QC Scientist I, Molecular BiologyLocation: Bedford, MA
The HMI Quality Control (QC) Scientist will be responsible for leading and supporting the management of Homologys analytical method lifecycle including but not limited to method qualification, transfer, validation, performance monitoring and continuous improvement. The individual will work cross-functionally to support on-going GMP operations of a Clinical Phase 1/2 manufacturing facility.
. Essential Functions and Duties
Skills and Experience
- Independently lead and support the optimization, qualification, transfer, validation, and verification of GMP analytical methods including but not limited to ddPCR, ELISA, HPLC, Capillary electrophoresis, (CE-SDS), Cell-based Assays (e.g. TCID50, Gene expression and Potency).
- Writes/execute protocols and generate reports related to QC Method transfer, validation, and verification activities.
- Support monitoring of on-going analytical method performance (e.g. system suitability trending) to drive continued improvement and optimization of HMIs analytical methods.
- Assist with data trending of assay controls and reference standards, as needed.
- Lead and support atypical and out-of-specification (OOS) investigations, as needed.
- Author and own critical quality systems (CAPA and Change Control) in support of analytical method lifecycle, as needed.
- Lead and support analytical method troubleshooting, as needed.
- Partners with internal and cross-functional departments (e.g. AD, Internal QA, External QA) to ensure success of analytical services program.
- Presents to cross-functional teams and effectively communicate critical analytical issues and solutions.
- Mentor and coach junior team members
Degree in Biology, Chemistry or equivalent
8 years of related experience with a Bachelors Degree; or 6 years of experience and a Masters Degree; or PhD with 3 years of experience; or equivalent experience.
Independently motivated, detail oriented and strong problem-solving ability
Hands on experience in method development, qualification, validation and/or transfer.
Knowledge of quality principles and GMP, ICH and GLP regulations.
Subject matter expertise in ELISA, ddPCR and Cell based assays.
Hands on experience with HPLC and CE-SDS.
Experience creating/revising/reviewing operational SOPs, technical documents, protocols, and reports.
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 firstname.lastname@example.org
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.