At Blue Earth Diagnostics, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.
The company wishes to appoint a Chemistry Manufacturing and Control (CMC) Manager who will provide oversee CMC development, manufacturing and supply activities with Contract Development and Manufacturing Organisations (CDMOs), related to the development of new chemical entities for Blue Earth Diagnostics. This may include active ingredient and/or finished drug production activities.
Reporting to the Head of CMC, the CMC Manager will be responsible for the management of outsourced CMC project activities on different projects.
Projects will include the manufacturing processes for the various stages of drug development. This includes various development techniques and methods as well and process scale-up and oversight of the activities outsourced to CDMOs – both in the UK and within other European locations.
The post holder will have a high degree of independence and must be able to prioritise their own workload, while working with different stakeholders to advise and support them with their needs.
Responsibilities include the management of third party CDMOs activities, ensuring the accuracy and reliability of the data generated; providing technical expertise and support and adequate scientific interpretation and guidance; securing high quality deliverables in a timely manner; implementing internal and external regulatory guidance; delivering milestones within agreed time, resources and cost; and writing/reviewing relevant CMC-documents such as reports, SOPs and eCTD modules.
Qualifications and Experience:
- Science degree in a chemistry discipline, or a related ﬁeld.
- Minimum of 5 years’ experience in manufacturing and research and development of pharmaceuticals.
- Thorough understanding of industry area including ICH, FDA and EMA guidance relevant to drug development.
- Proven track record with technology transfer, analytical and process validation with small molecules and/or peptides (experience with radiopharmaceuticals or precursors for radiopharmaceuticals is preferred but not essential).
- Experience with the selection, setting up and oversight of CDMOs, related to the manufacture, analysis and/or supply chain of ingredients, intermediates or API.
- Experience with generating CMC content for IND/IMPD and/or module 3 of NDA/MAA applications.
- Experience in Good Manufacturing Practice.
- Experience of project management and proven ability to address challenges and solve problems quickly.
- Experience of working in high performance teams accomplishing objectives in a patient- focused culture.
- Excellent communication and interpersonal skills.
- You will have the innate flexibility to work in a small dynamic company environment.
- You must be prepared to travel worldwide and be able to travel freely within the European Union.
- You must be legally authorised to be employed in the UK.
HOW TO APPLY:
To apply, please submit your CV and a covering letter to firstname.lastname@example.org outlining
- Why this role appeals to you.
- How your background and skills are suited to this role.
Blue Earth Diagnostics offers a highly competitive salary for high-calibre candidates.
Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, colour, religion, sex, national origin or any other characteristic protected by law.
30th Nov 2019