A top pharmaceutical company is currently seeking a Director to join their Drug Product Development team local to the greater Philly region. They have an extensive traditional biologic pipeline ranging from early to late stages of development. The ideal individual will have a strong background in a variety of modalities such as mAbs, ADCs, and proteins with prior experience leading and managing an internal team/ external vendors such as CDMOs or CROs. This opportunity will allow for an individual to gain long term growth in their career development.
Responsibilities:
oversee the entire lifecycle of biologic product development, from early-stage research through clinical trials and commercialization, ensuring projects are completed on time and within budget.
Collaborate with cross-functional teams, including regulatory affairs, quality assurance, manufacturing, and marketing, to ensure successful product development and launch.
Ensure all activities comply with relevant regulatory guidelines and standards (e.g., FDA, EMA, ICH), and prepare necessary documentation for regulatory submissions.
Conduct market assessments to identify opportunities for new biologic product development and enhancements to existing products, guiding strategic decision-making.
Communicate project status, risks, and opportunities to senior management and stakeholders, ensuring transparency and informed decision-making.
Mentor and develop team members, promoting professional growth, skill enhancement, and a high-performance culture.
Qualifications
Advanced degree (Ph.D. or equivalent) in a relevant scientific discipline (e.g., biology, biochemistry, pharmaceutical sciences)
10+ years of experience in drug product development, with a focus on biologics, including leadership roles.
In-depth understanding of regulatory requirements and processes for biologics development.
Strong background in formulation science, process development, and analytical techniques specific to biologics.
Proven ability to lead cross-functional teams and manage complex projects in a fast-paced environment.
Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse audiences.