| Job Description | Head of Drug Formulations
Dart NeuroScience LLC (DNS) is a privately held Delaware Limited Liability Company with offices in San Diego, CA. DNS will discover new technologies and develop new therapies to help maintain cognitive vitality throughout life.
Dart NeuroScience, LLC is looking for a group leader of a new formulations group within the CMC Department. This position will manage all in-house activities related to pre-formulation, analytical method generation and early clinical formulation development for DNS’s drug discovery and development programs. The successful candidate will be actively involved in transferring these analytical methods and processes to cGMP drug product manufacturers and will work closely with the selected CMOs to manufacture the formulations throughout clinical trials. Additionally, the successful candidate will build a staff of highly qualified scientists and associate scientists and will be responsible for their mentorship and career development. As this group represents a new function within DNS, it will be required that the scientist in this role build the necessary infrastructure of the pharmaceutical sciences lab, including purchase and set up of all required equipment and to oversee the activities of a highly talented product development staff. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role with the expectation that this scientist will interact with all disciplines in the drug development pipeline, including discovery, CMC, pre-clinical, clinical and regulatory. A thorough understanding of what is required to advance an NCE from discovery to a commercializable drug product is essential.
Duties and Responsibilities
Provide strategic direction and guidance to all discovery and development programs in the DNS pipeline
Provide innovative solutions to challenging CNS drug formulations
Build and manage budgets and timelines that are commensurate with DNS achieving milestones in its drug development projects
Evaluate, select and manage appropriate CMOs that will do additional development, if required, and cGMP manufacture of drug product for clinical studies
Ensure that clinical supplies are available on time for all clinical studies in U.S. and abroad
Integrate into drug discovery teams to advise and inform on what compounds are most appropriate to move into development status from a formulations perspective
Participate in clinical development project team to inform and update the team on the status of all active projects
Write and review CMC reports and documentation for regulatory filings
Build the formulation development infrastructure
Recruit, manage and provide growth opportunities for highly qualified scientists and associate scientists
Requirements
A Ph.D. in pharmaceutical sciences or chemical engineering with at minimum of 10 years of relevant experience in a pharmaceutical/biotechnology company
In-depth understanding of pharmaceutical formulation principles and operations
Demonstrated experience with successfully developing formulations for small molecule, oral dosage drugs in both early and later stage development programs; participation in programs that went to NDA is not required, but would be helpful
Successful development of challenging formulations to improve bioavailability is a must
Innovative approaches to solving formulations challenges that may enable patent life extension of development candidates
CNS drug development experience preferred, but not required
Experience in managing scientific personnel
Experience in managing multiple projects, both in-house and with external CMOs
Strong knowledge of cGMP requirements
Ability to work with the wide range of disciplines required to get a drug from discovery through clinical development
Excellent verbal, written and interpersonal skills required
Ability to work in a fast-paced organization with diverse project teams and personnel
Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents
Commitment to excellence
DNS offers competitive salaries and a great benefits package including incentive bonuses, healthcare, vision, dental, long-term disability, life insurance and a 401(k) retirement savings plan. |
| | Company | | Dart NeuroScience LLC | Job Code | | State or Province | | California | | |
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