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Senior Scientist

5 months ago

Romford Greater London, United Kingdom Ethypharm Full time

Ethypharm is a European pharmaceutical company whose mission is to improve patients’ lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.

The role of the Senior Scientist is based out of our manufacturing site in Romford and will be reporting to our Head of Product Development.

In this role you will be responsible for the formulation and process development for the new sterile and non-sterile pharmaceutical products and to support any formulation/process changes associated with the existing products. You will also support the introduction and qualification of new equipment for the pilot plant with support from other NPD members.

Main responsibilities:

General activities:

  • Maintain good knowledge of new ingredients and processes to support new development projects
  • Coordinate pilot plant housekeeping, equipment qualification and maintenance activities

Projects:

  • Manufacture of lab scale trial batches for development of robust formulations for various sterile and non-sterile liquid dosage forms i.e. oral liquids, PFS, vials and ampoules.
  • Design formulation and process development protocols adhering to latest QbD and DoE principal under the guidance of Head of Product Development.
  • Maintain accurate record of lab manufacturing activities and ensure that critical data are reported as per cGMP standards.
  • Ensure availability of raw materials and equipment prior to manufacture of batches.
  • Perform process development studies from batch size ranging from 500mL to 200L to deliver a process that fit for purpose.
  • Write high quality technical documents (BMR, Protocols, Reports), to support license submissions or product validation, according to cGXP and specific regulatory requirements (MHRA, EMA and FDA).
  • Support introduction, qualification, and maintenance of pilot plant equipment, ensuring that these activities are capture as per quality and regulatory requirements.
  • Oversee manufacture/scale-up activities for new projects in commercial facility.
  • Support development studies required for marketing authorization of new products.

Additional Responsibilities:

  • Prioritize formulation and process development activities, under the guidance of his/her line manager, to meet project timelines.
  • Work with the Senior analysts to co-ordinate lab activities.
  • Perform and coordinate development activities according to cGXP and internal SOPs.
  • Lead or support team members with OOS, OOT, or analytical investigation in his/her area of expertise.
  • Take part in change control / process or product investigations / CAPA /… in his/her area of expertise.
  • Write or amend SOPs within his/her area of expertise.
  • Support H&S and promote safe way of working by performing appropriate risk assessments.

About you:

  • Good English written/oral communication.
  • Good time management & able to priorities workload.
  • Proven competence in standard IT systems e.g., Microsoft Windows, Microsoft Office, Internet Browsers.
  • Excellent time management, communications, decision-making, and organisation skills.
  • Positive mindset, ethical yet pragmatic.
  • Team player, able to work with remote colleagues and diverse cultures.

Skills/Education:

  • You should have a BSc in Pharmaceutical Science or equivalent.
  • Have at least 3 to 5 years of hands-on experience in formulation/process development gained within the pharmaceutical industry.
  • Gained experience of new equipment introduction & qualification.
  • Must have experience in the formulation and process development of oral solutions/suspension. Good knowledge of liquid formulation excipients and their functions.

At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business. Visit our website at to learn more about Ethypharm.