Scientist - Product Development Specialist

4 weeks ago

Romford, Greater London, United Kingdom ZipRecruiter Full time
Job Description

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, as well as supporting the introduction and qualification of new equipment for our pilot plant.

Main Responsibilities:
  • Develop and maintain good knowledge of new ingredients and processes to support new development projects.
  • Coordinate pilot plant housekeeping, equipment qualification, and maintenance activities.
Key Projects:
  • Manufacture of lab-scale trial batches for development of robust formulations for various sterile and non-sterile liquid dosage forms.
  • Design formulation and process development protocols adhering to latest QbD and DoE principles under the guidance of the Head of Product Development.
  • Maintain accurate records 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 sizes ranging from 500mL to 200L to deliver a process that fits for purpose.
  • Write high-quality technical documents (BMR, Protocols, Reports) to support license submissions or product validation, according to cGXP and specific regulatory requirements.
  • Support introduction, qualification, and maintenance of pilot plant equipment, ensuring that these activities are captured as per quality and regulatory requirements.
  • Oversee manufacture/scale-up activities for new projects in commercial facilities.
  • Support development studies required for marketing authorization of new products.
Additional Responsibilities:
  • Prioritize formulation and process development activities, under the guidance of the line manager, to meet project timelines.
  • Work with Senior Analysts to coordinate 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 their area of expertise.
  • Take part in change control/process or product investigations/CAPA in their area of expertise.
  • Write or amend SOPs within their area of expertise.
  • Support H&S and promote safe working practices by performing appropriate risk assessments.
About You:
  • Excellent written and oral communication skills in English.
  • Good time management and ability to prioritize workload.
  • Proven competence in standard IT systems, e.g., Microsoft Windows, Microsoft Office, Internet Browsers.
  • Excellent time management, communications, decision-making, and organization skills.
  • Positive mindset, ethical yet pragmatic.
  • Team player, able to work with remote colleagues and diverse cultures.
Requirements:
  • BSc in Pharmaceutical Science or equivalent.
  • 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 and qualification.
  • Must have experience in the formulation and process development of oral solutions/suspension. Good knowledge of liquid formulation excipients and their functions.

Ethypharm is an equal opportunities employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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