CMC Specialist

This is an opportunity to join a strong team and immediately have an impact on the development of new pharmaceutical drugs.  You will be involved in early and late-stage drug development with direct oversight of development and control of the full supply chain for drug substance and drug products. In addition, you will be responsible for reviewing and approving relevant SOPs, while also serving as a subject matter expert supporting the Company’s QMS. This position will report to the COO but will be integrated into the Company’s cross-functional Research and Development team.

Humanetics is a privately held, clinical-stage pharmaceutical company engaged in the discovery and development of proprietary pharmaceutical candidates. The Company is currently focused on the development of its leading drug candidate BIO 300 as a first-in-class radiation modulator with applications in biodefense, oncology and inflammatory lung diseases. The Company has significant federal government contracts which funds its research/development and operations and relies on CDMOs for manufacturing activities.

Position Description: Responsible for the development and control of the entire drug substance and drug product supply chain. Responsible for all CMC activities, including management of third-party manufacturing partners, and for development of required regulatory documentation.  Plays a significant role in managing government funded research projects and supporting regulatory approval efforts.

Reports to: Chief Operating Officer

Position Responsibilities:

• Ensure that all product development activities are compliant with current regulatory and quality guidelines (FDA, GMP, ICH, USP, etc.).
• Manage and coordinate manufacturing and analytical activities with external vendors including identification and selection of vendors and technology transfers.
• Support the management of the Company’s quality system.
• Identify and track project goals, manage project budgets including updates and plans, and coordinate problem solving within the team.
• Provide written and oral communication of project status, goals and milestones to senior management.
• Maintain substantial knowledge of state-of-the-art principles and theories related to small molecule drug products and quality requirements and systems.
• Provide written technical content for research protocols and study reports.
• Participate in intellectual property evaluations and submission of patent applications.
• Participate in manuscript preparation and submission.
• Support written communications with government agencies, including NIH, DOD, and FDA.

Basic Qualifications:

• BS degree with 3-5 years of relevant CMC experience in the pharmaceutical industry.
• Ability to problem solve and demonstrated proficiency in written and verbal communication. 
• Ability to manage a wide range of project activities and a willingness to accept new responsibilities.
• Ability to work independently as well as in a team environment 
• Proficient in Microsoft Office applications. 
• Proactive approach and strong critical thinking skills

Desired/Preferred Qualifications:

• MS/PhD degree with 1-3 years of relevant CMC experience in the pharmaceutical industry.
• Experience in drug formulation development, including small molecule drug substances and drug products (e.g., nanosuspensions, oral formulations or sterile products).
• Experience with packaging, labeling and distribution of clinical and commercial drug products.
• Experience with critical review of analytical data and stability trends.
• Strong knowledge of FDA regulations governing drug approval and experience authoring or contributing to regulatory submissions.
• Experience working with or managing CDMOs or external partners

Salary/Benefits/Other:

• High visibility/high impact position.
• Salary commensurate with experience and expertise.
• Participation in annual bonus and restricted stock programs.
• 401(k) program.
• Health and dental insurance.
• Hybrid or remote work.
• Limited travel.