Quality Recruiting. Established Experts.
Director/Senior Director, Process Development
Reference Number: 3909
Location: MA
Our client is an immuno-oncology biotechnology company. They have asked us to assist them in their search for a Director/Senior Director, Process Development.
Major tasks and responsibilities will include:
- Evaluates next generation technologies and equipment for closed system clinical scale manufacturing of autologous cellular therapy products.
- Works collaboratively and cross-functionally with the vector process development and analytics groups to develop alternative methods for transduction of autologous T cells with retroviral or lentiviral vectors
- Designs, generates, analyzes, and interprets experimental data from in vitro, primary human cell based assays to inform process development in the optimization of manufacturing our autologous cell based immunotherapy.
- Troubleshoots and solves difficult problems associated with patient to patient variability.
- Works closely with colleagues to translate R&D concepts into clinical development programs.
- Communicates and presents scientific findings at group and company meetings.
- Influences corporate CMC strategy and goals.
- Collaborates with QA/QC to ensure regulatory compliance.
- Collaborates with Legal/IP to protect scientific advancements.
- Maintains detailed experimental records and laboratory notebook.
- Plays a key role in partnership with relevant academic partners.
- Assesses global regulatory authority’s guidance for cell therapy R&D and commercialization. Play a key role in communicating with regulatory bodies.
We seek candidates with the following qualifications:
- Master’s degree required, PhD highly preferred.
- Must have relevant industry experience. Experience with immunology, oncology and/or immuno-oncology highly preferred.
- Requires experience leading process development activities with cell and gene therapies, and experience advancing therapies from discovery to clinical development.
- Demonstrated competence in mammalian cell/tissue culture techniques and flow cytometry, and in the execution of primary T-cell based assays such as activation, proliferation, cytotoxicity and cytokine release highly preferred.
- Must have experience performing cell-based assays across multiple assay platforms, and making/using viral vectors.
- Experience with cell therapy processing equipment such as Elutra, Cell Saver Elite, Sepax, Prodigy, CliniMACS, Wave Bioreactors, and LOVO are a plus.
- Requires outstanding written and oral communication skills and the ability to work collaboratively.
If interested, please email your resume as a Word attachment to us, reference 3909. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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Christopher is highly professional, energetic and efficient. He knows the pharmaceutical industry and was great at understanding my needs...
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Dan… Now that I interacted with several head hunters, I think it is easy for me to say you are the best. You are sincere in finding a perfect match rather than making numbers and you do a very good job selling the truth about the position to the candidate and prepare the candidate for the interview. So keep doing what you do, you are very good at it.
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Jan is a true partner in the talent acquisition business. She is genuinely interested in making certain her clients are positioned to ensure long-term success for both parties. As a candidate, in preparation for the interview process, Jan was quickly able to provide me information about the position, the company, their culture, and key leadership profiles, ensuring I could best represent myself and critical skills and experiences that I brought to the table. Jan made sure all of my questions were immediately answered with quick and responsive communication. After accepting the position, Jan and I remain in contact today and she is always available to provide continued support and employment advice. She now provides me with recruiting assistance for my department and continues to remain true to form in assisting in the process on the employer’s side, while identifying the best talent for our needs.
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Dan, I want to thank you for the work you have done with me for this position. It has been a great pleasure working with you. I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever. And this is independent of the happy conclusion that should happen shortly with the signature of the offer letter. If someone needs an excellent professional in your field, your name will be at the top of my list.
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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Jan recruited me to my current position and always conducted herself in the most professional manner. She was a pleasure to work with through a time of transition. I highly recommend Jan.
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