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QC Analytical Methods Validation Consultant (cGMP – Pharmaceutical) JD818748

JD818748

DPS is looking for an accomplished Methods Validation Project Manager to support a Biopharma client in the Boston, MA area. This individual will lead the effort in assessing existing test methods and respective validations used on site for characterization and release of drug substances and drug products. This individual will be responsible for providing recommendations to the site for improvements to the method validation and optimization of test methods and, if appropriate, revise test methods.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
01/09/2019
Days Remaining:
9
Employment Type:
Full-time
Education Level Req.:
Bachelors

QC Analytical Methods Validation Consultant (cGMP – Pharmaceutical)      JD818748

Boston, MA area

 

Summary:

 

DPS is looking for an accomplished Methods Validation Project Manager to support a Biopharma client in the Boston, MA area. This individual will lead the effort in assessing existing test methods and respective validations used on site for characteriz655358.38073ation and release of drug substances and drug products. This individual will be responsible for providing recommendations to the site for improvements to the method validation and optimiz655358.38073ation of test methods and, if appropriate, revise test methods.

 

Job Responsibilities:

  • Provide recommendations to the development, optimiz655358.38073ation and qualification of existing test methods for characteriz655358.38073ation and release of drug products, APIs, and raw materials using HPLC, GC, KF, TOC, CAD, and ELSD.
  • Present identified deficiencies cross-functionally to Quality Control, Manufacturing, Validation, Regulatory and others as appropriate.
  • Revise test methods to reflect validation if appropriate.
  • Serve as Subject Matter Expert in technical meetings regarding method validation issues or concerns.
  • Provide documented assessments of impact to product, patient or processes in the event of identified method validation deficiencies or concerns.

 

Qualifications:

  • Bachelor of Science degree in a relevant scientific discipline (Chemistry, Biochemistry, Biophysics, Chemical Engineering) and a minimum of 6 years of laboratory and/or industry experience OR
  • Master of Science degree in a relevant scientific discipline and a minimum of 4 years of laboratory and/or industry experience.
  • Working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable.
  • Demonstrated knowledge and understanding of lifecycle management and quality-by-design principles for analytical methods.
  • Analytical development experience and knowledge (i.e. HPLC, GC, CAD, ELSD, DLS, and wet chemistry techniques). Experience with mass spec and lipid-based parenteral formulations are both highly desirable.
  • Preferred hands-on experience and scientific knowledge with liposomal formulation, implementing the key technologies for drug-loaded liposome manufacturing and purification: membrane extrusion technology, gradient-based drug loading technology, and tangential flow filtration (TFF) technology.
  • Proven track record of independent design and execution of laboratory studies for pharmaceutical products and processes and in-depth troubleshooting abilities.
  • Working knowledge of cGMP guidelines from FDA, EMA, EDQM, and ICH.
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