Director of Drug Substance Development
11 - 15 years experience •
Director of Drug Substance DevelopmentCan be located in; Lincolnshire, Illinois / Parsippany New Jersey / New Haven Connecticut.
Talent Orchard LLC is the retained recruiting partner for Melinta Therapeutics, we are managing the search for on behalf of Melinta for a, Director of Drug Substance Development. The role can be based in Lincolnshire, IL, Parsippany NJ, or New Haven CT. Expect around 25% travel including some international travel.
Melinta Therapeutics is the largest pure play antibiotics company in the US with a potential $1B in commercial and late stage development products, plus a robust early development pipeline. Our mission is to meet the continually evolving threat of bacterial infections by discovering, developing, and commercializing a continual stream of novel antibiotics.
Melinta is experiencing a rapid growth and transformation, in the past few months the firm has acquired significant new business via merger and acquisition, has become a publicly traded company and grown into a leader in its specialty. It is essential to the long-term success of the firm, that the drug substance supply chain for both current commercial products and for those in development is fully optimized. As a result Melinta has decided to hire a Director of Drug Substance Development to lead this critical initiative.
This Director of Drug Substance Development must possess the right blend of scientific knowledge combined with excellent people and project management skills. This role requires the ability necessary to both ?lead and do? while interacting effectively with all levels of the firm, vendors and external stakeholders. This is your opportunity to help build a highly effective drug development capability and positively impact the long-term financial stability of a firm poised to positively impact public health.
Ensuring drug substance supply and provision of associated data is a key underpinning of successful development, registration and supply to market of the company?s products. It is essential that individuals who lead and manage activities in this area possess deep experience, a high degree of technical competence, an ability to communicate accurately and positively (both in written documents and in verbal situations) and are prepared to act proactively and decisively in making progress towards company goals. The role requires an ability to address short to long term supply (and data acquisition) needs and setting of company strategy in respect of respect of drug substance needs over the life cycle of a program, from early development to commercial phases.
As the Director of Drug Substance Development you will;
- Design and implement manufacturing processes for drug substance together with control strategies to ensure robust outcomes (including critical parameter identification and analytical testing)
- Develop supply chain for drug substance supply for assigned program(s). This will encompass identification of development needs, establishment of suitable external partnerships (CROs/CMOs) and implementation of a supply strategy
- Manage and support production activities at external CMOs, including production planning, change management and GMP oversight. Lead troubleshooting and communication with internal and external team members
- Identify and introduce process improvements and cost of goods reductions. Oversee associated laboratory investigations and scale up/validation. Evaluate risks and financial impacts
- Lead technology transfer activities
- Collaborate with team members including Formulation Science, Quality Assurance, Regulatory Affairs and Supply Chain to achieve successful integration of drug substance activities with identified overall program requirements
- Ensure data requirements related to drug substances are satisfied, utilizing external resource as necessary (CROs)
- Identify and implement regulatory strategy for drug substances, in collaboration with respective development teams
- Establish project plan and budget that provide accurate timelines and costs associated with each drug substance. This may cover programs that are in development (pre-clinical and/or clinical) and at the post-approval/commercial stage
In order to successfully perform these duties you will likely have following education and skills;
- Good knowledge of overall requirements for drug development, with particular focus on drug substance aspect.
- Drug substance technical expertise (synthetic chemistry, scale up, analytical, engineering, awareness of formulation science).
- Knowledge of regulatory environment, specifically including requirements for drug substance sections of clinical and registration submissions.
- Understanding of philosophy and practice of cGMPs and rigorous approach to compliance.
- Good business sense leading to ability to develop advantageous but fair contractual agreements with external partners.
- Skillful management of external CROs/CMOs.
- High quality formal communication style (reports, presentations, etc).
- Ability to interact in an assertive and persuasive, but respectful and collaborative, manner with internal and external personnel at all levels, including within the direct reporting chain
- PhD in Organic Chemistry or Chemical Engineering preferred
- At least 10 years in chemical process development within a pharmaceutical environment, including management of external contractors.
- Experience of working in compliance with cGMPs. Exposure to process validation preferred
- Contributions to regulatory submissions.
- Preferably having gained exposure to factors impacting commercialization and supply management.