CMC Manager

Our client is a 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 the development pipeline and support existing commercial products. Responsibilities include:

1. Lead drug product validation and commercialization activities for new pharmaceutical development projects.
2. Lead continuous improvement projects for commercial products.
3. Support the development and manufacture of pharmaceutical dosage forms and devices.
4. Support the process validation of to-be commercial drug products consistent with FDA standards, and re-validation when changes are made.
5. Support the technical transfer of commercial manufacturing and analytical testing of drug products.
6. Support the preparation of regulatory filings such as INDs, ANDAs, NDAs, and supplements.
7. Stay current with emerging technology and regulatory guidance within the industry.
8. Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical, and Pharmacovigilance.
9. Support the preparation of the Pharmaceutical Development & Pharmaceutical Technology budget.
10. Represent Pharmaceutical Development & Pharmaceutical Technology in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
11. Contribute to the review of company policies and procedures.
12. Undertake any other duties assigned by Senior Management.

LEARNING & DEVELOPMENT

1. Actively engage in an individual development/personal improvement plan.
2. Actively engage in the continuous improvement / 5S / 6 sigma programme.
3. Ensure training has been received in relation to specific duties.

HUMAN RESOURCE MANAGEMENT

Adhere to the Company's policies and procedures.

HEALTH & SAFETY

1. Understand and follow the company's Health & Safety policies.
2. Comply with the environmental management system and minimize environmental impact where possible.

QUALITY

1. Comply with all aspects of the Quality System.
2. 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 people's knowledge and expertise, demonstrating excellence in leadership, and exhibiting a positive attitude.

Person Spec

1. The preferred candidate will have a degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent at 2.1 or higher; a master's degree in chemistry or related equivalent; or a PhD in Chemistry or related equivalent.
2. At least 5 years practical experience in pharmaceutical development or manufacturing, with at least 2 years in drug product Process Performance Qualifications and associated activities.
3. Hands-on experience in the manufacture of drug products and execution of PPQ / Validation batch manufacture.
4. Strong knowledge of ICH, FDA, and EMA Process Performance Qualification and Process Validation guidelines, as well as guidelines relating to Pharmaceutical Development.
5. 10+ years practical experience in pharmaceutical development or manufacturing, with at least 5 years in drug product Process Performance Qualifications and associated activities.
6. Practical experience of packaging Line Trials and Validations, and knowledge of drug product Serialization requirements.
7. Preparation and execution of Process Performance Qualification protocols and reports for Oral Solid Dosage forms, with good knowledge of statistical considerations (e.g., Design of Experiments, ASTM E2709/E2810).
8. At least 2 years' experience managing pharmaceutical projects at a Contract Manufacturing organization, with experience in DoE methodology for process Design Space and Control Strategies.
9. Experience writing Module 3 Regulatory Submission documentation.
10. Demonstrable IT skills (e.g., Office) and knowledge of statistical software applications (e.g., MiniTab).
11. Proven communication skills (written and verbal) and ability to maintain high standards of work and attention to detail.
12. Demonstrable planning, organization, and time management skills, with the ability to work with and influence CMOs.
13. Must be able to work individually and as part of a team, proactively and under time constraints, with good interpersonal skills.