Principal Formulations Chemist

2 days ago

Newry amp Mourne, United Kingdom Life Science Talent Full time

Job Overview


Subject matter expert in the field of Formulation with focus on Early Stage Pharmaceutical

Development. 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. The post holder must ensure that all work is carried out in accordance with the Company’s Quality Manual, Standard Operating Procedures and H&S

requirements as well as those set by regulatory bodies globally. Additionally this role will

mentor and coach formulation chemists to ensure adoption of best practices, including

application of Quality by Design, Design of Experiments, Statistical analysis and support of

pharmaceutical process development


Main Activities


• Lead Early stage Development and optimisation of Pharmaceutical Dosage Forms for Veterinary use, activities to include but not limited to:


• Assessment of API/excipients to identify Critical Material Attributes

• Identification and evaluation of Product Critical Quality Attributes

• Manufacturing Process development and identification and evaluation of Critical Process Parameters and capability of processes and equipment

• Lead Scale up and Tech Transfer of NPD projects into Late stage formulations

• Evaluation and justification of Product in process controls and specifications

• Prepare Pharmaceutical Development reports

• Lead trending of data using an appropriate statistical package to aid investigations and specification setting

• Preparation and support of submission documents and regulatory responses in consideration of (V) ICH guidelines, Ph. Eur., BP monographs and appropriate guidance documents such as CDER

• Mentoring and support of formulation chemists

• Preparation and maintenance of Standard Operating Procedures (SOPs) ensuring that Standard Operating Procedures and Formulation Records are being adhered to at all times

• To assist in the training of Laboratory Staff in SOP’s and operational techniques

• To maintain an awareness of current trends and developing technologies in the manufacture of pharmaceutical dosage forms

• Liaise with staff across R&D and partner groups in Operations and QC to effectively progress new product development and continuous improvement initiative

• Lead technical investigations cross functionally employing problem solving tools

• To ensure adequate stocks of consumables and equipment are available as required

• Maintain clean and safe working environment within the laboratories, following all COSHH and other Health and Safety requirements

• Any other duties as deemed necessary by management



Essential Criteria:


• Degree in in chemistry, analytical chemistry, pharmacy or related subject

• At least 5 years demonstratable experience in formulation/pharmaceutical product development industry or academia

• Experience in the use of QbD principles for pharmaceutical development

• 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 ability to multitask

• Strong problem solving and troubleshooting skills

• Strong communication skills with a demonstrable record of working cross functionally

• Experience of physical test analysis


Desired criteria:


• Masters or PhD in a chemistry related discipline

• Working knowledge of GMP, (V)ICH requirements, FDA/EMA practices and guidelines

• Working knowledge of Bioequivalence

• Experience in new product introduction

• Experience in generating documentation to support the CMC component of regulatory filings

• Experience in the setting of specifications for drug products

• Understanding of statistics and their application to pharmaceutical development


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.

• We are unable to sponsor or take over sponsorship of a Visa at this time.


Benefits:


• Free Life Assurance

• Company Pension – salary sacrifice scheme

• Healthcare cash plan

• 32 days annual leave

• Wedding Leave

• Company Sick Pay

• Company Maternity / Paternity

• Paid bereavement leave

• Cycle to Work Scheme

• Tech Purchase Scheme

• Employee Savings scheme

• Employee well-being initiatives

• Employee Assistance Programme

• On-site free parking

• Subsidised Canteen Facilities

• Employee Perks scheme

• Employee Recognition scheme

• Career development opportunities

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