Beschreibung
Our client, pharmaceutical company basedin French part of Switzerland, has a new opportunity to join a dynamic team to support quality control activities in the development stage for biological products.
This is initially 6 months fixed term contract, with possibility to extend.
Daily tasks:
- Manage the development, validation and transfer of analytical test methods, specification setting and stability programs for clinical, late stage biologics product development in accordance with ICH/FDA/EMA/USP/Ph. Eur. or relevant guidelines
- Develop and lead internal analytical technology transfer of projects into the Quality Control department, and external analytical transfer of projects to CMO/CROs.
- Interface with other clients (Regulatory Affairs, Discovery, Process Sciences, MSAT, QC, QA, CMO/CRO etc.) as necessary.
- Participate in CQA identification, and perform FMEA analysis with respect to analytics.
- Execute technical review of analytical data, and laboratory documentation, method validation protocols, method validation summary reports, method development reports, and similarity/comparability assessments.
- Author, update, and revise CMC regulatory filing sections to support regulatory filings as required.
- Ensure compliance with cGMP such that the products are assessed to agreed-upon specifications in a timely manner in order to support in-process, lot release and stability testing
- Perform deviation investigations and CAPA implementation in support of CMC QC projects and improvement as required
- Champion, lead or participate in continuous improvement activities.
- Track action items, prepare meeting agendas, coordinate activities and disseminate project information.
- Perform similarity assessments for biosimilars as required.
EDUCATION AND DESIRED EXPERIENCE
- PhD or equivalent immunology, biochemical engineering, biochemistry, biology or related discipline
- Minimum of 5 years biologics experience in an industrial setting under GMP standards; CMO experience is a plus
- Relevant Process and QC experience and knowledge of current early and late stage analytical techniques including for process characterization/validation.
- Excellent communication skills and strong diplomacy skills required.
- Strong knowledge/awareness of FDA, ICH, and USP guidance and regulations.
- Knowledgeable in US and EU CMC Analytics requirements for submission (for IND, IMPD, BLA etc.)
- Fluency in English, both written and verbal; French is a plus.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.