Our client is an exciting, rapid growing publicly listed clinical stage biopharmaceutical business focussed on establishing best in class teams across all its functions. In 2021, the company successfully completed an IPO on the Nasdaq. To date, the company has raised $300 million +, and is engaged in a major expansion of its team in Ireland.
The main task of the Drug Product, Senior Manager / Associate Director 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 Ireland, Europe, or the UK.
Job Spec
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; scale-up; control strategy build, and implementation; PPQ.
Ensure all DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
Develop and control appropriate budgets and timelines for the delivery of CMC-DP in line with company goals.
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.
Liaise with other CMC functions including Drug Substance, Analytical and Engineering/Device to provide technical support in establishment of specifications and analytical methodology. 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).
Develop knowledge and create IP opportunities for the portfolio.
Person Spec
Minimum 8 to 10 years' experience as a drug project manager in a pharmaceutical and/or biotech company or CRO.
Experience on CMC documentation for respiratory devices is important.
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.
Updated knowledge of ICH GMP is required.
Excellent communication, presentation, and interpersonal skills.
Self-driven and motivated team player.
Familiar with working in a virtual set-up.
Fluent in written and spoken professional English.
CV to Gerry Kennedy at ****** / ++353 (0) 1 2302400
#J-18808-Ljbffr