Job title:
Technical Lead (Analytical SME)
Company
Norbrook Laboratories
Job description
Job Description:To lead and provide technical support to the pharmaceutical development team in relation to the design, execution and reporting of reverse engineering studies for new products in accordance with current guidelines.
This is a lab-based role and is expected to be a subject matter expert in analytical method development/validation and be aware of all current guidelines within this field in specific EMA and FDA guidelines.
Working in a diverse team of scientists developing a wide range of Pharmaceutical Dosage Forms including but not limited to, oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical suspensions and solutions, and intra-mammary preparations.
Ensure that all work is carried out in accordance with the Company’s Procedures and H&S requirements.Main Activities/Tasks
- Lead the design and execution of reverse engineering studies to support the development process for pharmaceutical equivalence projects
- Develop and validate analytical methods, where required, to support reverse engineering studies in accordance with the relevant guidelines
- Lead and support the development and validation of dissolution studies within the department.
- Provide technical support to the pharmaceutical development team to aid in troubleshooting of analytical methods.
- Compile and review protocols and reports in line with both industry standard and company procedures.
- Support the preparation of documentation and responses to regulatory submissions and queries
- Maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for reverse engineering studies, dissolution studies, method development and validation, and where appropriate cascade training to the pharmaceutical development team for changing trends.
- Lead/participate in project meetings as required.
- Provide technical input and evaluation for the establishment of specifications for new products
- Identify and implement continuous improvements within the pharmaceutical development department
- Ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required.
- Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations
- Any other duties as deemed necessary by Management
Essential Criteria:
- Bachelor’s Degree in a chemistry, analytical or pharmacy related discipline
- At least 5 years relevant, post graduate qualification, experience in a pharmaceutical development role.
- Extensive experience in the development and validation of methods for APIs and excipients in finished products using a wide range of techniques UPLC, GC, size exclusion chromatography as well as wet chemistry
- Expertise in dissolution method development/application.
- Experience in the field of Reverse Engineering
- Excellent computer skills including Microsoft Office suite in particular ability to trend data using an appropriate statistical package e.g. Minitab, Excel
- Enthusiastic and hard-working individual, highly motivated to achieve technical targets with an ability to multitask
- Strong problem solving and troubleshooting skills .
- Strong communication skills with a demonstrable record of working as a team and cross-functionally
Desirable Criteria:
- Masters or PhD in Chemistry, pharmaceutical sciences
- Working knowledge of GMP and (V)ICH requirements
- Knowledge/Experience of Mass spectrophotometry, NMR,
- Experience of supporting ANDA regulatory submission
- Ability to critically review scientific literature.
- Excellent report writing and presentation skills
- Working knowledge of Quality by Design principles
Expected salary
Location
Newry
Job date
Sat, 12 Oct 2024 01:18:14 GMT
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