Associate Director, Drug Product Development & Manufacturing

Jobgether; United States; A distancia; USD 175.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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.

Conocimientos

Leadership

Problem-solving

Collaboration

Analytical skills

Educación

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

Herramientas

DoE

JMP

Minitab

Descripción del empleo

We are currently looking for an Associate Director, Drug Product Development & Manufacturing in United States. This role offers the opportunity to lead drug product development and manufacturing operations for small molecule pharmaceutical programs in a fully remote and highly collaborative environment. You will oversee formulation development, process optimization, technology transfer, and clinical-to-commercial scale-up, ensuring readiness for both clinical trials and commercial launch. The position involves managing CDMOs, coordinating with cross-functional teams, and applying advanced analytical and statistical methods to drive robust, scalable processes. You will contribute to regulatory submissions, compliance activities, and quality management, while mitigating supply and manufacturing risks. This is a high-impact role where leadership, technical expertise, and strategic thinking combine to advance innovative therapies for patients. The role requires a hands‑on approach and strong collaboration across R&D, Quality, Regulatory, and Supply Chain functions.

Accountabilities

• Lead development of phase‑appropriate formulations and manufacturing processes for solid oral dosage forms.
• Oversee technology transfer from development to clinical and commercial manufacturing.
• Support process validation, process characterization, and lifecycle validation activities.
• Manage CDMOs, including selection, oversight, and performance management.
• Ensure uninterrupted supply of clinical trial materials and commercial launch readiness.
• Define product specifications, control strategies, and ensure process scalability and robustness.
• Apply Quality by Design (QbD), Design of Experiments (DoE), and statistical tools to optimize manufacturing processes.
• Coordinate with supply chain and manufacturing teams to support production planning and scheduling.
• Identify and mitigate risks related to supply and manufacturing.
• Author and review CMC sections for regulatory submissions and support inspections and audits.
• Ensure compliance with FDA, EMA, ICH, and cGMP requirements.

Requirements

• Advanced degree (PhD, MS, or BS) in Pharmaceutics, Chemistry, Chemical Engineering, or related field.
• 10+ years of experience in pharmaceutical drug product development, preferably supporting products from early development through commercialization.
• Strong expertise in solid oral dosage forms and pediatric formulations; understanding of analytical testing a plus.
• Hands‑on experience with DoE and statistical analysis tools (e.g., JMP, Minitab).
• Proven experience managing CDMOs and external partners.
• In‑depth knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Experience contributing to regulatory filings and supporting inspections.
• Demonstrated leadership, project management, and problem‑solving skills.
• Excellent communication and collaboration abilities in fast‑paced environments.
• Ability and willingness to travel up to 30%, including international travel.

Benefits

• Competitive salary range: $175,000–$190,000 USD.
• Standard benefits including medical, dental, vision, time off, and 401K.
• Participation in performance‑based incentive plans.
• Fully remote work with flexible arrangements.
• Opportunity to work on high‑impact pharmaceutical programs with cross‑functional teams.
• Exposure to regulatory submissions, clinical trials, and commercial‑scale manufacturing.
• Professional growth and development in a dynamic, innovative environment.