Job Description
Our pharmaceuticals client with a reputation for excellence is developing therapeutics that address unmet medical needs in women’s health. Their current pipeline leverages the 505(b)(2) regulatory pathway with new formulations of existing pharmaceuticals. The Company has a successful history in developing pharmaceutical products, including a progesterone gel which is commercially available in the United States and over 90 countries around the world. Their three development products are for the treatment of overactive bladder in women, another for the relief of menopausal symptoms and finally a product for the prevention of preterm birth in women with a short cervical length at mid-pregnancy.
The role holder will develop, maintain and manage the formulation & manufacturing aspects of a product development portfolio to support the company’s strategic growth. They will be part of a successful team responsible for the generation of intellectual property, proof of concepts, development, optimisation and manufacture of Women’s Health products for timely delivery to clinic and ultimately commercial regulatory approvals.
A proven track record in developing and manufacturing a range of different products and technologies across various stages of the drug product development process, from pre-clinical feasibility to late stage clinical trials and regulatory fillings is essential. In addition, knowledge of the requirements of drug device combinations and the provision of documentation to support the filing of regulatory submissions for review and approval by regulatory authorities in the EU & US is required.
In addition, the ability and willingness to coach and mentor a formulation & manufacturing technical team to develop their scientific and quality understanding in the field of product development and characterisation is essential. The candidate will provide leadership and strategy for product development programs, and have an appreciation of API development and manufacture, analytical testing, medical device development and characterization requirements to accelerate delivery of successful combination product designs.
