Senior Director, CGT CMC and Analytics

3 weeks ago

Exton, United States Pharmaron Full time
Job DescriptionJob Description


Pharmaron is a full-service contract research organization (CRO) developing innovative services and solutions for the pharmaceutical, biotech, medical device, and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device, and cell and gene therapy products. The company's US Lab Services and CGT facilities are strategically located in Philadelphia, San Diego, Germantown, and Boston, servicing hundreds of customers throughout the world. Our facilities are USDA registered, NIH assured, AAALAC accredited, GLP & cGMP compliant, ISO certified, DEA licensed, OLAW assured, and FDA inspected. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company's comprehensive contract services and applied research programs, please visit www.pharmaron.com


Job Summary:
The Senior Director, CGT CMC and Analytics will be responsible for the overall scientific
management of the CGT CMC and Analytics division for Pharmaron US Lab Services sites. This includes oversight of all activities (R&D, GXP), including project and timeline management, budget, personnel, P&L, and quality control across the two east coast sites of Philadelphia (Exton) and Boston (Woburn). This position has the responsibility for a staff of 20+.


Principal Duties and Responsibilities

  • To drive business growth by providing existing and potential new clients with scientific
    confidence and ensuring successful project execution through effective team leadership, project management, and compliance with quality standards.
    ● Directs the day-to-day activities of the Cell and Gene Therapy CMC and Analytics group. This includes streamlining and supporting the conduct of cell-based potency assays for GT and CT products, building analytical release assays to expand capabilities, and guiding initiatives (e.g., POC assay development) to facilitate lead selection and improved connectivity with upstream offerings.
    ● Leads with the 'end in mind', tying together R&D to GXP operations resulting in a
    successful outcome for the client.
    ● Manages a diverse team of 20+ scientists and project managers in Philadelphia and Boston
    ● Responsible for the sound project and financial management of the group, including
    preparation of and adherence to budgets and standards for cost measurement. Directs
    project management and technical execution teams to remain within approved budgets and timelines.
    ● Leverages a strong business acumen to partner with the business development and
    operations team ensuring successful client outcomes.
    ● Manages and drives all delivery functions in collaboration with project management to
    optimize efficiency.
    ● Provides sponsors and collaborators with high-quality and timely production status reports.
    ● Establishes strong relationships with internal and external key stakeholders to ensure the timely and successful completion of all projects.
    ● Develops a framework of follow-up services to retain current clients.
    ● Builds scientific collateral to showcase capabilities and provide confidence to the clients.
    ● Sets the strategic path and drives the continued growth of the Cell and Gene Therapy CMC and Analytics group.
    ● Positions Pharmaron US Lab Services as an industry leader in the Cell and Gene Therapy space through active participation in trade organizations and regulatory bodies.
    ● Participates in efforts to create an End-to-End service line for CGT at Pharmaron.

Knowledge, Skills, and Abilities Required

  • Advanced degree in biological sciences.
    ● A seasoned professional with extensive scientific, project delivery, and people
    management experience.
    ● Experience in cell and gene therapy is a must. Demonstrated and recognized expertise in Virology, Biology, Analytical Development, and Bioprocessing (Upstream and Downstream).
    ● Broad and deep understanding of technology needs and direction in Viral Vectors, Gene Therapy, and Gene-modified Cell Therapy.
    ● Knowledge of GMP and GLP regulations
    ● Experience in GMP operations with knowledge in the tech-transfer/scale-up/analytical
    testing of bio-therapeutics.
    ● Proven ability in analytical development and to improve and refine analytical testing for testing in a GMP environment.
    ● Knowledge of regulations governing the analytical testing of biopharmaceuticals as
    mandated by governing bodies.
    ● Strong business acumen
    ● Strong analytical and problem-solving skills
    ● Experience in budget management and business development.
    ● Ability to make timely decisions.
    ● Ability to communicate clearly and efficiently (written & verbal)
    ● Willingness to take ownership and execute multiple projects.
    ● Excellent interpersonal skills with ability to communicate and work with all levels of the organization and influence in a matrixed environment.

Additional Position Requirements

  • On-site position: The position requires constant interactions with team members and
    being available to multi-site team members based on their needs.
    ● Travel will be required across the sites that support the Service Line and for Business
    Development purposes.

Benefits:

Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

  • Medical, Dental & Vision Insurance Plan with Employer Contribution
  • Health Reimbursement Account Funded by Employer
  • Healthcare & Dependent Care Flexible Spending Accounts
  • Employee Life and AD&D Insurance 100% Employer Paid
  • Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
  • Short and Long Term Disability 100% Employer Paid
  • 401k with Employer Match
  • Employee Assistance Program

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.

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