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- Director, Pharmaceutical Development
Location: East Coast
Main Functions:
Provide oversight management of and technical leadership for new product technology group.
Responsibilities include developing new product ideas and strategies, technology
assessment of
pharmaceutical products and drug delivery technologies, and oversight of analytical
chemistry,
product formulation, and clinical studies. Assists with regulatory affairs, quality
assurance and
outsourcing activities.
Specific Responsibilities:
1. Ensure adequate technical staff to meet corporate objectives.
2. Manage and prioritize development projects.
3. Support Pharma staff in evaluating new product opportunities.
4. Part of team to develop and market new pharmaceutical products.
5. Assists in developing regulatory strategies for existing and new products.
Education:
Ph.D., Pharm D. or equivalent in pharmacy, pharmacology, pharmaceutics or
related field.
Experience:
10 or more years with increasing responsibilities in various aspects of pharmaceutical
development. Should have strong leadership skills and should have had both science and
research management responsibilities. Candidate should have a demonstrated experience with
drug delivery systems to include FDA approvals. Experience with sterile
products would be preferred.
Specific Skills:
Knowledge and experience in the drug development process as well as the regulatory
requirements to meet NDA/ANDA guidelines. Vision to conceptualize new
product opportunities within a small company environment. A working knowledge of cGMP
guidelines is essential. Experience in outsourcing science and technology is important.
Desirable Skills:
Experience with US and non-US regulatory audits and agencies. A working knowledge of
project management and information technology concepts. Ability to
communicate clearly and succinctly both orally and in writing.
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To express your interest in this
position,
visit our Applicants page
to fill out the short registration form
or
E-mail Harlan Staffing Consultants. |