• Serve as the in-house downstream SME, guiding CDMO for late-stage downstream process development, optimization, and scale-up.
• Lead downstream process characterization and PPQ activities for biological drug substances to ensure robust, scalable, and compliant commercial manufacturing.
• Manage technology transfer and manufacturing operations with external CDMOs, acting as the primary downstream technical liaison for CDMO partners.
• Author, review, and approve technical and scientific documents to support regulatory submissions, with a heavy emphasis on IND and BLA preparations.
• Design and oversee viral clearance, impurity clearance, concurrent validation studies and strategies to support regulatory requirements.

• A Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field with 6-8 years of experience. Or a M.S. with 10-12+ years of experience in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field.

• Minimum of 6–8 years of experience as a downstream SME in the biopharmaceutical or biotechnology industry, focused on process development and manufacturing of biological drug substances, with a strong preference for experience in antibody‑based therapeutics
• Demonstrated experience in downstream process development, late-stage process characterization, scale-up, technology transfer, and process validation (PPQ) for biological drug substances.
• Experience managing CROs and CDMOs; proven experience working directly with Chinese CDMOs is a strong bonus.
• Proven track record in authoring technical and scientific documents for regulatory submissions
• Expert knowledge of advanced principles, concepts, and theory related to downstream process development, with a bonus for direct experience in viral clearance validation and small scale and large scale resin life validation.
• Extensive knowledge of cGMP/GLP ICH, FDA, and EMA guidelines.
• Experience in INDs and BLAs submissions is highly preferred.

• Candidates proficient in both English and Mandarin are highly encouraged to apply.
• Excellent leadership, organizational, and project management skills.
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
• Outstanding communication and collaboration skills within cross-functional teams and external organizations.
• Ability to work in a fast-paced virtual environment.
• Flexibility to travel domestically and internationally as required
• Excellent leadership, organizational and project management skills.

• This is a mainly a remote role requiring the ability to function effectively in a virtual office environment. Traveling to the Company headquarters in Fort Lauderdale, FL may be required.
• Willing to participate in early morning or late night meetings with CDMOs in China
• Domestic and international travel up to 25%
• Regularly required to stand, sit, talk, hear, and use hands
• Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:  $165-200K

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.