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Scientist, Quality Control Molecular Analytics

Employer
Homology Medicines
Location
Bedford, MA
Start date
Apr 15, 2019

View more

Discipline
Quality, Quality Control, Science/R&D, Biology, Chemistry
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

Scientist, Quality Control Molecular Analytics
Location: Bedford, MA     

The HMI Quality Control (QC) Scientist will be responsible for supporting the analytical start-up activities (SOP writing, method qualifications, transfer, test method, protocol and report writing) for internally and externally manufactured clinical gene therapy and gene editing therapeutics. Method qualifications to include HPLC, ELISA, ddPCR, CE-SDS, Cell assays and TCID50.  We seek candidates with proven ability to work independently and collaboratively to achieve our goal of delivering products that transform the lives of our patients.

Essential Functions and Duties

  • Drafts test methods from previously developed work instructions for method types including HPLC, ELISA, ddPCR, CE-SDS, Cell assays and TCID50.
  • Works with analytical development to write phase appropriate qualification protocols or transfer protocols
  • Executes method qualifications/transfers and generates qualification reports
  • Creates equipment operational SOPs
  • Performs routine testing, reviews data, leads QC investigations, CAPAs and risk assessments
  • Trains and coaches staff and support scheduling of day-to-day analytical lab operations on the floor

Skills and Experience

  • Bachelor’s or Master’s degree in Biology, Chemistry or equivalent
  • Minimum 5 years of experience in biologics
  • Hands on experience in method development, qualification, validation and/or transfer.
  • Knowledge of quality principles and GMP, ICH and GLP regulations.
  • Hands on experience with HPLC and CE-SDS.
  • Subject matter expertise in ELISA, ddPCR and Cell based assays.
  • Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
  • Independently motivated, detail oriented and strong problem-solving ability
  • Able to work effectively in a collaborative team environment
  • Excellent communication, technical, organizational, and interpersonal skills are essential

Interested candidates should forward a cover letter and Resume / CV to careers@homologymedicines.com

Or apply online 

https://www.homologymedicines.com/careers

Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.

Company


Homology Medicines is based on groundbreaking science that harnesses the naturally occurring process of homologous recombination. This non-nuclease-based approach offers clear advantages in its precision, efficiency and on-target in vivo editing of genetic mutations. Homology obtained an exclusive worldwide license to this technology platform, which is based on the pioneering research of Saswati Chatterjee, Ph.D., Professor of Virology at the Beckman Research Institute at the City of Hope in California, member of the Recombinant DNA Advisory Committee (RAC) to the Office of the Director, National Institutes of Health (NIH) and former charter member of the Therapeutic Approaches to Genetic Diseases Study Section of the NIH. Dr. Chatterjee and her team led the first adeno-associated virus (AAV) vector-mediated gene transfer studies into human hematopoietic stem cells and subsequently identified and isolated a series of naturally-occurring AAVs from human CD34+ cells.

YEAR FOUNDED:

2015

LEADERSHIP:

Founder: Saswati Chatterjee

President and CEO: Arthur Tzianabos, Ph.D.

CSO: Albert Seymour, Ph.D.

Company info
Website
Phone
857-305-1825
Location
1 Patriot Place
Bedford
Massachusetts
01730
US

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