- Lead and manage purification process development, scale-up, and technology transfer projects from lab-scale to commercial manufacturing of antibody-based molecules.
- Design, optimize, and troubleshoot downstream purification processes to improve efficiency, yield, and product quality.
- Develop and implement robust purification process control strategies tailored to the unique characteristics of antibody molecules, such as ADCs and fusion proteins, ensuring consistent and reliable manufacturing operations that are suitable for technology transfer to CDMOs for GMP clinical manufacturing and process validation.
- Utilize statistical tools such as JMP and design of experiments (DOE) for process optimization and characterization of purification processes.
- Collaborate cross-functionally with research, development, manufacturing, quality and CDMOs/vendors to achieve project goals and timelines related to purification development and operations.
- Provide technical expertise, guidance and leadership to junior team members, fostering their professional development.
- Stay current with industry trends, regulatory requirements, and emerging technologies in purification.
- Drive continuous improvement initiatives to enhance purification process efficiency, scalability, and cost-effectiveness.
- Participate in technology evaluations and assessments for purification process improvements, new equipment acquisitions and CDMO selection criteria.
- Ensure compliance with relevant regulatory guidelines and quality standards throughout all stages of purification process development and manufacturing.
- Master's degree or Ph.D. in Chemical Engineering, Biochemistry, or related field.
- 7-10 years of hands-on experience in purification process development, scale-up, and technology transfer within the biopharmaceutical industry, with a specific focus on antibody-based molecules. Experience in ADCs and fusion proteins is highly preferred.
- Proven track record of successfully leading and managing purification process projects from conception to commercialization. Late-stage development and process characterization experience is highly preferred.
- In-depth knowledge of downstream purification techniques, including chromatography, filtration, and viral clearance.
- Strong analytical and problem-solving skills with the ability to utilize statistical tools such as JMP and design of experiments (DOE) to optimize purification processes.
- Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams.
- Experience with purification process characterization, validation, and regulatory submissions is highly desirable.
- Demonstrated leadership capabilities and the ability to mentor and develop junior team members.
- Detail-oriented with a commitment to quality, compliance, and safety in all aspects of work.
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Senior Scientist/Senior Manager Downstream Purification - Gaithersburg, United States - Salubris Biotherapeutics Inc
Description
Job Description
Job DescriptionCompany OverviewSalubris Biotherapeutics, Inc. (or SalubrisBio) is a science-driven biotechnology company dedicated to the discovery and global development of novel antibody therapeutics for the treatment of cancer, cardiovascular and metabolic diseases. We strive to develop novel therapeutic molecules that provide clinically meaningful improvements in disease burden and quality of life to patients with significant medical needs.
Role Summary
We are seeking a highly skilled and experienced Senior Scientist/Senior Manager for Downstream Purification to join our dynamic team. The successful candidate will play a crucial role in leading drug substance purification process development, scale-up, and technology transfer activities for the pipeline molecules, contributing to the successful manufacturing of biopharmaceutical products, with a specific expertise and focus on antibody-based molecules including antibody-drug conjugates (ADCs), bispecific antibodies and fusion proteins.
The position is based in Gaithersburg, MD.
Job Responsibilities
