Opportunities for permanent roles in a range of business sectors

CMC Associate - competitive salary & benefits package

Are you a team player with excellent communication and planning skills?  Would like to join a dynamic and innovative company that is seeking to advance medicines through creative formulation science?

Arecor is looking to recruit a CMC Associate who will be responsible for supporting the product team with CMC related activities at Arecor.   

We are a formulation technology leader having developed an innovative and proprietary formulation technology platform to enable superior biopharmaceutical products. This technology platform is applied to partner’s proprietary products under a licensing model and to Arecor’s product portfolio.   Our proprietary portfolio includes our first franchise in diabetes, which Arecor has taken into clinical development, and a second franchise in anti-infectives.

This role offers the opportunity to support the team in managing GMP manufacturing, quality analysis and stability program of Arecor’s franchise products.

You must be confident and able to drive and maintain Arecor’s CMC activities. Interactions with internal and external partners are key, so you will be skilled in relationship and project management and possess excellent communication skills, both written and oral.

To apply for this role, please send your CV and a covering letter, outlining why you should be considered for this role.

STRICTLY NO AGENCIES – Thankyou

 

Broad Function

To perform general duties and support CMC related activities within the relevant section of the development department.

 

Principal Responsibilities:

  • Day to day management of external contract development and manufacturing organisations (CDMO) associated with the manufacture, fill and finish, analysis and stability of Arecor’s franchise products as required.
  • Manage external CROs to develop analytical methods, for process critical checks associated with the manufacture, release and stability of Arecor franchise products.
  • Provide support as required for QA activities, such as deviations, change controls, out of specification etc associated with the manufacture, release and stability of Arecor franchise products.
  • Support SMEs in setting release and shelf-life specification for Arecor franchise products.
  • Manage and oversee ICH stability studies for Arecor franchise product.
  • Represent Arecor at project team meetings
  • Report data to the standards expected by Arecor and associated stakeholders.
  • Ensure all activities follow standard operating procedures and/or protocols as required.
  • Work with other departments to resolve issues and implement corrective actions.
  • Ensure all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with the highest quality.
  • Carry out other reasonable tasks as required by the line manager.

Principal Relationships

 

  • Accountable to line manager.
  • Liaise with internal personnel at all levels of the business as required.
  • Liaise with external third parties as required.

Education & Experience

 

  • A BSc, or MSc or PhD in Life Sciences or equivalent
  • Experience of working within the pharmaceutical industry or related discipline, with in-depth drug product development and manufacturing knowledge and expertise.
  • Experience of setting up, managing and analysing ICH stability studies for drug products.
  • Experience in the development of drug product manufacturing processes from laboratory to clinical.
  • Experience in the regulatory and quality environment and associated guidelines as required for the development and manufacture of pharmaceutical and biopharmaceutical drug substances and drug products.
  • Recent experience of working in a laboratory setting.

 

Skills & Attributes

  • Communication, planning, team working and organisational skills are essential.
  • Adapts style of communication to meet the needs of the audience and shares information with colleagues.
  • An effective member of cross-functional teams or projects.  Responds positively to team goals and works towards them, liaising with others to ensure plans remain on schedule.
  • Identifies current problems quickly and accurately and recognises the need for solutions without being prompted.
  • Consistently meets or manages deadlines.  Deals positively with change and is able to highlight where changes in own plans will affect others or overall operational plans.
  • Asks questions to check own understanding of requests and actively listens and responds appropriately.
  • Carefully follows all steps of procedures to complete all assigned tasks with accuracy and consistency.
  • Knowledge of methods and processes used to conduct a systematic and objective analysis and reporting of results.
  • Analyses project requirements, assigns resources effectively, monitors implementation and delivers results in line with project goals.
  • Strong IT skills, including Microsoft Word, Excel, Outlook and PowerPoint