Scientist - Product Development Specialist
9 hours ago
Ethypharm, a European pharmaceutical company, is seeking a highly skilled Senior Scientist to join its Product Development team. As a key member of the 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 the pilot plant.
The ideal candidate will have a strong background in pharmaceutical science and at least 3-5 years of hands-on experience in formulation/process development within the pharmaceutical industry. You will be responsible for maintaining good knowledge of new ingredients and processes, coordinating pilot plant housekeeping, and ensuring the availability of raw materials and equipment prior to manufacture.
Main Responsibilities:
General Activities:
- Develop and maintain a deep understanding of new ingredients and processes to support new development projects.
- Coordinate and manage pilot plant housekeeping, equipment qualification, and maintenance activities.
Projects:
- Design and execute formulation and process development protocols adhering to latest QbD and DoE principles.
- Develop and manufacture lab-scale trial batches for development of robust formulations for various sterile and non-sterile liquid dosage forms.
- Write high-quality technical documents (BMR, Protocols, Reports) to support license submissions or product validation, according to cGXP and specific regulatory requirements.
- Support the 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 to meet project timelines.
- Work collaboratively with the 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 time management and prioritization skills.
- Strong communication, decision-making, and organization skills.
- Positive mindset, ethical, and pragmatic.
- Team player, able to work with remote colleagues and diverse cultures.
Requirements:
- BSc in Pharmaceutical Science or equivalent.
- At least 3-5 years of hands-on experience in formulation/process development within the pharmaceutical industry.
- 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 dynamic and supportive work environment, and we are committed to providing opportunities for professional growth and development.
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