Position 

Job title: Analytical Development – Characterisation Specialist

Department :  Biologics Development

Line Manager: Andrew Splevins, CMC Manager

Purpose of the position

Analytical characterisation of novel Biologic products and bioprocesses, as part of the CMC Team (within the Biologics Development group) based in Milton Park, Oxford (Ipsen Bioinnovation site).

Main responsibilities and tasks

Main Responsibilities

Main Tasks

  • Responsibility 1
  • Support the analytical characterisation of novel Biologic products and bioprocesses, as part of the Biologics Development group at Ipsen, Milton Park.
  • Elucidate the structure, modifications, critical quality attributes and degradation pathways of biologic products through the development and implementation of protein characterisation methods including size, charge and hydrophobicity-based separation techniques e.g. HPSEC, IEX, RPHPLC, HIC, cIEF, CE
  • Provide critical support to bioreactor, purification and formulation development through the development and implementation of bioprocess analytical methods including product titre assays, analytical chromatography methods, cIEF/CE immunoassays, and other high throughput/automated physico-chemical methods
  • Responsibility 2
  • Support method transfer and qualification/validation where required
  • Effectively plans and performs analytical work, including protocol and report preparation, data review, trending and tracking, to required quality standards in support of pre-clinical and clinical development study requirements and product lifecycle development
  • Support multiple analytical programs with strong co-ordination of workload to deliver key Biologics Development and lifecycle management projects on time
  • Work as a flexible team member of a small analytical team to provide agile support across varied workstreams
  • Responsibility 3
  • Maintain high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences
  • Build the culture and the science by increasing product knowledge (molecular/quality attributes) through good quality, impactful analytical communications and presentations
  • Foster stronger partnerships and collaborative working across Biologics Development teams at both Milton Park and Wrexham sites,  Global Drug Discovery, R&D and support external relationships (CRO, CMO, academic and industry collaborations) to strengthen scientific and technical expertise and enable AD toolbox expansion
  • Support improvements to ADev. systems and processes
  • Seek opportunities to boost productivity/efficiency
  • Responsibility 4
  • Support implementation of expanded Analytical facilities
  • Meet all aspects of EHS Compliance (staff safety, environmental impact and EHS legislative compliance), Quality Management System (QMS), and internal/external Regulatory requirements.

Experience / Qualifications

  • Experience &  Qualifications:

 

-Ideal: PhD level (or equivalent), with relevant Biopharmaceutical R&D industry experience in analytical approaches for Biologic product and/or bioprocess characterisation

-Minimum:   BSc (Hons) level with relevant further experience

Required Competencies

Technical Competencies

 

  • Good understanding and experience of analytical characterisation of products and/or bioprocesses, with competence in a number of the separation techniques described above
  • Biopharmaceutical R&D industry experience working in technical team(s) supporting product bioprocess analytical techniques described above
  • Knowledge and technical capabilities in assay development, implementation, qualification and testing for biologic products, most notably in mass spectrometry of proteins
  • Track record of working in diverse and multi-cultural technical teams, advancing technical areas of responsibility through cross-functional working and maintenance of scientific literature awareness and competency
  • Desire to learn new product characterisation techniques (e.g. liquid chromatography mass spectrometry methods and biophysical techniques)
  • Ability to present and articulate complex technical topics to technical and non-technical stakeholders across Biologics Development
  • Knowledge of regulatory submissions, briefing documents and CMC documentation, as required, to ensure the successful approval of new products

Ipsen Key Competencies

(select the key competencies which are most relevant to the position)

The Key Competencies

Short definition

(more details in the framework)

X

 

Lives Ipsen ethics

 

Understands and actively supports the company’s mission, acts in accordance with its values and its ethical code of conduct and contributes to ensuring Ipsen’s reputation both inside and outside the company

 

X

Demonstrates a broad vision

Steps back and develops a broad, comprehensive and long-term vision of his/her area of activity, sets out a strategy and translates it into concrete action, in order to differentiate Ipsen and give it Key competitive advantages

 

Drives execution

Identifies the resources and indicators required for implementing and managing projects and action plans, gathers relevant information and takes appropriate decisions within a suitable timescale ensuring objectives are achieved

 

X

 

Drives accountability

 

Strives to assume his/her responsibilities when conducting his/her activities, is personally committed and takes responsibility for his/her performance

 

X

Displays leadership

Strives to emphasize his/her ideas and their added value for Ipsen, establishes and maintains an environment that encourages committed and motivated employees, influences and drives ideas and behaviors, leads the way in developing collective efficiency

 

Fosters team work

Acts as a good team player, establishes an atmosphere that promotes the exchange of ideas and encourages individuals to express themselves, develops collaborative approaches and encourages team work

 

X

 

Strives for excellence

 

Clearly and ambitiously defines the results and standards to be reached

And does everything possible to exceed expectations, thus improves the company’s results

 

X

Ensures continuous customer focus

Actively listens to customers (end customer, internal or external partners) with the aim of detecting their needs, takes these into account as best as possible in short term and medium term actions and to guarantee a high standard of quality of service

 

X

Fosters innovative organization

Creates an environment that encourages the development of an entrepreneurial spirit, promotes creativity and the emergence of new ideas, and supports the implementation of highly innovative systems or approaches within the company

 

X

Promotes a nimble organization and demonstrates agility

Sets the path for change and implements it, creates conditions that will motivate players and staff with a view to simplifying both processes and the organization and aligning them with the group’s strategy

 

Other Useful Information

  • Specifics of the position: As described above
  • Internal and external contacts (organisation): As described above
  • Financial impact: Support budget management
  • People management: NA