Quality Control Project Lead
ROLE OVERVIEW and RESPONSIBILITIES
We invite an experienced analytical scientist to join the Quality Control Project Lead team. The key mission of the QC Project Lead Team is to serve as a point of contact for Quality Control analytical aspects for Ichnos Sciences development Phase I/II programs. The successful candidate will support analytical activities, be accountable for QC project deliverables and be the interface between QC and internal-, external- clients like regulatory affairs, discovery, process sciences, MSAT, QA and CMO/CRO. This role is part of Ichnos CMC matrix organization and contribute to overall Ichnos programs objectives.
In this role, your main responsibilities will include the following:
- Act as QC project manager by coordinating analytical project activities:
- Actively participate in CMC project team meetings as assigned and represent QC function.
- Communicate timelines (e.g. internal analytical method transfer or validation) and project changes/updates to QC laboratory (track actions, prepare meeting agendas and minutes).
- Communicate consolidated QC plan and analytical strategy to CMC project team.
- Be accountable for QC project deliverables like product specifications, external testings and analytical work packages.
- Lead external analytical method transfer to CMO/CROs.
- Identify risks and critical activities and develop risk mitigation plans in collaboration with key stakeholders.
- Provide guidance, technical support expertise to ensure that manufactured products are tested as per applicable regulatory standard and guidelines.
- Author, update, and revise CMC regulatory dossier sections to support regulatory filings.
- Execute technical review of analytical data/documentation as required.
- Participate in program due diligence as required.
EDUCATION AND DESIRED EXPERIENCE:
- Master/PhD/bachelor’s degree in chemistry, Biology, Biochemistry or related scientific disciplines.
- Minimum 3 to 5 years’ project management experience in biotechnology industry and under cGMP standards.
- CMO/CRO experience is a plus.
- Must have a good understanding of a variety of analytical techniques such as HPLC, ELISA assays, capillary electrophoresis, and other analytical techniques applicable for monoclonal antibody/bi/trispecific type molecules
- Knowledge of analytical method development, validation, and transfer.
- Knowledge/awareness of guidelines and regulations (EU, USP, ICH…)
- Strong diplomacy and excellent communication skills, both written and verbal in English; French is a plus.
- Client/Team-oriented, excellent organization skills, ability to work independently and hands-on approach to work.
- Ability to work in a changing and demanding environment.
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint…