Senior Scientist

4 weeks ago

Romford, Greater London, United Kingdom Ethypharm Full time
Senior Scientist - Formulation and Process Development

Ethypharm, a leading European pharmaceutical company, is seeking a highly skilled Senior Scientist to join our Product Development team. As a key member of our team, you will be responsible for the formulation and process development of new sterile and non-sterile pharmaceutical products, ensuring they meet the highest quality and regulatory standards.

The successful candidate will be based out of our manufacturing site in Romford and will report to our Head of Product Development. You will work closely with our cross-functional teams to develop and implement new product formulations and processes, ensuring seamless integration with our manufacturing operations.

Main Responsibilities:

General Activities:

  1. Develop and maintain a deep understanding of new ingredients and processes to support new development projects.
  2. Coordinate pilot plant housekeeping, equipment qualification, and maintenance activities to ensure optimal performance.

Projects:

  1. Design and manufacture lab-scale trial batches for development of robust formulations for various sterile and non-sterile liquid dosage forms.
  2. Develop formulation and process development protocols adhering to latest QbD and DoE principles under the guidance of our Head of Product Development.
  3. Maintain accurate records of lab manufacturing activities and ensure critical data are reported as per cGMP standards.
  4. Ensure availability of raw materials and equipment prior to manufacture of batches.
  5. Perform process development studies from batch sizes ranging from 500mL to 200L to deliver a process that meets our quality and regulatory requirements.
  6. Write high-quality technical documents (BMR, Protocols, Reports) to support license submissions or product validation, according to cGXP and specific regulatory requirements.
  7. Support introduction, qualification, and maintenance of pilot plant equipment, ensuring these activities are captured as per quality and regulatory requirements.
  8. Oversee manufacture/scale-up activities for new projects in our commercial facility.
  9. Support development studies required for marketing authorization of new products.

Additional Responsibilities:

  1. Prioritize formulation and process development activities under the guidance of our line manager to meet project timelines.
  2. Work with our Senior Analysts to coordinate lab activities.
  3. Perform and coordinate development activities according to cGXP and internal SOPs.
  4. Lead or support team members with OOS, OOT, or analytical investigation in their area of expertise.
  5. Take part in change control/process or product investigations/CAPA in their area of expertise.
  6. Write or amend SOPs within their area of expertise.
  7. Support H&S and promote safe working practices by performing appropriate risk assessments.

About You:

  1. Excellent time management and prioritization skills.
  2. Strong communication, decision-making, and organizational skills.
  3. Positive mindset, ethical, and pragmatic approach.
  4. Team player with ability to work with remote colleagues and diverse cultures.

Requirements:

  1. BSc in Pharmaceutical Science or equivalent.
  2. At least 3-5 years of hands-on experience in formulation/process development gained within the pharmaceutical industry.
  3. Experience of new equipment introduction and qualification.
  4. Must have experience in formulation and process development of oral solutions/suspension, with good knowledge of liquid formulation excipients and their functions.

Ethypharm values diversity and provides equal opportunities for all. We are open to discussing flexible working arrangements that meet our business needs.

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