Senior Analytical Development Specialist

7 days ago


Brockton, Massachusetts, United States PTC Therapeutics Full time

About the Role

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This position is part of PTC Therapeutics, a company dedicated to developing and commercializing innovative therapies for patients with rare genetic diseases. As a Senior Analytical Development Specialist, you will play a key role in supporting and contributing to the analytical development function for early-stage and late-stage development projects.

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You will serve as an expert in analytical development for various pharmaceutical dosage forms, providing analytical support to the Process Chemistry and Formulation Development groups during the development and optimization of drug substance and drug product, respectively. This includes working on the CMC analytical development of New Chemical Entities (NCEs) and overseeing Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to achieve the company's goals for US and global markets.

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Main Responsibilities

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  • Act as an internal analytical leader and expert to support product development from project initiation to commercialization.
  • Develop analytical methods for NCEs and drug products.
  • Coordinate the development of analytical and control tests for API, starting materials, process intermediates, and drug product at PTC and at CMOs; facilitate analytical method transfer and validation at external CMOs.
  • Compile data from internal and external sources and provide data summaries to management.
  • Provide analytical support to early and late-stage discovery programs, as needed.

Requirements

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  • Master's degree in a relevant scientific discipline and a minimum of 7 years of analytical development experience in a pharmaceutical, biotechnology, or other related environment OR a PhD in a relevant scientific discipline and a minimum of 5 years of analytical development experience in a pharmaceutical, biotechnology, or other related environment OR equivalent education and/or experience.
  • Experience in the development, validation, and implementation of analytical Standard Operating Procedures (SOPs) that employ a range of analytical methods.
  • Hands-on experience with the identification, sourcing, and maintenance of analytical instruments.
  • Demonstrated experience in overseeing analytical activities at external CMOs, and ability to troubleshoot analytical methods.
  • Working knowledge of Laboratory Information Management Systems (LIMS) and computerized data systems.

Benefits

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  • A competitive salary, estimated to be around $120,000-$150,000 per year, based on industry standards and location.
  • The opportunity to work in a fast-paced, matrixed team environment consisting of internal and external team members.
  • A comprehensive benefits package, including health insurance, retirement plans, and paid time off.

What We Offer

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  • A collaborative and dynamic work environment.
  • The chance to contribute to the development of innovative therapies for patients with rare genetic diseases.
  • Ongoing training and professional development opportunities.

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