Quality Assurance Specialist, Biologics | BioNJ Talent Services

Quality Assurance Specialist, Biologics

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
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 (CHART™) 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

The Quality Assurance Specialist will report to the Director, Biologics QA. The primary role of this position will be to support CMC and Quality Systems development activities for Biologics drug development programs at Amicus and ensure compliance to applicable regulations. This will include development programs through process validation including support of launch activities. The Quality Assurance Specialist will provide quality oversight support of CMC activities including manufacturing scale-up, method and process development and process validation, feasibility and engineering studies and stability programs. Oversight of CMO activities will be required to assure compliance to all applicable regulations.

Roles and Responsibilities
Provide Quality review and approval of CMO documentation including SOPs, analytical records, CAPAs, stability data, and reports for scale-up and engineering studies.
Conduct master batch record review and approval for biologics drug substance and drug product. Ensure changes are incorporated as specified in the approved change control.
Conduct review and approval of analytical methods for biologics drug substance and drug product.
Support Quality Engineering activities as assigned including: review of qualification/validation protocols and reports, metrics and data collection, risk assessment support, and continuous improvement projects.
Responsible for tracking actions resulting from biologics QA CMO oversight activities including any gap assessments, audit reports, and mock inspection activities. Ensures CAPAs are effective and implemented according to schedule.
Assist in data collection for Quality metrics management, analysis, and trending. Assists with quarterly and year-end reporting of manufacturing parameters, stability data, temperature excursions, deviations, and CAPAs.
Responsible for tracking QA actions from risk assessment activities for Drug Substance, Drug Product, and Analytical Development.
Provide onsite CMO oversight of Amicus product manufacturing as required.


A minimum of a BS or equivalent experience in the pharmaceutical/biotech industry
Must have at least 5-7 years’ experience in a Biologics/Vaccine manufacturing environment.
Experience with analytical methods is a plus.
Knowledge of the following regulations and guidance; 21 CFR Parts 210 & 211, 600 series, ICH Q8, Q9, Q10 and EU GMPs.

Experience and Skills
Strong written and verbal communication skills, and analytical problem solving and resolution skills.
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met.
Highly organized and ability to manage multiple priorities.
Effective interpersonal skills that foster cooperation and commitment.
Working knowledge of MS Office suite (Word, Power Point, Excel, Visio).

5-10% International travel may be required

Additional Job or Internship Information
Position Type: 
Full time job
Quality Assurance