Analytical Development

An Analytical Development – Quality Control Manager is required to join a Swiss based pharmaceutical company on a contract basis. Based near Basel, this is a hybrid role with a requirement to work onsite 3 days per week.

The QC Manager will deal with the analytical development of Drug Substances and Drug Products and will ensure that all products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

Role Responsibilities:

• Responsible for Analytical Development and Quality control for assigned CMC program in late stage development (typically phase III 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.
• Oversight for release, retest, stability studies, transfer and validation analyses conducted by analytical service providers.
• 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.
• Support 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

Candidate Specification:

• Experience interacting with regulatory agencies and responding to analytical queries is a plus.
• Strong understanding of analytical CMC requirements, including generation and review of data packages to support quality section of regulatory submission.
• 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.
• 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