Drug Product Process Development Specialist Jobs Vacancy at Ipsen Wrexham
Ipsen Wrexham urgently required following position for Drug Product Process Development Specialist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Drug Product Process Development Specialist Jobs Vacancy at Ipsen Wrexham Jobs Details:
We are currently recruiting for a Drug Product Process Development Specialist to join our Drug Product Process & Delivery Team. This position is permanent and based at our Wrexham site and reports directly to the Drug Product Process & Delivery Team Leader.
Ipsen is a rapidly growing company with sales growth of 21.1% which in turn is supporting investment into the Ipsen Wrexham site totalling c.£100m over the next 5 years. Ipsen Wrexham aims to become ‘the Best at Improving People’s Lives’ and this is reflected in ambitious plans with targets to become a flagship site for multiple business areas, in turn transforming Ipsen Group global initiatives.
The successful applicant will be able to work independently or in collaboration with other and will provide leadership when leading complex project with large cross-functional teams. They will have the ability to convey information clearly, writes fluently in a clear and concise manner and able to influence audience with confidence. The candidate will also be able to provide effective and regular reporting and presentation of Development strategies and results.
Main Duties & Responsibilities
The Drug Product Process Development Specialist will be responsible for designing Drug Product plans and strategies for manufacturing process and Drug Product development throughout clinical phases to commercialisation. They will independently lead Drug Product/Fill Finish development programs which define robust drug product manufacturing processes and develop understanding of Drug Product attributes. Whilst also representing the Drug Product Development team on CMC project teams to advance product development. Actively supports CMC project teams at all stages of product development.
Further duties will include:
- Independently leads complex programs of work required within Drug Product Development to define manufacturing process and develop understanding of Drug Product attributes.
- Capable of leading technical project workstreams.
- Have a broad understanding of CMC activities, understand risks and be able to link actions to Drug Product Development.
- Writes and executes protocols and plans required within Drug Product Development to define manufacturing process and develop understanding of Drug Product attributes.
- Design appropriate studies utilising QbD principles and GMP understanding. Defines Critical Process Parameters (CPPs), Design Space and Manufacturing Control Strategies.
- Works without appreciable direction to meet project goals.
- Able to perform technical/critical review of data for drug product development studies and reports.
- Ensures effective communication with internal and external GMP manufacturing partners.
- Ensure training on analytical methods and equipment use is up to date and appropriate to support development activities.
- Analyse raw data from multiple sources to enable rational conclusions to be drawn and provide appropriate recommendations.
Skills, Experience & Education
Ideal: PhD in appropriate scientific discipline with industrial experience in a relevant role. cGMP experience gained from a manufacturing environment.
Minimum: Degree level in a relevant discipline with 5-8 years industrial experience.
IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.