Senior Research Investigator II - Analytical Development, Biologics | BioNJ Talent Services

Senior Research Investigator II - Analytical Development, Biologics

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

This position will lead analytical development activities related to analysis of therapeutic proteins in multiple areas such as characterization, formulations development, and process development

Roles and Responsibilities
Major activities include product characterization, method development/optimization and methods transfer to QC.
The role requires to lead work with CRO/ CMOs in addition to in-house work.
Serve as technical expert and SME with team to review analytical data and provide guidance on method development.
Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
Advance Amicus scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences.

Qualifications: 

Requirements
A PhD in chemistry, biochemistry or related field with 5+ years of relevant experience.
Lead biologics analytical methods development activities and support process development teams
Support therapeutic protein drug substance process development and process characterization, drug product formulation development and optimizations etc.
Build the scientific knowledge, capabilities, and strategies in biomolecular characterization that enable fast to clinic/fast to market product development and commercialization.
Knowledge with methods used for biopharmaceutical characterization including peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies is a plus.
Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.

Experience and Skills
Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is a plus
Experience in interacting with CROs/CMOs is preferred
Experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions
Team oriented and able to manage multiple projects cross various development stages.
Strong leadership, team building, organizational, communication and interpersonal skills.
Excellent oral and writing skills.

Travel
Position requires up to 25% USA and International travel

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Ph.D.