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    Manager - Product Manager - England, United Kingdom - The RFT Group

    The RFT Group
    The RFT Group England, United Kingdom

    1 week ago

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    Description
    Drug Product Senior Manager / Manager

    The main task of the Manager, Drug Product, is to lead projects from the technical feasibility evaluation through commercial registration of the company drug product portfolio.

    The preferred candidate will have experience of drug product formulation for inhaled products in combination with drug product development as well as strong vendor management.

    This role can be remote within in Europe, the UK or the US.

    Develop and execute the strategy for development and clinical study production of company drug products in alignment with company goals and clinical plans.

    Oversee all CMC-DP for inhalation combination drug product related activities with vendors: formulation and process development for use with device, technical transfer; control strategy build, and implementation; Ensure all DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.

    Review and approval (technical approval) of all analytical data, development reports and protocols, work orders and quotes related to CMC- DP.

    Summarize and present CMC-DP, development plans, activities and outputs to management or other departments in support of product development.

    Responsible for providing CMC-DP and Combination product-related regulatory documents such as product development reports for regulatory filings, inclusive of management, reviewing, updating and authoring.

    Management of CMOs, scientific advisors, regulatory advisors as needed to achieve CMC-DP goals.
    Assisting in defining regulatory strategies both towards FDA, EMA and required markets.
    Provide Leadership and Expertise in Inhalation Drug product development and analysis/testing as an SME in the field.
    Support device regulated development and required DP assistance to device and combination product development activities.
    Provide data interpretation and perform data trending and monitoring using statistical methods as appropriate.
    Support URS and PURs of manufacturing equipment along with supporting installation and process qualification.
    Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).

    Minimum 8 to 10 years' experience as a drug project manager in a pharmaceutical and/or biotech company or CRO.

    Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture.

    Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory.

    Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines.

    Familiar with working in a virtual set-up.
    Fluent in written and spoken professional English.
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