A fantastic vacancy has become available for a Sr Director to join a pharmaceutical organisation in Massachusetts who are determined to develop unique ready to use cellular therapies that improve outcomes for cancer patients.
Please note that to be considered for this role you must have the right to work in this location.
- Responsible for the proper design and execution of scientific studies pertaining to process and product characterization and scale up to define suitable Target Drug Product Profile, critical quality attributes (CQAs) and assess manufacturability of phase appropriate processes.
- Approves detailed experimental protocols incorporating relevant and sensitive analytical methodologies; at the internal Process Development laboratories, and at collaborator laboratories and/or at CDMO sites.
- Leads the analysis and interpretation of results from all scientific studies and writes technical reports to support publications / presentations, quality requirements, regulatory submissions, any intellectual property filings.
- Approves technical development and transfer reports to ensure successful execution of development stage goals and objectives.
- Defines objectives, requirements and deliverables for process and analytical methodologies for activities of Research team, to permit qualification and validation of manufacturing processes and test methods.
- Serves as a subject matter expert on CMC aspects related to Dendritic Cell and T-cell biology and function; and maintains current awareness of developments and analytical methodologies in relevant scientific fields and evolution of regulatory standards.
- Represents the organisation in the scientific community; and leads data presentations and scientific discussions at scientific meetings and conferences.
- Leads recruitment and development of Process Sciences staffs to align with corporate culture and meet company goals and objectives.
- Ph.D. or Masters in biochemical engineering, cellular immunology, or related disciplines, with 10 -15 years of relevant biotechnology industry experience working in the cell therapy field.
- Strong knowledge of the process / product and analytical methods for scalable manufacture and characterization of cellular therapy products.
- Prior hands-on experiences with large scale cell isolation, cell culture, multi-parametric flow cytometry, various cellular, molecular, and immunological functional assays.
- Experiences with management of technical activities and analysis/interpretation of results to manage technical execution at external CDMO groups is required.
- Experiences in assessment of process and analytical technology platforms and requirements for qualification/validation of processes to demonstrate robustness and scalability is required.
- Prior experiences with management of cGMP manufacturing campaigns at CDMO and leading technical investigation is required.
- Detail oriented and objective data analytical abilities with excellent communication skills; and experience with writing regulatory sections for IND filings is desired.
- Ability to work independently, as well as in a collaborative environment to meet project goals with attention to detail, and with excellent written and oral communication skills.
- Enjoys solving challenging scientific questions in a fast pace, multi-disciplinary, matrixed structure within a start-up environment.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£35000 - £38000 per annum
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