Scientist - Product Development Specialist
2 days ago
Ethypharm, a 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:
General Activities:
- Stay up-to-date with new ingredients and processes to support new development projects.
- Coordinate pilot plant housekeeping, equipment qualification, and maintenance activities.
Projects:
- Develop robust formulations for various sterile and non-sterile liquid dosage forms, including oral liquids, PFS, vials, and ampoules.
- Design and execute formulation and process development protocols adhering to QbD and DoE principles.
- Maintain accurate records of lab manufacturing activities and ensure critical data are reported according to cGMP standards.
- Ensure availability of raw materials and equipment prior to batch manufacture.
- Perform process development studies from batch sizes ranging from 500mL to 200L to deliver a process that meets requirements.
- Write high-quality technical documents (BMR, Protocols, Reports) to support license submissions or product validation, according to cGXP and regulatory requirements.
- Support the introduction, qualification, and maintenance of pilot plant equipment, ensuring activities are captured according to quality and regulatory requirements.
- Oversee manufacture/scale-up activities for new projects in our commercial facility.
- Support development studies required for marketing authorization of new products.
Additional Responsibilities:
- Prioritize formulation and process development activities 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.
- Participate 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 risk assessments.
About You:
- Excellent time management and prioritization skills.
- Strong communication, decision-making, and organizational 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 with new equipment introduction and qualification.
- Knowledge of liquid formulation excipients and their functions.
Ethypharm values diversity in the workplace and provides equal opportunities for all. We are open to discussing flexible working arrangements that meet our business needs.
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