Associate Director, Process Development
Our client is a biotechnology company. They have asked us to assist them in a search for an Associate Director, Process Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Manages, develops, and motivates an effective Process Development team.
- Acts as a leader in the area of autologous cell therapy process development.
- Leads and executes process development project strategies with cross-functional and external collaboration.
- Leads and executes laboratory studies for development, optimization, and manufacturing of CAR-macrophage or other cell product therapies including design, planning, execution, analysis, and reporting.
- Writes, maintains, and reviews laboratory notebooks and logbooks.
- Leads activities to define, develop, and transfer processes to cGMP manufacturing partners or internal sites.
- Oversees and collaborates in the development and application of new analytical methods and technologies for process optimization.
- Authors and reviews protocols, technical reports, regulatory documents, and memos to summarize experiments and investigations.
- Authors and reviews CMC sections for regulatory submissions (e.g. IND, BLA) in collaboration with other areas.
- Collaborates with internal and external partners to evaluate and implement new process technologies to develop next generation processes.
- Interacts with internal cross-functional team members including manufacturing, nonclinical, clinical, QA, regulatory, legal, and discovery teams.
- Works effectively in a team environment while contributing individually and through team management to meet project timelines and objectives.
- Travels domestically as needed.
- A degree in chemical or bioengineering, cell biology, immunology, or related discipline is required.
- If only a Bachelor’s Degree is held, 10 years of relevant experience is required. If a Master’s Degree is held, 8 years of relevant experience is required, and if a PhD is held, 5 years of relevant experience is required.
- Must have experience in design, optimization, scale-up, process control, and technology transfer of cell therapy unit operations such as: apheresis and cell collection, cell selection techniques and automation technologies, primary and mammalian cell culture using closed system and automated culture technologies, genetic modification and protein expression techniques, cell washing, formulation, and cryopreservation.
- Demonstrated success leading technology transfer activities for GMP manufacturing to internal or external sites is required.
- Requires proficiency performing flow cytometry assays.
- Must have hands on experience with other analytical methods typically used in the manufacturing and characterization of biological products or cell therapies.
- Experience writing regulatory submissions, technical reports, protocols, and laboratory notebooks is required.
- Must have the proven ability to thrive in a collaborative team environment.
- Strong oral and written communication skills, interpersonal skills, adaptability, and a positive attitude are required.
- Must have proficiency with statistical methods for data analysis (e.g., JMP, GraphPad Prism).
- 2 years of direct management experience is a plus.
- Previous experience in late stage process development and regulatory filings in the biopharmaceutical industry is preferred.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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