CMC Manager

Job Description

North Leinster

Our client is young ambitious pharmaceutical company with a strong record of success in drug development. The newly appointed CMC Manager will report to the Associate Director – Technical Operations and will manage pharmaceutical development and pharmaceutical technology projects to deliver development pipeline and support existing commercial products. Manage pharmaceutical development projects primarily with respect to validation and commercialization of new products. Manage pharmaceutical technology projects, primarily coordinating continuous improvement activities at CMOs.

Job Spec

· Lead drug product validation and commercialisation activities for new pharmaceutical development projects.

· Lead continuous improvement projects for commercial products

· Support the development and manufacture of pharmaceutical dosage forms and devices.

· Consistent with FDA standards, support the process validation of to-be commercial drug products. In addition, when changes have been made to the manufacture of commercial drug products, support the re-validation of such products.

· Support the technical transfer of commercial manufacturing and analytical testing of drug products.

· Support the preparation of regulatory filings such as INDs, ANDAs, NDAs and supplements.

· Stay current with emerging technology and regulatory guidance within industry.

· Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.

· Support the preparation of the Pharmaceutical Development & Pharmaceutical Technology budget.

· Represent Pharmaceutical Development & Pharmaceutical Technology in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.

· Contribute to the review of company policies and procedures.

· Undertake any other duties, which may be assigned by Senior Management.

LEARNING & DEVELOPMENT

· Actively engage in an individual development / personnel improvement plan.

· Actively engage in the continuous improvement / 5S / 6 sigma programme.

· Ensure training has been received in relation to specific duties.

HUMAN RESOURCE MANAGEMENT

· Adhere to the Company's policies and procedures.

HEALTH & SAFETY

· Understand and follow the company's Health & Safety policies.

· Comply with the environmental management system and minimise environmental impact where possible.

QUALITY

· Comply with all aspects of the Quality System.

· Ensure that a 'quality culture' and an appreciation of the quality system is installed within the manufacturing department.

CORPORATE

· All employees are expected to work towards the company vision and adhere to the core principles of building strong teams of empowered people, communicating effectively, demonstrating trust and respect, developing peoples knowledge and expertise, demonstrating excellence in leadership and exhibiting a positive attitude.

Person Spec

· The preferred candidate will have a degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent at 2.1 or higher master's degree in chemistry or related equivalent PhD in Chemistry or related equivalent

· At least 5 years practical experience of working in pharmaceutical development or manufacturing. At least 2 years practical experience of drug product Process Performance Qualifications and associated activities. Hands on experience is required in the manufacture of drug products, and execution of PPQ / Validation batch manufacture.

· You will have a strong knowledge of ICH, FDA and EMA Process Performance Qualification and Process Validation guidelines, as well as a strong knowledge of ICH, FDA and EMA guidelines relating to Pharmaceutical Development

· 10+ years practical experience of working in pharmaceutical development or manufacturing. At least 5 years practical experience of drug product Process Performance Qualifications and associated activities. Practical experience of packaging Line Trials and Validations. Practical knowledge and experience of drug product Serialization requirements

· Preparation and execution of Process Performance Qualification protocols and reports for Oral Solid Dosage forms. Good knowledge of statistical considerations ie Design of Experiments, ASTM E2709/E2810

· At least 2 years' experience managing pharmaceutical projects at a Contract Manufacturing organisation. Use of DoE methodology in in evaluation and determination of process Design Space and Control Strategies. Experience writing Module 3 Regulatory Submission documentation.

· Demonstrable IT skills ie Office. Knowledge and understanding of statistical software applications ie MiniTab. Proven communication skills (written and verbal). Proven ability to maintain high standards of work and attention to detail. Demonstrable planning, organization and time management skills. Demonstrable ability to work with and influence CMOs.

· Must be able to work individually and as part of a team. Ability to work proactively and under time constraints. Good interpersonal skills

Cv to

PAGE

1