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Analytical Development Manager

Req ID:  3232
Date: 
Location: 

LEON (GENHELIX), Madrid, ES

Business Unit:  Mabxience

Role: Analytical Development Manager

Employee:

 

Department: RD

Company/Business Unit: mAbxience

Reporting to: Head of R&D/R&D Operation Manager

Number of reportings:15-20

Vacancy Location: León

Reporting Locations: León

 

Date: January 2020

Global Responsibility

Lead and coordinate the development, qualification and preparation for validation of new physicochemical and bioanalytical methods, sample testing to support process and formulation development and other analytical developments activities of biotherapeutics drug candidates at all stages of development. Review of external development and qualification & validation reports. Present and interpret scientific data, write technical reports and represent the team in matrix team or R&D group meetings when needed. Keep fluent interaction with QC Unit in order to assure effective implementation of relevant analytical methods under GMP environment to support next stages of product development.

Specific Responsibilities

  • Identifies analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug candidate formulation development. 
  • Applies scientifically-driven thinking to the development of scientifically sound, well understood, and robust analytical methods. 
  • Coordinates with other internal departments to review/approve qualification/validation of analytical methods. 
  • Leads analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories. 
  • Develop phaseappropriate quality control strategy for drug substance and drug product.
  • Manage product stability study programs. 
  • Leads development of scientifically sound and data driven specifications.  
  • Oversees analytical activities including the review and approval of test records, forms, methods, protocols and reports. 
  • Prepares and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions. 
  • Participate in drafting and reviewing of Module 3 for NDA and other regulatory filings as required 
  • Lead and coordinate the work of Scientists, Technicians and Analysts within the Analytical development group.
  • Review internal and external analytical results and ensure of their quality.
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  • Proactively participate in support activities for process development and process changes.
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  • Organize and interpret scientific data. Review and check analytical data generated by peers and maintain integrity of data.
  • Document analytical activities and results accurately, in a timely manner and right-first time.
  • Communicate effectively with peers, supervisor and management about the status of the assigned activities, maintaining their superior constantly updated.
  • Write and review technical and data analysis reports, SOPs, Tech Transfer documents and maintain accurate, precise and legible documentation.

 

Requirements and personal skills

  • Education: minimum Master’s Degree in Chemistry, Biochemistry, Bioengineering or similar. PhD will be preferred.
  • Languages: Fluent in English as well as Spanish, knowledge of other languages will be an asset.
  • Experience (years/area): +10 years of relevant experience in biopharmaceutical/biotechnology industry. +5 years of relevant experience in Biosimilars product development. Expertise in Mass Spectrometry of peptides and proteins. Hands-on experience and expertise in analytical methods such as size-exclusion, ion exchange, reverse and normal phase HPLC, CE technique like iCIEF, CE-SDS, UV/VIS and fluorescent spectroscopy and other related protein characterization techniques. Expertise in post translational modifications of proteins and peptides. Expertise in protein separation and enrichment sciences, protein aggregation, and protein structure and folding.
  • Specific Knowledge: Knowledge of biologics and industry experience in biologics research/development. Updated knowledge on FDA/ICH guidance’s and national Pharmacopoeias is preferred.
  • Travels: Not required.
  • Personal skills: Demonstrate good leadership in managing the assigned resources; able to deliver results in a fast-paced environment; able to work independently and collaborate with other groups of the R&D and Company organization and deliver results in line with project and team objectives.

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