Analytical Development – Quality Control Manager –6519-ASH

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a AD/QC Manager  for a 12 months contract based in Basel.

 

Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

 

Main Responsibilities:

  •  Responsible for Analytical Development and Quality control for assigned CMC program in late stage development (typically phase 3 and commercial). 
  • Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .
  • Point of contact and supervision for analytical 3rd parties’ labs, e.g., CMOs and CROs, for defined analytical tasks.
  • Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
  • Representation of AD/QC in technical project team and CMC team meetings.
  • Oversight for release, retest, stability studies, transfer and validation analyses conducted by analytical service providers.
  • Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records.
  • Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
  • Write-up and review of analytical protocols and reports and establish specifications.
  • Drafting and review of applicable CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
  • Independently reviews scientific work in project related activities.
  • Independent evaluation and development of novel analytical techniques and instrumentation as applicable at 3rd parties.
  • Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management. 
  • Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings.
  • Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
  •  For the assigned analytical function, set and accomplish product development timelines working closely with the relevant Technical Project Leads (DS/DP/IDD).
  •  Responsible for the analytical expertise for assigned program drug substances, drug products and/or Integrated Drug Device.
  •  Summarizing, defending and communicating results and product quality issues to management.
  • Manage the applicable outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.
  • Participate in technology transfer between laboratories, both internal and external to the company.

 

Qualifications and Experience:

 

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  • College-, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry.
  •  In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.
  • Personality and disposition to manage professionals effectively in a matrix system. Diligent attention to details. Willingness to limited travel. Mature stable person with a positive and dynamic demeanor. High flexibility, superior communication, time-management and team-working skills. Ability to work independently and to take initiative. Proficient in English. Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
  • Ability to complete assignments, meeting quality- and time-oriented objectives.
  • Strong skills in timeline development and management.
  • Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams of people with multiple perspectives, culture and talents, capable of functioning as individual contributor or team leader.
  • Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development. Experience in the development and performance of analytical tests for a variety of drug substances and products.

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