Job Description

Do you thrive in a fast-paced environment and have a passion for developing cutting-edge therapies?

We're a biopharmaceutical company dedicated to developing life-saving treatments for neglected and tropical diseases. We're seeking a highly experienced and motivated Director, Drug Product Manufacturing SME to join our team. This is a fully remote position, offering flexibility and the opportunity to make a significant impact on global health.

What You'll Do:

Lead the planning and execution of drug product manufacturing strategies for all stages of development.
Serve as a technical expert in all aspects of large molecule drug product manufacturing, including formulation, filling, and lyophilization.
Collaborate closely with cross-functional teams, including research, development, quality, and regulatory affairs.
Oversee technology transfer activities and ensure successful manufacturing at contract manufacturing organizations (CMOs).
Lead process validation activities and ensure compliance with regulatory requirements.
Investigate and resolve manufacturing issues, ensuring timely and effective resolution.
Contribute to the development and submission of regulatory filings.
Stay abreast of the latest advancements in drug product manufacturing technologies.
What You'll Bring:

PhD or equivalent with 10+ years of experience in biologics process development.
Deep expertise in large molecule drug product manufacturing, including a strong understanding of regulatory requirements.
Proven experience in managing complex projects and leading cross-functional teams.
Experience with regulatory submissions (IND to BLA) for protein therapeutics.
Excellent communication, interpersonal, and leadership skills.
Strong analytical and problem-solving skills.
A passion for developing life-saving therapies and improving global health.
Why Join Us?

Make a real impact: Contribute to the development of life-saving treatments for neglected diseases.
Work with cutting-edge technologies: Be at the forefront of innovation in the biopharmaceutical industry.
Enjoy a rewarding career: Benefit from competitive compensation, comprehensive benefits, and opportunities for professional growth.
Work remotely: Enjoy the flexibility and convenience of working from home.
Join a mission-driven company: Contribute to a company dedicated to improving global health.
Employment Type: Full-Time
Salary: $ 130,000.00 Per Year

Job Tags

Contract work, Work from home,

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