Senior Manager of Quality Control, CMC

The Senior Manager of Quality Control will oversee day-to-day QC operations to ensure timely testing and release of raw materials, drug substance, and drug product in compliance with GMP and regulatory requirements. This role manages analytical and microbiological testing, stability programs for drug substance and drug product while supporting formulation discovery and development.

Principal Duties and Responsibilities include the following:

• Review and manage QC related documents
• Manage batch release test records
• Manage stability programs, including stability protocols, stability testing records, managing and analyzing stability data to derive stability trends, support shelf-life and specification development.
• Assist the Quality department in release and stability deviations, OOS, investigations and justification of shelf-life extensions
• Manage reference standard programs (inventory, bridging and qualification)
• Assist Formulation Discovery with the collection and analysis of non-GMP analytical data
• Manage environmental monitoring and microbiological controls for GMP facilities
• Manage the testing of compendial methods of release testing of GMP lots of drug substance and drug products.
• Foster collaboration with cross-functional groups including Formulation Discovery, Drug Substance Manufacturing, Drug Product Manufacturing, Quality, and Regulatory Affairs.
• Ensure adherence to GMP, ICH, and FDA guidelines for QC activities.

Supervisory Responsibilities:

• Indirect Reports: supervise CDMO, CTL, and external resources (such as consultants)

Qualification Requirements:

Education:

• M.S. or B.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.

Experience:

• Must have 5+ years of pharmaceutical or biotechnology industry experience specializing in quality control or analytical development.
• Must have working knowledge of cGMP, ICH, and regulatory guidelines.
• Must have hands-on experience managing global CTLs and CDMOs.
• Must have strong technical experience in at least one of the modalities: monoclonal antibody and/ or oligonucleotide.
• Must have experience in QC activities, such as stability program and GMP document review.
• Good to have skills in statistics analysis and software (such as JMP).
• Good to have experience in complex drug products, such as co-formulation, multi-components, conjugates, etc.
• Good to have experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings.
• Good to have late phase experience, such as PPQ and commercialization.
• Ability to work in a fast-paced virtual environment.
• Flexibility to travel domestically and internationally as required.
• Excellent communication, leadership, organizational and project management skills.

Working Conditions:

1. Specify work environment:

• Work from home.
• 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: $155,000-185,000

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

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