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Hays Specialist Recruitment Limited
Cardiff
Your new company A top 35 award-winning practice is relocating to Cardiff to establish a new Tax Centre of excellence. This presents an outstanding opportunity to work in a firm with an excellent reputation across the South West. They manage a diverse client base and excel in terms of client quality.They are looking for an experienced Tax Advisory
Job Source: Hays Specialist Recruitment LimitedReed Technology
Newport
Job Title: Product Manager Location: Newport (1 day per week) About the Role: They're part-way through an ambitious, five-year plan to completely transform the business and how they interact with our customers. We have developed a suite of ground-breaking digital products that are ready to release to our customers and we are approaching phase two
Job Source: Reed TechnologyIndependence Products Ltd
Usk, Wales, United Kingdom
Product Manager UK Working Pattern : This is a full-time role. The successful candidate will work from our office in Usk, Monmouthshire 50% of their time, with the rest of their time spent with customers and the salesforce in the field and from their home office. As such, the successful candidate will need to be located within a sensible commuting
Job Source: Independence Products LtdFMC Talent
Wales, United Kingdom
Do you have a passion for shaping the market and changing the standard of minimally invasive surgery? Following recent growth, our client is searching for a Product Manager to help shape the future approach of the company. A bit about the company and what they can offer you Our client focuses on providing dynamic solutions to help treat chronic co
Job Source: FMC TalentThe Telegraph
Newport, Wales, United Kingdom
About the role We're looking for a highly creative, self-motivated and experienced Designer to join a multidisciplinary team working across our digital bespoke editorial and special projects as part of the Product Design team, as part of your role you will lead projects and mentor other designers. Working closely with Lead Designers and the Design
Job Source: The TelegraphNinetech
Cardiff
My client, a digital consultancy, are looking to add a Product Manager to the team on an initial 6 month basis. The role requires experience within GDS. The role is paying £450 P/D This position requires 2 days a week on site in Cardiff and is OUTSIDE of IR35 The role requires someone with GDS experience and knowledge of leading digital transformat
Job Source: NinetechRGB Recruitment
Cardiff
Associate Director – Civil Cardiff £65,000 - £80,000 We have the fantastic opportunity to join a rejuvenated Engineering consultancy in South Wales, who are looking for a Civils lead to help run the business. Covering Civil and Structural Engineering, they have recently started a new business plan which entails strong Civils growth. You would
Job Source: RGB RecruitmentRGB Recruitment
Cardiff
Associate Director – CivilCardiff£65,000 - £80,000We have the fantastic opportunity to join a rejuvenated Engineering consultancy in South Wales, who are looking for a Civils lead to help run the business.Covering Civil and Structural Engineering, they have recently started a new business plan which entails strong Civils growth.You would be managin
Job Source: RGB RecruitmentWales, United Kingdom
Drug Product Senior Manager / Associate Director
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 Europe, the UK or the US.
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 [email protected] / ++353 (0) 1 2302400
Email Alert for Drug Product Senior Manager / Associate Director jobs in Wales, United Kingdom
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