Associate Director / Senior Principal Scientist

The Associate Director / Senior Principal Scientist will serve as the purification/downstream Subject Matter Expert (SME) for biologics drug substance manufacturing. This remote role is heavily focused on late-stage process development, leading process characterization (PC), and driving Process Performance Qualification (PPQ) activities. The successful candidate will also play a pivotal role in authoring and supporting Biologics License Applications (BLAs) and will actively oversee and collaborate with external Contract Development and Manufacturing Organizations (CDMOs).

Principal Duties and Responsibilities include the following:

• 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.

Supervisory Responsibilities:
Direct reports: NA
Indirect Reports: supervise CDMO, CRO and external resources (i.e. consultants)

Qualification Requirements:

Education:

• 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.

Experience:

• 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.

Knowledge/Skill:

• 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.

Working Conditions:
Specify work environment:

• 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.