Formulations Chemist Job Newry area,Northern Ireland UK,Pharmaceutical

Job : LSFC
Job type: Permanent
Location: Newry
Closing date: Wednesday 19 Aug :00
Job Overview
Late-stage development and manufacture of veterinary pharmaceutical dosage forms, from Scale-Up, Technical Transfer, Pre-Approval through to regulatory submission. The holder of the role will utilise quality by design development strategies and adhere to the relevant regulatory requirements set by regulatory bodies globally. 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
Main Activities

Development and optimisation of Pharmaceutical dosage forms for veterinary use
Development and optimisation of manufacturing processes for routine manufacture of various pharmaceutical dosage forms employing Quality by Design principles
Provide support for remediation/Continuous Improvement efforts for existing products
Perform physical and chemical analysis and assessments of API and drug product for new and existing projects
Assist with reverse engineering of commercial products
Support Development of product specifications for new products
Prepare Pharmaceutical Development reports in support of Regulatory submissions
To ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required
Preparation and maintenance of Standard Operating Procedures (SOPs) and ensuring SOPs and Formulation Records are being adhered to at all times
Maintenance of accurate records, preparation of protocols and reports for both group and R&D management.
To assist the regulatory affairs department in responses to regulatory bodies related to pharmaceutical development to ensure successful submission of new products.
To ensure adequate stocks of consumables are available as required
Other duties as requested by management

Essential Criteria:
Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

Bachelor's Degree or higher in a chemistry or pharmacy related discipline
At least 1 years hands on experience of drug product development and/or manufacture
Excellent computer skills including Microsoft Office suite
Working knowledge of GMP and (V)
ICH requirements

Desirable Criteria:
Due to the nature of the role preference will be given to applicants demonstrating the following desirable criteria:

Post Graduate Qualification in a chemistry or pharmacy related discipline
Experience of supporting ANDA regulatory submission
Experience of Quality by Design
Use of statistical software e.g. Minitab

Duration :
Full time, Permanent
Location :
Newry
Additional Information:

This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted.

Benefits :

Free Life Assurance
Company Pension Scheme
Healthcare cash plan
31 days annual leave
Wedding Leave
Company Sick Pay
Employee well-being initiatives
Employee Assistance Programme
On-site free parking
Canteen Facilities
Employee Perks scheme
Discounted Car Insurance
Annual Employee raffle
Employee Recognition scheme
Career development opportunities

To Apply Please forward your CV via the APPLY Now button below.