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Formulations Chemist

Posted 22/10/2024

Negotiable

Newry

Permanent

Science, Pharma & Food

Job Description

MCS Group is looking for Formulation chemists to join our client's team to contribute to the development of innovative pharmaceutical dosage forms.

In this role, you'll take a pharmaceutical product from its target profile through prototype manufacture, all while ensuring a smooth technology transfer to manufacturing. You will apply Quality by Design (QbD) principles, adhering to global quality standards, including VICH guidelines.

Key Responsibilities:

  • Develop and optimise various pharmaceutical dosage forms for veterinary use, such as oral tablets, sterile injectables, topical solutions, and intra-mammary preparations.
  • Identify and evaluate Product Critical Quality Attributes (CQAs) through risk assessments.
  • Conduct manufacturing process development and optimisation, focusing on Critical Process Parameters (CPPs).
  • Assess the Critical Material Attributes of active pharmaceutical ingredients (APIs) and excipients.
  • Support the scale-up and technology transfer of new product development (NPD) projects into operations.
  • Perform laboratory-based manufacturing and analysis to drive formulation and product development.
  • Prepare and support regulatory submission documents in line with (V)ICH guidelines, Ph. Eur., BP, and USP monographs.
  • Lead the preparation of Pharmaceutical Development reports for regulatory submissions.
  • Maintain accurate records and prepare protocols and reports for management.
  • Create and maintain Standard Operating Procedures (SOPs), always ensuring compliance.
  • Train and mentor laboratory staff on SOPs and manufacturing processes.
  • Collaborate with R&D, Operations, and QC teams to advance new product development and continuous improvement initiatives.

About You:

  • Bachelor's degree in chemistry, Pharmacy, or a related field.
  • 3+ years of experience in formulation and product development within industry or academia.
  • Strong computer skills, particularly with Microsoft Office and data analysis tools like Mini tab or Excel.
  • Highly motivated, enthusiastic, and capable of multitasking to achieve technical targets.
  • Excellent problem-solving and troubleshooting skills.
  • Strong communication skills with a proven ability to work collaboratively in teams.
  • Experience in physical test analysis.

Desirable Skills:

  • Master's or PhD in Pharmaceutical Sciences.
  • Knowledge of GMP and VICH requirements.
  • Experience with new product introductions and supporting ANDA regulatory submissions.
  • Familiarity with Quality by Design principles.

What's in it for you?

  • Competitive salary (DOE)
  • Subsidised Canteen
  • Discount on car insurance
  • 32 days of Annual Leave
  • Life Assurance
  • Company Pension Scheme
  • Health care Cash Plan
  • Development and growth opportunities
  • On-site free car parking... and many more benefits
    Full details will be provided upon application.

To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Amy Wallace, Specialist Consultant at MCS Group 028 9049 0898

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs

All conversations will be treated in the strictest of confidence.

Not all agencies are the same… MCS Group is passionate about providing a first-class service to all our customers and has an independent review rating of 4.9 stars on Google.

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