ProClinical is pleased to advertise a vacancy for a Senior Consultant with an independent biotechnology company. This company, which prides itself on its pioneering immunotherapy expertise, is seeking for the Senior Consultant to join the company's London-based team on a contract basis.
The Senior Consultant will support early development pipeline products in relation to Chemistry Manufacturing and Controls (CMC) activities in a new spin-out focused on bispecific nanobodies. The candidate needs to be capable of independently handling the full CMC development package including analytical method development and validation of the finished product, manufacturing of clinical trial material and IMPd/IND submission.
- Developing and owning a detailed roadmap for the scientific development path for manufacturing process optimisation, robustness, and reliability. This include process scale up, shelf-life extension, stability studies, etc., by progressing the process science.
- Ensuring that the rationale behind the manufacturing process is well established, robust, meets regulatory requirements, and is commercially viable at full production scale.
- Closely interacting with multiple functions to create high quality regulatory submissions that support product development strategy.
- Ensuring the timely delivery of high-quality CMC documents including, regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA /MAA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
- Facilitating the development of reviews and comments on all technically complex CMC documentation for submission to regulatory authorities, including process development, process validation, analytical method development, and analytical method validation.
- Articulating complex Regulatory CMC issues to the leadership team and external stakeholders to support global development and commercialisation of drug candidates.
- Evaluating proposed manufacturing and quality changes for impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes.
- Managing interactions with MHRA/EMA/FDA and other regulatory authorities for portfolio programmes to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, and amendments/supplements/variations.
- Supporting Quality Assurance in preparing and hosting regulatory inspections.
- Ensuring that all documentation from CMO/CROs is reviewed and stored as appropriate within the QMS.
- Ensuring the team has the technical skills and training to diagnose, rectifying process development issues, manufacturing NCRs/deviations, and responding quickly and effectively to maintain material supply.
- Ensuring the team has appropriate resource for the development, optimization, validation and GMP hardening for biological function/potency assays to move them from the R&D team to the in-house QC team.
- Ensuring all data/reports generated by the team are to appropriate quality and regulatory standard for compilation into CMC submission and meet submission deadlines.
- Ensuring that the manufacturing process is robust, meets regulatory requirements and is commercially viable at full production scale.
- Assuring that the Company is at the forefront of CMC developments for ATMP's
- Influencing and guiding the regulators for ATMP's
- Transferring the manufacturing processes in a compliant manner from the CMO's
Skills and Requirements:
- A PhD in biological science, engineering, or related area.
- At least 3 years of hands-on aseptic manufacturing development experience, preferably in ATMPs.
- A strong background in process development.
- Demonstrable experience with manufacturing ATMPs for clinical trials and establishing a manufacturing function.
- Excellent interpersonal skills, including communication, leadership, management, and influencing.
- A strong understanding of Quality Management Systems and proactive approach to resolving deviations and CAPAs.
- A strong understanding of lean manufacturing principles.
- Strong CMC technical and working knowledge/experience is required in biologics or ATMP's.
- Demonstrable experience in CMC/Quality aspects for development of investigational products with Fast Track designation.
- Experience in managing significant change.
- Good understanding of Quality Assurance and Regulatory Affairs.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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