Scientist/Sr. Scientist Product Development, Process Analytical Sciences

Alnylam Pharmaceuticals, Inc. Cambridge , MA 02138

Posted 5 months ago

Scientist/Sr. Scientist Product Development, Process Analytical Sciences

Overview

Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016 and 2017.

The successful candidate will be responsible for process development, formulation, scale up, and process characterization of RNAi products. The candidate will work closely with cross-functional teams and contract manufacturing organizations on drug product development, process transfer and oversight of manufacturing processes.

Summary of Key Responsibilities

  • Formulation process development, optimization, scale-up and pre-validation process and product characterization

  • Management of in-house and contract manufacturing formulation and filling processes

  • Technical support for optimization of contract manufacturing processes

  • Author and review technical protocols and reports in support of late phase manufacture and process characterization activities

  • Contribute to strategic technical discussions and present progress at internal and external scientific meetings

  • Responsible for technical input in the Quality section of regulatory filings

  • Position requires 10-15% travel and 50% lab work

Qualifications

  • Degree in chemistry, chemical engineering, biochemical engineering, or pharmaceutical sciences.

  • Ph.D. with 5 years of hands-on formulation and process development experience including process transfer and management of contract manufacturing

  • Master's degree with 10 years of hands-on formulation and process development experience including process transfer and management of contract manufacturing

  • Hands-on experience in parenteral drug product formulation and process development

  • Hands-on experience in analytical methods for characterization of drug products and processes

  • Experience in filtration technology, including sterile filtration, diafiltration and ultrafiltration

  • Working experience with cGMP manufacturing

  • Experience in process transfer and managing contract manufacturing

  • Familiarity with cGMP, ICH and regulatory guidelines

  • Excellent organizational and communication skills

  • Demonstrated strong operational execution and problem-solving skills

  • Desire to work in a fast-paced, deadline-driven environment

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

#LI-CM1


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Scientist/Sr. Scientist Product Development, Process Analytical Sciences

Alnylam Pharmaceuticals, Inc.