Director Formulation / Process Development
We seek candidates with the following qualifications:
Our client works through strategic partnerships with pharmaceutical companies, academic institution, research labs and contract service providers to advance a comprehensive portfolio of drugs to treat one of the world’s top killers. This not-for-profit organization acts as a virtual R&D unit and seeks a Director Formulation / Process Development to manage programs in the chemistry, manufacture, and control (CMC) area, and play a supporting role in advancing discovery and clinical programs.
- A Ph.D. in chemistry and pharmaceutical science or related disciplines from a well-respected academic institution.
- 5+ Years of working experience in a research and development capacity within a pharmaceutical/biotechnology company.
- E xperience in CMC with a thorough understanding of the requirements and processes needed to take a potential drug candidates from discovery into development and registration. An ideal candidate will be an expert in one specific area of CMC, such as process chemistry, manufacturing and formulation development, but have broad exposure in other aspects of CMC.
- A broad knowledge base in drug discovery, preclinical and clinical development and experience with both discovery and development programs.
- B road exposure to product development with an understanding of the complex interface between research and clinical development.
- Familiarity with regulatory guidelines governing the chemical, pharmacological, pharmacokinetic and toxicological aspects of a successful IND.
- An international network of contacts, recognition as a leader in the scientific community with a strong reputation in the life science arena.
- Ability to interact in a positive manner with governments, funding agencies and the highest level of research management in pharmaceutical/biotechnology companies.
- P roven management and leadership skills with the ability to work in a team-oriented environment.
- Ability to present well in an international setting and have the interest and ability to become an expert in the disease area.
- Strong communication, presentation and interpersonal skills with the ability to build effective working alliance.
- A sense of purpose and dedication to the mission of the organization and its not-for-profit focus.
Responsibilities will include:
Do you have the skills and experience we seek and want to apply and advance your skills among industry leaders committed to improving drug regimens against a major global disease? If so, please email your resume. Include your daytime contact information and we will contact you confidentially or reply to your email.
- Provide strategic leadership and manage CMC activities to support preclinical and clinical development programs.
- Support discovery programs by providing scientific and technical input and managing process development and preformulation studies.
- Be involved in the identification, evaluation and selection of potential portfolio projects
- Represent the alliance externally in scientific, business and regulatory meetings.
- Report progress to the R&D team, the management team and the Scientific Advisory Committee of the alliance.
- Stay current with scientific and technical advancements in drug development and ensure timely publication of research results