Global Life Science Hub is partnered with a niche, specialist biopharmaceutical company offering next-generation drug delivery technologies and an advanced pipeline of oral and biosimilar drugs. They aim to improve patient outcomes through innovative drug delivery technologies and therapeutic solutions.
Following a recent FDA approval, they seek an experienced and visionary Senior Director/Vice President of Manufacturing to oversee their biologics manufacturing operations and drive their supply chain strategies.
The ideal candidate will have a strong background in biologics manufacturing and a proven track record of successfully managing complex manufacturing processes while ensuring quality and regulatory standards adherence. This role requires a strategic thinker who can effectively optimize manufacturing operations, foster innovation, and lead cross-functional teams to deliver high-quality products on time and within budget.
Responsibilities:
- Develop and execute the overall manufacturing strategy in alignment with the company's goals and objectives, with a particular focus on biologics production and supply chain management.
- Provide strong leadership and guidance to the manufacturing team, fostering a culture of continuous improvement, collaboration, and accountability.
- Oversee all aspects of biologics manufacturing operations, including process development, technology transfer, scale-up, and commercial production, while ensuring compliance with cGMP regulations and industry standards.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to ensure seamless integration of manufacturing activities across the organization.
- Lead efforts to optimize manufacturing processes, improve efficiencies, and reduce costs while maintaining high-quality standards and meeting production targets.
- Drive the implementation and adoption of advanced manufacturing technologies and automation systems to enhance productivity, reduce cycle times, and increase manufacturing capacity.
- Establish and maintain effective relationships with key suppliers and contract manufacturing organizations (CMOs) to ensure reliable and cost-effective supply of raw materials, intermediates, and finished products.
- Collaborate with the Quality Assurance team to establish and maintain a robust quality management system, ensuring compliance with applicable regulations and industry best practices.
- Develop and monitor key performance indicators (KPIs) to track manufacturing performance, identify areas for improvement, and drive operational excellence initiatives.
- Stay abreast of industry trends, technological advancements, and regulatory changes related to biologics manufacturing and supply chain management, and proactively recommend strategies to maintain a competitive edge.
Experience/Qualifications:
- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
- Minimum of 10 years of progressive leadership experience in biologics manufacturing, with a strong focus on biopharmaceuticals.
- Extensive knowledge of cGMP regulations and quality systems applicable to biologics manufacturing.
- Proven track record of successfully managing and optimizing biologics manufacturing processes, including process development, scale-up, and commercial production.
- Demonstrated experience in implementing advanced manufacturing technologies and automation systems in a biologics manufacturing environment.
- Strong leadership and team-building skills, with the ability to effectively motivate and develop high-performing teams.
- Excellent problem-solving and decision-making abilities, with a strategic mindset and the ability to think critically in complex situations.
- Outstanding communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, senior management, and external partners.
- Demonstrated ability to manage multiple priorities and projects simultaneously, while ensuring timely completion and adherence to budgetary constraints.
- Knowledge of biologics supply chain management and experience in establishing and maintaining relationships with suppliers and contract manufacturing organizations (CMOs) is highly desirable.
Apply:
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com
United States
