Manufacturing Science and Technology Leadership Role
7 days ago
We are seeking an experienced Associate Director, Manufacturing Science and Technology to lead our technology transfer efforts. This role will be responsible for transitioning manufacturing processes from development to production both internally and externally.
Job DescriptionThe successful candidate will have a strong background in process development, MSAT or manufacturing, with 14+ years of experience. A Bachelor's Degree in Biomedical Engineering or a related field is required, with a Master's or Ph.D. preferred.
Main Responsibilities:- Lead technology transfer of manufacturing processes to internal and external groups
- Collaborate with Process Development and Manufacturing to author and review SOPs, Batch Records, CAPAs, Investigations and Deviations
- Design and review experimental plans, analyze and summarize data, author technical reports, define and implement recommendations for process optimization
- Contribute to CMC sections of INDs, BLAs, and other regulatory documents for FDA and other international regulatory agencies
Shoreline Biosciences, Inc. is a leading biotechnology company focused on developing safe, effective, and accessible allogeneic NK and macrophage cell therapies. Our team is committed to delivering high-quality products and services to patients and families living with cancer.
Requirements:- Bachelor's Degree in Biomedical Engineering or a related field, with a Master's or Ph.D. preferred
- 14+ years of experience in process development, MSAT or manufacturing
- Strong leadership skills and strategic problem-solving ability
- Excellent written and verbal communication skills
The anticipated salary range for this position is $108,000 to $203,000. The final salary offered will depend on the candidate's experience, qualifications, geographic location, and other job-related factors. Additionally, the hired candidate will be eligible to receive an annual bonus and an equity grant.
Work EnvironmentThis position requires working with cells and cell lines of human and/or animal origin, as well as hazardous materials. The regular requirements of an office environment apply when not working in or around a laboratory environment. 100% on-site work at corporate headquarters in San Diego, CA is required, with occasional evening and weekend work.
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