Senior Associate Scientist, Drug Substance CMC

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Job description

Description

Senior Associate Scientist, Drug Substance CMC

What's in it for you?

In this role, you will have an opportunity to contribute to Mersana's Antibody Drug Conjugate (ADC) Purification Platform, be responsible for the development of scale-able and robust downstream processes, and support technology transfer efforts leading to clinical and commercial GMP manufacturing for ADCs. You will be involved in projects from early to mid and through late stage, including process characterization and validation, as you help streamline and simplify our purification platforms with the goal of implementing them in the clinic right away.

How do you know if you are the right fit?

You will possess:

• Technical expertise at design, execution and data interpretation of experiments related to development, optimization, scale-up of all steps in an ADC
• Knowledge of BioConjugation and purification processes
• The ability to Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
• Experience in applying DOE and other advanced statistical techniques to design experiments related to process development and characterization
• Familiarity with authoring high-quality documents, including technical reports, SOPs, experimental protocols, drafting tech transfer related documents (process description, process flow diagram, tech transfer, etc.), reviewing batch records, and sampling plans
• The ability to contribute to MFG floor activities and to scale up activities, conduct facility fit exercises and provide technical support (process/operational gap identification, facility fit and troubleshooting) to MFG groups at clinical and commercial manufacturing sites

The other stuff

This is typically a role best suited for candidates Chemistry, Biochemistry or Biotechnology related discipline with 0-5 years of experience.

To be successful, you will also possess:

• Solid theoretical knowledge and hands-on experience in purification technologies and analytical characterization
• Experience in multi-step, organic synthesis including purification and characterization methods (SEC, IEX, RP HPLC, LC/MS, NMR, and UV)

• Hands-on experience with purification unit operations including different modes chromatography, fluent in AKTA operations and UNICORN software, working knowledge of UF/DF, filtration, centrifugation
• Previous experience with automated preparative HPLC, SPPS, and macromolecules (synthetic polymers, carbohydrates) preferred
• A self-motivated, accountable, and inquisitive attitude, and have excellent organizational, communication, and presentation skills
• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
• Demonstrated ability to work both independently and as a member of local / global teams

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.