QC Methods Validation Project Manager (cGMP – Pharmaceutical) JD817726 - Boston, MA | Biospace
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QC Methods Validation Project Manager (cGMP – Pharmaceutical) JD817726

DPS Engineering

Location:
Boston, MA
Posted Date:
8/11/2017
Position Type:
Full time
Job Code:
JD817726
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Assay Development, HPLC, Project Management, Project Manager, QC, Quality Control, Scientist,

Job Description

QC Methods Validation Project Manager (cGMP – Pharmaceutical)      JD817726
Boston, MA area

Summary:

DPS Engineering is looking for an accomplished Methods Validation Project Manager to support a Biopharma client in the Boston, MA area. This individual will be instrumental in managing a project to ensure QC methods and practices meet current industry standards and will be enlisted to bring client’s program in line with best practices and standards.

Job Responsibilities:
•   Prepare method qualification/validation protocols and reports according to ICH, USP and other regulatory guidelines for various analytical methods for the characterization of biopharmaceutical protein products and raw materials.
•   Guide and help laboratory analysts during the method validation, method qualification, method transfer, and platform method verification and evaluation activities in QC department.
•   Serve as technical lead for data analysis including appropriate statistical application as required.
•   Draft and review analytical method related protocols, SOPs, reports and other documentation to support ongoing activities in the QC laboratory.
•   Support the training of new and existing laboratory personnel for Analytical methods including Bioassays.
•   Perform and evaluates technology transfers associated with new products or processes to QC laboratory.
•   Participate during the technical discussions between the company team members and clients related to analytical methods.

Requirements

Qualifications:
•   Must have background in Life Sciences/Chemistry with 8+ years of industry experience in method validation and method transfer.
•   Masters or Higher degree and laboratory experience dealing with Method validation is preferred.
•   Working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable.
•   Demonstrated expertise with a range of protein/glycoprotein analytical techniques including ELISA, HPLC/UPLC, enzymatic, and electrophoretic (SDS-PAGE, Western blots, IEF and CE) procedures. Cell culture and bioassay/potency assay experience is also a plus.
•   Reasonable knowledge and understanding of overall maintenance, calibration, and qualification of the QC laboratory analytical equipment.
•   Working knowledge of ICH, ISO and GMP regulatory compliance requirements related to product stability testing is plus.