Director Formulation Development

Job Summary:

Manage and direct formulation and manufacturing process development activities according to set project objectives. Leadership role for the development, implementation, evaluation and maintenance of comprehensive and effective product development programs that comply with regulatory requirements. 

Duties and Responsibilities:

• Managing all activities related to the formulation development and manufacturing process development of new products and all the activities related to improving existing products using appropriate scientific approaches according to regulatory standards.
• Guiding the formulation team for choosing the most suitable composition and process during development of the products from the trial stage to product scale-up stages. Guiding the teams for the conduction of bioequivalence or equivalent studies for registration purposes.
• Plan and schedule R&D activities and duties in accordance with “Pipeline Committee” decisions and set the target product delivery date for each project.
• Manage and plan the technology transfer activities including in-License, out license and site transfer products.
• Conduct periodic meetings with the team, cross functional teams, and other stakeholders, guiding them regarding work priorities.
• Approve documentation for products in support of product registration activities.
• Follow up to date guidelines, international and national regulations relevant to product development as per the requirements of regulatory authorities.
• Define R&D procedures and systems in written SOPs and ensure implementation.
• Enforce the implementation of the cGLP, GMP and adherence to SOPs of formulation and proper documentation of all experiments and observations.
• Participate in developing the departmental budget for Capital Expenditure, Operating Expenditure, and Headcount and manage spending within the set budget and ensuring compliance.
• Participation in the planning/marketing meetings for launching the new products by providing the required documents and technical support.
• Develop managerial and technical capabilities within the department towards the achievement of the set plans and objectives.
• Define job specifications & descriptions for formulation and process development employees.
• Training, teaching and supervision of formulation team members, including safety, health and industrial hygiene. 

Competencies:

• Transparency, Effective Communication, Ownership, Accountability, Collaboration & Team Unity, Employee Development & Training, Innovation and Creativity.
• Ability to influence, Team Engagement & Development, and Flexibility.
• Excellent organization skills and ability to work on several products and projects with tight timelines is required.
• Knowledge of team dynamics and ability to function as a leader with a proven track record of leadership and management skills of cross-functional teams and professional staff, as well as motivational skills.
• Innovative thinking, Ability to lead innovative and/or transformative projects and strives for continuous improvements.
• Conflict management and resolution skills - Build consensus, anticipate and solve problems.
• Results-focused – Ability to organize and manage multiple, and at times competing priorities.

Job Requirement:

• PhD / MSc in pharmaceutics, or Industrial Pharmacy.
• 15 to 20 years of relevant experience overseeing R & D projects with a deep understanding of the core principles of research and development on the adoption of new technology and equipment to improve the organisation's operations and business.
• Expertise in development of formulations with strong theoretical knowledge and experience.  
• Adequate experience in formulation development, process development, analytical method development and well versed with all regulatory requirements such as JFDA, SFDA, GCC, ICH, USFDA and EU.
• Understands the phases, processes and techniques used within a drug development environment. 
• Technical Knowledge of Clinical and Non-clinical studies, DMF, CTD and cGMP/GLP.
• General knowledge of Good Clinical Practice (GCP), Good Manufacturing Practices (cGMP) and applicable regulations, guidelines, and regulatory processes. 
• Knowledge of pharmaceutical manufacturing and equipment, utilities, and facility.
• Knowledge of patents, intellectual property rights, drug laws and regulations.
• Proficiency in both written and spoken English.