Associate Director/Sr. Manager, Vaccines & Biologicals

Society for Conservation Biology; Malvern (Chester County); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player seeks an Associate Director to lead CMC development for innovative therapies. This role involves overseeing critical processes from preclinical stages to commercial launch, ensuring smooth transitions and compliance with regulatory standards. You will manage a multidisciplinary team, develop project timelines, and implement best practices across the organization. If you have a strong background in biochemical engineering and a passion for advancing healthcare solutions, this opportunity could be your next career milestone.

Qualifications

• 5+ years in CMC with 2 years managing project teams.
• Expertise in upstream/downstream process development.

Responsibilities

• Coordinate CMC efforts from pre-IND to Phase III/Commercial programs.
• Collaborate with stakeholders to manage regulatory applications.

Skills

Project Management

Process Development

Regulatory Applications

Team Leadership

Conflict Resolution

Education

BS/MS/PhD in Chemical/Biochemical Engineering

Industry Experience in CMC

Job description

Job Title: Associate Director, CMC

Employer: Ocugen, Inc.

Location: Malvern, Pennsylvania, US

Salary: Competitive

Closing Date: May 10, 2025

Sector:

Consultancy/Private Sector

Field:

Conservation science

Discipline:

Biology

Job Level:

Senior level

Employment Type:

Full time

Job Purpose

The Associate Director, CMC will oversee phase-appropriate development of CMC work packages to ensure smooth progression of clinical and commercial assets, including Gene therapy, Vaccines, Biologics, and Cell Therapy Regenerative Medicine assets. The role focuses on process development, manufacturing strategies, Tech transfers, GMP manufacturing, Late-Stage development, and filing of INDs and BLAs. The candidate will lead a multidisciplinary team aligned with CMC objectives.

Duties and Responsibilities

1. Coordinate CMC efforts from pre-IND to Phase III/Commercial programs, assigning responsibilities to meet program timelines.
2. Collaborate with internal stakeholders and CDMOs to manage regulatory applications and build a CMC sub-team.
3. Use scientific and technical expertise to facilitate drug candidate progression into cGMP and CMC phases.
4. Develop program timelines and CMC processes for tech transfer and scale-up.
5. Conduct contingency planning, scenario analysis, and manage operational risks.
6. Report project status to teams and senior leadership.
7. Implement best practices across the CMC team and stakeholders.
8. Work with leaders to maintain team cohesion and effectiveness.
9. Prepare progress reports as needed.
10. Engage with CDMOs and identify potential partners for future projects.
11. Perform additional tasks and projects as assigned.

Qualifications

• BS/MS/PhD in Chemical/Biochemical Engineering or related biological sciences with at least 5 years of industry experience in CMC, including 2 years managing project teams.
• Expertise in upstream/downstream process development.
• Experience managing integrated project plans from preclinical to launch.
• Strong personal integrity, conflict resolution, and consensus-building skills.
• Ability to collaborate effectively across teams.

Working Conditions

• Primarily Monday - Friday office hours.
• Travel up to 30% may be required.

Ocugen is an equal opportunity employer. We base employment decisions on merit, qualifications, and conduct, without discrimination based on race, color, religion, sex, age, disability, or other protected characteristics.