Associate Director, Drug Product Development
|Contact Name:||Laurentina Kennedy|
Our client is seeking an Associate Director to join the Technical Operations team.
Reporting into Sr. Director, Product Development, the Associate Director, Drug Product Development will provide scientific and technical leadership for drug product development projects at various stages of the development life-cycle including pre-formulation, formulation and process development, transfer and validation. The range of technologies used will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery systems, including controlled-release dosage forms and drug –device combination products for different routes of administration.
The Associate Director, Drug Product Development is responsible for leading projects from the technical feasibility evaluation through commercial registration. Success requires application of scientific and/or engineering principles and creativity to formulation design and development studies, and translation into commercially feasible, reliable and robust formulation and processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs). The position has high accountability in both financial and technical decision-making (program direction and development paths).
Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports, supporting CMC aspects of regulatory dossiers, and participation in department or functional initiatives.
The Associate Director, Drug Product Development will involve significant cross functional collaboration with other functions including R&D, New Product & Technology Integration, Regulatory Affairs,
Manufacturing and Quality, working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control. The role is both project and operations orientated. It will require an ability to drive and deliver multiple projects concurrently.
Wide-ranging experience in pharmaceutical development and manufacturing of drug product with a strong background in formulation and drug delivery technologies focused on small molecules.
Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support formulation and process development objectives.
Experience of CMC regulatory requirements for pharmaceutical products and in particular application of QbD principles.
Create intellectual property covering products and ensure freedom to operate in the development of new drug products.
Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
Support other Product/Process Development and Manufacturing areas to ensure a smooth transfer of technologies and products to contract sites.
Technical program management and oversight, including workflow, progress and milestones delivery by external contract manufacturing organisations (CMOs).
Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings.
Assist other department team members in reviewing documents / data in support of product development (e.g. clinical protocols, PK study results).
Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
Ensuring all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
Planning, executing and reporting for all development projects and technology transfers in support of process improvement and new product introductions.
Developing knowledge of new pharmaceutical manufacturing processes as required in line with business objectives.
Working closely with all leaders to monitor, and where necessary, implement improvement initiatives in line with continuous improvement philosophy.
Required Knowledge, Skills, and Abilities
Strong record of achievement in formulation and process development, technology transfer, process scale-up and commercial drug product manufacture.
Over ten years of experience required with a broad experience across drug development and manufacturing technologies but with specific experience related to drug product development.
Demonstrated technical expertise in pharmaceutical development and new product introduction for small molecules.
Experience in defending, process, procedures and investigation during Regulatory Agency inspections desirable.
Capable of grasping complex technical issues and making sound decisions based on data and information from various sources.
Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
Knowledge and experience of working with statistical process control techniques in an operational excellence environment is desired.
Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought.
Strong teamwork skills.
Experience in intellectual property development desirable.
Excellent written and verbal communication skills with ability to multi-task.
Proven project management skills for technical programs.
Direct experience with CMC regulatory filings for pharmaceutical products.
Flexibility to travel on company business when required (up to 25% travel).
Required/Preferred Education and Licenses
Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work-related experience required.
For further information on this AD Drug Product Development position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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