quality control chemist - iv.

job summary:
Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV group. This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.

 
location: Bothell, Washington
job type: Contract
salary: $54.00 - 55.96 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
- Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).

- Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods.

- Plan and track method transfer and/or method validation deliverables.

- Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps.

- Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis

- Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals.

ORGANIZATIONAL RELATIONSHIPS

- QCSV-Portfolio

- PGS

- Analytical R&D

 
qualifications:
- Bachelor's degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline

- 8-10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required

TECHNICAL SKILLS REQUIREMENTS

- Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re-validation, co-validation, and cross-validation.

- Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.

- Expert knowledge of scientific principles and expertise of mAb, ADC, vaccine, gene therapy, able to design and evaluate the design of study/experiment.

- Have good mindset and technical skills of analytical methods and plate-based methods. Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS ) are preferred but not required.

- Good project management skills and experience managing multiple projects at the same time is essential

- Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement

- Understand of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc.

#LI-CV1

 
skills: Project Management, Biology, Quality Control (QC), Investigational New Drug (IND), Biologics License Application (BLA), International Council for Harmonization (ICH), Investigational Medicinal Product Dossier (IMPD)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.