Scientist, Quality Control | BioNJ Talent Services

Scientist, Quality Control

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

COMPANY PROFILE
We are passionate about what we do
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 successful candidate will be highly motivated individual ready to work within a science-focused, collaborative, multidisciplinary drug substance and drug product development environment.

The Associate Scientist, Quality Control position will have demonstrated the ability to handle complex biological manufacturing and quality control testing projects. This position will focus on document and data review of drug substance and drug product release and stability testing. Working closely with QC Manager to assist in troubleshooting issues raised by CROs will also be required.

ROLES AND RESPONSIBILITIES
Review data from batch release and stability programs conducted at CMO.
Along with QC Manager and CMO, examines current analytical methods in order to investigate, create and potentially develop new and improved methods and technologies which can benefit ongoing programs.
Evaluate data for trends indicative of product performance, method performance, or analyst performance.
Serve on departmental, interdepartmental, and project teams
Adhere to all relevant compliance regulations

Qualifications: 

REQUIREMENTS
BS in Analytical Chemistry, Biochemistry (or relevant discipline), must have a minimum of 2 years of work experience
MS in Analytical Chemistry, Biochemistry (or relevant discipline), must have a minimum of 0 - 2 years of work experience
EXPERIENCE AND SKILLS
Fundamental understanding biopharmaceutical analytical testing, with specific emphasis on HPLC methods (including SEC, released glycans, etc), IC methods (including monosaccharides), plate based assays (included ELISA/HCP, enzymatic activity,and receptor binding)
Problem-solving and troubleshooting skills
Ability to work independently
Strong verbal and written communication skills
Strong interpersonal skills
Some knowledge of basic protein biochemical and biophysical techniques such as enzyme activity assays, receptor binding assays, cell based bioassays, ELISA, Western blot, qPCR, iCEF, CD, DSC, DLS
Experience working with CMO’s and CRO’s for methods transfer, method optimization, and data and report review
Some fundamental knowledge of cGLP/cGMP, FDA, EMA, ICH guidance’s and industry standards for analytical development and characterization of proteins
Some familiarity with the USP, EP and other compendia
Skills in statistics and statistical analyses of data a plus.
TRAVEL
10-20% of International Travel

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Control
Paid: 
Yes