Remote Associate Director: Drug Product Dev & Manufacturing

Jobgether; United States; Teletrabalho; USD 175 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary range: $175,000–$190,000 USD

Standard benefits including medical, dental, vision, and time off

Participation in performance-based incentive plans

Fully remote work with flexible arrangements

Resumo da oferta

A leading pharmaceutical company is seeking an Associate Director for Drug Product Development & Manufacturing, a fully remote role. You will oversee formulation development, manage CDMOs, and ensure compliance with regulatory standards. The ideal candidate has over 10 years of experience in drug product development and strong project management skills. This position offers a competitive salary, standard benefits, and the opportunity to work on impactful pharmaceutical programs with cross-functional teams.

Qualificações

• Advanced degree in a relevant field is required.
• 10+ years of experience in pharmaceutical drug product development.
• Strong expertise in solid oral dosage forms and pediatric formulations.
• Hands-on experience with DoE and statistical analysis tools.
• Proven experience managing CDMOs and external partners.
• Knowledge of cGMP, FDA, EMA, and ICH guidelines.

Responsabilidades

• Lead development of phase-appropriate formulations for solid oral dosage forms.
• Oversee technology transfer from development to clinical and commercial manufacturing.
• Manage CDMOs, including selection and performance management.
• Define product specifications and ensure process scalability.
• Author and review CMC sections for regulatory submissions.

Conhecimentos

Leadership

Problem-solving

Collaboration

Analytical skills

Formação académica

PhD, MS, or BS in Pharmaceutics, Chemistry, or related field

Ferramentas

DoE

JMP

Minitab

Descrição da oferta de emprego

A leading pharmaceutical company is seeking an Associate Director for Drug Product Development & Manufacturing, a fully remote role. You will oversee formulation development, manage CDMOs, and ensure compliance with regulatory standards. The ideal candidate has over 10 years of experience in drug product development and strong project management skills. This position offers a competitive salary, standard benefits, and the opportunity to work on impactful pharmaceutical programs with cross-functional teams.