Why is remote work so nice? Let's try to see!
Apply
Executive Director, Biologics Drug Product
Posted 21 days agoViewed
💎 Seniority level: Executive, 15+ years
🔍 Industry: Biopharmaceutical
🏢 Company: Disc Medicine👥 51-100💰 $225,500,000 Post-IPO Equity 2 months agoPharmaceuticalBiotechnologyTherapeuticsMedicalHealth Care
🗣️ Languages: English
⏳ Experience: 15+ years
Requirements:
- B.S. degree is required. Advanced scientific degree Ph.D. in a related field is highly preferred.
- 15+ years of operations experience in the pharmaceutical/biopharmaceutical industry with a minimum of 12 years of leadership experience in leading antibody drug product development teams.
- Demonstrated broad knowledge in sterile drug product development, technology transfer, and manufacturing
- Prior experience in formulation development of antibody products through various stages of the product lifecycle, including first in human and commercial formulations
- Experience in IND and BLA filings is highly preferred
- Strong ability to communicate well with cross-functional groups, including Drug Substance, Analytical Development, Quality, Regulatory, and Program Management
- Demonstrated ability in managing a department and associated budget
- Substantial experience working in CMC teams – with CMC leaders and related team leaders. Preferred to have experience as a CMC leader
- Strong network and prior experience with antibody drug product CDMOs
- Ability to provide excellent leadership to develop high-performing teams, including exceptional communication and one-team spirit
- Excellent collaboration and interpersonal skills; Ability to convey complex ideas succinctly
- 20-30% travel required
Responsibilities:
- Lead the drug product function for biologics programs at Disc Medicine
- Oversee drug product manufacturing at contract development and manufacturing organizations (CDMO)s
- Lead commercial formulation development for antibodies
- Engage in selecting appropriate external providers, including formulation and fill/finish process development.
- Provide expertise in various areas of biologics drug product, such as in-use compatibility studies.
- As appropriate, engage in drug product transfer from one site to another
- Provide leadership in performing successful drug product process performance qualifications
- Manage a team of individuals and build the function that is poised for growth along with the rest of the company
- Form effective relationships and collaborate well with the CMC leader and CMC functions, including drug substance, analytical development, quality control, supply chain, and quality and regulatory organizations.
- Responsible for budget management
- Engage with Executive Leadership as appropriate to proactively identify technical risks and provide scientific recommendations for mitigation
- Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.
Related Articles
Posted 7 months ago
Insights into the evolving landscape of remote work in 2024 reveal the importance of certifications and continuous learning. This article breaks down emerging trends, sought-after certifications, and provides practical solutions for enhancing your employability and expertise. What skills will be essential for remote job seekers, and how can you navigate this dynamic market to secure your dream role?
Posted 8 months ago
Explore the challenges and strategies of maintaining work-life balance while working remotely. Learn about unique aspects of remote work, associated challenges, historical context, and effective strategies to separate work and personal life.
Posted 8 months ago
Google is gearing up to expand its remote job listings, promising more opportunities across various departments and regions. Find out how this move can benefit job seekers and impact the market.
Posted 8 months ago
Learn about the importance of pre-onboarding preparation for remote employees, including checklist creation, documentation, tools and equipment setup, communication plans, and feedback strategies. Discover how proactive pre-onboarding can enhance job performance, increase retention rates, and foster a sense of belonging from day one.