Technical Development Lead - The Steely Group

As the Technical Development Lead you will lead the drug product team in partnering with the R&D team for development of drug product and drug product manufacturing process, as well as partnering with the internal and external GMP manufacturing teams to support the supply of GMP product for clinical studies. You will participate in the cross-functional planning and execution of pipeline programs, ensuring alignment with key company objectives and regulatory compliance. You will manage and oversee the drug product lifecycle, from early-stage development through clinical phase III, managing cross-functional teams and optimizing resources to drive successful outcomes. This is a senior leadership role that requires a proactive and collaborative individual who can navigate complex projects in a fast-paced biotech environment. The level of this position will be based on the final candidate’s qualifications.

Responsibilities:

• Strategic Leadership and Direction:
  • Oversee the end-to-end development of injectable drug products from concept to commercialization.
  • Set strategic goals, priorities, and timelines for the drug product development team.
  • Collaborate with cross-functional teams, including R&D, regulatory, manufacturing, and quality assurance, to ensure alignment on product goals.
• Project Management:
  • Lead multiple development projects, ensuring that milestones and deadlines are met.
  • Allocate resources efficiently across projects, balancing team workloads and ensuring high-quality output.
  • Monitor project progress and adjust strategies as needed to address challenges or delays.
• Technical Oversight:
  • Provide guidance on formulation development, process design, and scale-up activities.
  • Ensure that product development follows industry best practices and complies with Good Manufacturing Practices (GMP).
  • Review and approve technical documents, including protocols, reports, and specifications.
• Regulatory Compliance:
  • Ensure that all products are developed in compliance with relevant regulatory requirements (FDA, EMA, etc.).
  • Support the preparation and review of regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDA).
  • Maintain an understanding of current regulatory trends and implement necessary adjustments in product development processes.
  • Innovation and Continuous Improvement:
  • Drive innovation in injectable drug formulations, delivery systems, and manufacturing processes.
  • Promote continuous improvement initiatives within the team to optimize development timelines and product quality.
• Team Leadership and Development:
  • Lead, mentor, and manage a team of engineers, providing guidance, technical support, and career development opportunities.
  • Foster a collaborative and high-performance culture within the team.
  • Conduct performance reviews, set individual and team objectives, and create development plans for staff.
• Stakeholder Communication:
  • Serve as the primary point of contact for internal and external stakeholders related to drug product development projects.
  • Communicate project status, challenges, and opportunities to senior leadership.
  • Build relationships with external partners, including contract manufacturers and research organizations.
• Budget and Resource Management:
  • Develop and manage the department's budget, including resource allocation for personnel, equipment, and external services.
  • Track spending to ensure alignment with financial goals and project needs.
• Risk Management:
  • Identify potential risks in product development, including technical, regulatory, and operational risks.
  • Develop risk mitigation strategies and contingency plans to address challenges in development.
• Cross-Functional Collaboration:
  • Collaborate with quality control, manufacturing, and supply chain teams to ensure smooth tech transfer and scale-up of products.
  • Work closely with marketing and commercial teams to align development efforts with market needs and customer requirements.
• This role combines technical expertise, strategic leadership, and team management skills, ensuring the successful development and launch of injectable drug products.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Business Administration, or a related field (Master’s or Ph.D. preferred).
• Minimum of 10 years of experience in biotech or pharmaceutical program management, with an emphasis on Clinical stage II and III. Minimum of 3 years’ experience in a team leadership role.
• Proven track record of successfully managing complex biotech programs, from early development through Clinical Phase III.
• Deep understanding of regulatory requirements and novel drug development processes in the biotech space.
• Exceptional leadership and communication skills with experience leading cross-functional teams.
• Ability to work in a fast-paced, dynamic environment with a focus on delivering results.