Blue Signal Search
Our client is an innovative, international leader in the biotech industry. They are manufacturing medications and medical processes that will revolutionize the healthcare industry as a whole and change the way we treat illness. They are hiring a Director of CMC to lead the overall planning, oversight, and execution of chemistry, manufacturing, and controls operations throughout all phases of development.
The Director of CMC is responsible for the strategic planning of the CMC program alongside colleagues, academic collaborators, consultants, investors, and other strategic partners. This person will play a large role in the success of this organization in their beginning growth stage, while shaping manufacturing processes and programs as they see fit.
This Role Offers:
• Competitive base salary and comprehensive benefits plan, including medical/dental/vision, 401K match, generous vacation time, and more.
• Opportunity to develop niche skills in the highly competitive, newly developed, and technologically advanced biotechnology space.
• Company at the beginning stages of an incredible growth phase offering extensive career advancement paths.
• Highly experienced leadership with deep market expertise and product marketing experience.
• High degree of autonomy to bring fresh perspective to the business development team and restructure processes and relationships.
• Ability to help the company tap into a global marketplace and be a part of the key support system that leads to the next big breakthrough in biomed.
• Develop and implement a strategy for optimizing and controlling quality of bulk API and DP using CROs and CMOs.
• Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization in support of ongoing biotech programs.
• Direct program improvements by reviewing development strategy, program timeline, program budget, resources, and overall risk.
• Support the maintenance of integrated control strategies throughout a program’s life cycle.
• Establish relationship and maintain contact with key stakeholders including, quality assurance, regulatory affairs, research, legal, finance, and program management.
• Prepare, review, or edit GMP manufacturing records, CMC, and quality documents.
• Support the development of product control strategy, including risk assessments, and process characterization strategies.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.
• Ph.D. in related field such as Chemistry or Biology, required.
• 7+ years of experience in biotechnology and/or pharmaceuticals manufacturing and operations.
• In-depth knowledge of biologics manufacturing through all phases of development with a background in protein biochemistry or strong background in small molecules plus DP and API development a must.
• Proven success onboarding and managing CROs and working with cross-functioning teams.
• Highly skilled in managing process improvement, operational efficiency, and strategic planning.
• Knowledge of major industry players and clients, market trends, emerging and disruptive biotechnologies, and methodologies.
• Expert level ability in handling multiple priorities and projects at once while meeting deadlines.
• Excellent written and verbal communication; comfortable delivering presentations to C-level executives and high-profile stakeholders.
To apply for this job please visit www.bluesignal.com.