline of oral therapies engineered for optimization in the small intestine, the body’s nexus for metabolic control, digestion and drug absorption.

The company’s lead program, SYNT-101, is a once-daily oral pill for the treatment of obesity that mimics the effects of gastric bypass surgery. SYNT-101 leverages the power of SYNT™ (SYN thetic T issue-li ning), an oral technology developed by Syntis founders that delivers a safe, transient polymer coating to the duodenum that controls nutrient uptake, as well as enhances both gut-restricted enzyme efficacy and systemic drug absorption for up to 24 hours.

The company is also developing a portfolio of enzyme replacement therapies to treat orphan metabolic and broad digestive disorders. Syntis is headquartered in Boston and has raised >$50 million to date from leading life sciences and strategic investors, as well as non-dilutive grant funding. For more information, please visit (Use the "Apply for this Job" box below). and follow us on Linked In.

Your Impact at Syntis: We are developing therapeutic enzymes for metabolic disorders for delivery with a novel drug delivery technology, SYNT.SYNT is a mucoadhesive polymer formed in vivo in the gastrointestinal tract that can be used to increase the intestinal residence time allowing improved efficacy of orally delivered enzymes. Syntis Bio is seeking a scientist to lead the upstream and downstream process development of the enzymes to be delivered with this technology.

This role will be essential in driving advancement of multiple programs into early phase clinical studies. In addition, the scientist will work with the regulatory, nonclinical, formulation development, and clinical teams, as well as external partners. The role is on-site and located in Dorchester in Boston, MA.

The Responsibilities:

• Lead the implementation of upstream processes for microbial fermentation and downstream processes for harvesting, cell lysis, and enzyme purification at CDMOs.
• Management of CDMOs for tech transfer, process development, analytical development, and GMP manufacturing.
• Implementation of analytical methods for establishing purity and activity of enzymes and execution of methods to support formulation development of the enzymes incorporated into the SYNT technology.
• Support CMC Drug Substance sections of regulatory filings including INDs, BLAs, and NDAs.
• Interpret, analyze, present, and properly record data.
• Prepare documents and presentations that encompass project progression.

The Ideal Skills:

• PhD (with 1-3 years work experience) or B.S./M.S. (with 8+ years of work experience) in chemical/biological engineering, biochemistry, or related discipline (level will be commensurate with experience).
• Experience with management of CDMOs through process development, analytical development, and GMP manufacturing.
• Experience with microbial fermentation including process scaleup.
• Experience with cell lysis and purification operations such as homogenization, flocculation, depth filtration, tangential flow filtration, and chromatography including process scaleup.
• Experience with a wide range of analytical techniques for characterization of enzymes including RP-HPLC and SE-HPLC.
• Scientifically driven to overcome complex technical challenges during process development and scaleup.
• Strong record of deliberate mentorship or management of junior level staff.
• Proven ability to lead the scientific direction of a project.
• Strong written and oral communication skills for technical and non-technical audiences.
• Conscientious team member with experience taking and giving constructive feedback.

Syntis Bio is pleased to offer:

• Medical, Dental, and Vision health plans.
• Flexible time off.
• Bonus and Equity plans.
• Flexible Spending Account plan.
• 401(k) retirement plan.
• Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance Plans

We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by applicable laws.

Syntis Bio uses E-Verify to confirm the identity and employment eligibility of all new hires.

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