Associate Director/Sr. Manager, Vaccines & Biologicals

Initial Therapeutics, Inc.; Malvern (Chester County); On-site; USD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking an Associate Director for CMC to lead the development of clinical and commercial assets in gene therapy, vaccines, and biologics. This pivotal role involves overseeing cross-functional teams, managing regulatory applications, and ensuring effective communication with stakeholders. The ideal candidate will have a strong background in chemical engineering and CMC processes, along with proven project management skills. Join a dynamic environment where your expertise will drive innovation and contribute to the advancement of life-changing therapies. If you are ready to take on a leadership role in a collaborative setting, this opportunity is for you.

Qualifications

• 5+ years in CMC pharmaceutical industry with 2+ years in project management.
• Expertise in upstream/downstream process development and regulatory applications.

Responsibilities

• Coordinate CMC efforts from pre-IND to Phase III/commercial programs.
• Manage regulatory applications and build out a CMC sub-team.

Skills

Project Management

CMC Expertise

Conflict Resolution

Cross-Functional Team Leadership

Education

BS in Chemical/Biochemical Engineering

MS in Biological Science

PhD in Biological Science

Job description

Job Purpose

The Associate Director, CMC will be responsible for overseeing phase-appropriate development of CMC work packages to ensure streamlined progression of clinical and commercial assets which include Gene therapy, Vaccine, Biologics and Cell Therapy Regenerative medicine assets. The role will focus on internal/external process development with novel platforms, developing robust manufacturing strategies, Tech transfers, point-of-contact for GMP manufacturing, Late-Stage development, Filing of INDs and BLAs. This team member will build, coordinate, and guide a multi-functional team with varying incentives and priorities related to the CMC function.

Duties and Responsibilities:

• Coordinate CMC related efforts from pre-IND to Phase III/commercial programs, leveraging cross functional team members assigning responsibilities to ensure program timelines are achieved.
• Work with internal stakeholders and CDMO to manage regulatory applications, build out a CMC sub-team leveraging internal team members across the organization.
• Utilize scientific and technical expertise to streamline drug candidate movement into cGMP and CMC phases.
• Participate in development of program timelines and CMC process for tech transfer and scale up.
• Conduct contingency planning, perform scenario analysis, identify and manage operational risks and issues.
• Ensure project communication and report project status to project team and Senior Leadership.
• Recommend and implement best practices across CMC team and program stakeholders.
• Work with functional leaders to ensure positive team spirit and high functioning team.
• Prepare monthly progress reports and ad hoc reports as required.
• Interface as needed with CDMO, identify potential CDMOs for future projects.
• Additional tasks and projects as requested.

Qualifications:

• BS/MS/PhD in a Chemical/Biochemical Engineering or any related biological science discipline with a minimum of 5 years of CMC pharmaceutical industry experience, with at least 2 years managing multi-functional project teams.
• Demonstrated expertise in either upstream and downstream aspects of the process development.
• CMC/Manufacturing/clinical expertise and managing integrated project plans from preclinical to launch.
• High level of personal integrity and strong conflict resolution and consensus building skills.
• Ability to work effectively with cross-functional teams.

Working Conditions:

• Incumbent will primarily work Monday – Friday during normal business hours in an office environment.
• Travel up to 30% may be required.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.