• Associate Project Manager (Pharma)

    Insight Global (East Greenbush, NY)


    Job Description

    A large pharmaceutical client is looking for an Associate Project Manager to join the team in Albany, NY. • Leading cross-functional teams and managing the planning and execution of deliverables for the assigned External Manufacturing projects related to the development strategy for molecule-specific programs (i.e.- Technical Transfers, Process Validation, new CMO selection, CapEx)

    • Acting as single point of contact for assigned project-related communications with external CMOs and internal REGN stakeholders (i.e. CMC Program Manager)

    • Leading projects and prioritizing using excellent organizational, communication and time management skills.

    • Ensuring teams and stakeholders are aligned on one single external manufacturing project plan.

    • Planning and tracking the project activities.

    • Facilitating regular project focused meetings with CMO and working teams (technical transfer, validation, new product launch, etc.).

    • Coordinating contingency and risk mitigation planning for projects.

    • Ensuring meeting minutes and weekly/monthly reports are completed and distributed accurately.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

    Skills and Requirements

    • Education: Bachelor’s degree in a relevant field (e.g., Engineering, Supply Chain, Life Sciences).

    • Experience:

    • Minimum 5 years of experience in serialization, packaging, and labeling within the pharmaceutical or biotechnology industry.

    • Proven track record of supporting investigations (validations, NOEs, EOEs, DNFs, CCs, CAPAs).

    • Experience working with external stakeholders, such as CMOs, 3PLs, and EMVOs.

    • Hands-on experience with track-and-trace systems, particularly Tracelink.

    • Strong understanding of regulatory guidance, including DSCSA, EU-FMD, and ROW.

    • Involvement in technical transfer projects is highly desirable.

    • Demonstrated experience in project management, including planning, coordination, and execution of sub-projects. • Familiarity with global serialization standards and emerging regulatory requirements.

    • Experience in managing serialization projects from initiation to implementation.

    • Certification in project management (e.g., PMP, MBA) or quality systems is a plus.