Senior Director, Commercial Manufacturing, Science and Technology

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Director, Commercial Manufacturing, Science and Technology in the United States.

This is a high-impact leadership opportunity for an experienced pharmaceutical manufacturing expert to drive commercial manufacturing strategy and technical operations for late-stage and commercial small molecule drug products. In this role, you will oversee complex manufacturing activities across global CDMO partners while ensuring operational excellence, regulatory compliance, and product quality. You will lead technology transfers, process validation initiatives, and lifecycle management activities that support successful commercialization and continuous improvement efforts. The position offers extensive cross-functional collaboration with teams across CMC, Quality, Supply Chain, and Regulatory Affairs in a fast-paced and innovation-focused environment. Ideal for a strategic and technically driven leader, this role combines scientific expertise, operational leadership, and external partnership management to support the delivery of critical therapies to patients with unmet medical needs. This remote position also offers the opportunity to contribute to cutting-edge advancements within the biotechnology and pharmaceutical industry.

Accountabilities:

• Lead commercial drug product manufacturing and CMC lifecycle activities for late-stage and commercial small molecule programs.
  • Oversee relationships and technical operations with Contract Development and Manufacturing Organizations (CDMOs), ensuring delivery of high-quality products on time and within budget.
  • Serve as the primary technical expert and key point of contact for manufacturing partners and cross-functional internal stakeholders.
  • Drive successful technology transfers and scale-up activities for commercial manufacturing environments.
  • Provide leadership and oversight for process validation, process monitoring, product risk management, and lifecycle optimization initiatives.
  • Analyze manufacturing processes, identify improvement opportunities, and implement innovative solutions to improve efficiency, product quality, and cost-effectiveness.
  • Troubleshoot and resolve complex manufacturing and technical challenges across production and development activities.
  • Ensure compliance with cGMP standards, regulatory requirements, and global quality expectations throughout manufacturing operations.
  • Support regulatory submissions by authoring and reviewing CMC sections for IND, IMPD, NDA, and related filings.
  • Establish and monitor key performance indicators (KPIs) to evaluate manufacturing performance and operational effectiveness.
  • Lead cross-functional collaboration across Quality, Regulatory, Supply Chain, and Technical Operations teams to meet program goals and timelines.
  • Mentor and guide team members while fostering a culture of innovation, accountability, and continuous improvement.

Requirements:

    - PhD, Master’s degree, or Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
    - Extensive pharmaceutical or biotechnology industry experience within CMC and cGMP-regulated environments.
    - Strong leadership experience managing CDMOs and overseeing commercial manufacturing operations for late-stage and commercial assets.
    - Deep expertise in small molecule drug product development and manufacturing, particularly solid oral dosage forms.
    - Hands-on knowledge of manufacturing processes such as blending, granulation, tablet compression, film coating, and advanced drug delivery technologies.
    - Proven experience leading technology transfers, process validation, scale-up activities, and commercial manufacturing initiatives.
    - Strong understanding of global regulatory requirements and guidelines including FDA, EMA, ICH, and cGMP standards.
    - Experience preparing and reviewing CMC regulatory documentation and supporting global regulatory submissions.
    - Excellent analytical, problem-solving, and technical troubleshooting capabilities in complex manufacturing environments.
    - Strong communication and presentation skills with the ability to engage effectively with executive leadership, vendors, regulators, and cross-functional teams.
    - Demonstrated ability to lead matrixed teams, influence stakeholders, and drive operational and strategic initiatives.
    - Proficiency with scientific and business software applications and familiarity with safe laboratory and manufacturing practices.
    - Ability to travel up to 30% as needed to support manufacturing operations and external partnerships.
    - Industry experience in outsourcing, vendor selection, and commercial manufacturing strategy is highly preferred.

Benefits:

        - Competitive salary range with performance-based bonus opportunities.
        - Ongoing stock awards and long-term incentive programs.
        - Fully remote work flexibility within the United States.
        - 100% employer-covered medical, dental, and vision insurance premiums for employees and eligible family members.
        - Financial support toward in-network healthcare deductibles.
        - 401(k) retirement plan with company match and immediate vesting.
        - Generous paid time off and company-supported work-life balance initiatives.
        - Fully paid parental leave and family medical leave programs.
        - Company-paid short-term disability coverage.
        - Tuition reimbursement and continuous learning opportunities.
        - Wellness programs and inclusive family-forming support benefits.
        - Collaborative and innovation-driven work environment with opportunities for professional growth and leadership development.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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