Senior QC Scientist - Analytical Method Development - Contract - Lexington, MA
Proclinical is seeking a Senior QC Scientist specializing in Analytical Method Development.
Primary Responsibilities:
The successful candidate will transfer and validate next-generation analytical procedures for testing viral vectors, cell banks, and gene therapy products. They will collaborate with external partners and internal teams to support clinical and commercial product pipelines, ensuring compliance with regulatory guidelines.
Skills & Requirements:
- BS in Chemistry/Biochemistry or related science.
- Experience in analytical laboratory settings, particularly with method validation and transfer.
- Understanding of industry testing requirements and standards.
- Excellent time management and organizational skills.
- Ability to work under pressure and manage changing priorities.
- Familiarity with FDA and EMA guidance documents.
Core competencies:
- Computer literacy (MS Word, Excel, and LIMS).
- Good/effective communication and organizational skills with the ability to work well with others and independently.
- Ability to work collaboratively with cross-functional departments.
The Senior QC Scientist - Analytical Method Development's responsibilities will be:
- Transfer and validate analytical methods for cGMP production.
- Author protocols and reports related to QC method transfer and validation.
- Support document generation for application filings.
- Perform statistical analyses during method validation studies.
- Monitor analytical method performance and system suitability.
- Assist with data trending and compile trend reports.
- Present findings to cross-functional teams and communicate solutions.
- Maintain subject matter expertise in gene therapeutic product quality methods.
- Ensure laboratory procedures are current and facilitate updates.
- Complete documentation in line with cGMP standards.
- Maintain QC lab compliance with industry standards.
- Troubleshoot analytical testing methods as needed.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
