Mô tả công việc
Job Purpose
The formulation lead is responsible for
- Independently conducting formulation development activities of new products or optimizing commercial products
- Lead development work with external partners
- Supervising, guiding and following up junior scientists & technicians to achieve their respective goals.
Key Responsibilities
- Build strategy to develop new products by understanding critical technical requirements
- Work independently and recognize key issues likely to affect successful and/or timely completion.
- Design and execute formulation trials, interpret experimental studies intended to provide supporting data or to resolve technical issues encountered during each project.
- Identify technical issues and drive the completion of investigations that affect the technical scope, as well as recommend options to resolve the issue.
- Write/review master batch records, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, etc.
- Fully document all development activities
- Perform process transfer & support scale up to industrial batches
- Prepare the registration files
- Provide technical assistance/support for other departments in case needed.
- Stay updated on industry trends, regulatory changes and best practices. Drive the innovation output.
- Supervise, guide and follow up scientists & technicians to achieve their respective goals.
- Plan & follow up the schedule and budget
- Engage with diverse stakeholders across functions to understand the project scope, build the development strategy, present data and findings at internal technical /governance meetings, or present ideas and suggestions for new products
- Develop a network of vendors, CMO/CDMO
- Ensure Quality standards and procedures are implemented and respected by the team.
About You
Education
- BSc, Master or PhD in Pharmaceutical Sciences, Chemistry or a related field.
Related experience
- 5-year experience in developing formulation and process
- Experience in dealing with CDMO/CMO and presenting on technical topics related to scientific experiments.
- Experience supporting business development activities.
- Experience in supervising and mentoring other Scientists.
Core Competencies
- Leadership and mentoring skills.
- Strong organizational, analytical and time management skills.
- Excellent trouble‑shooting and problem‑solving skills, analytical thinking and attention to detail.
- Ability to work autonomously with a curious mindset, proactive drive and self‑motivation to achieve results.
- Proven ability to organize, plan and priorities tasks within a high volume, varied workload.
- Proven ability to adopt a methodical approach, managing multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out.
- Strong interpersonal and collaboration skills, team‑oriented and excellent work ethic with the ability to achieve successful outcomes.
- Experience in working in a multi‑disciplinary team environment.
- Experience with Statistics and Design of Experiments in applied research and development.
- Ability to critically evaluate results and to defend strategic guidance to resolve technical issues.
- Self‑starter with a passion to achieve results with proven ability to generate high quality on‑time results.
- Knowledge of regulatory requirements (pharmaceuticals, cosmetics, nutraceuticals) desirable.
- Excellent written and verbal communication skills in English.
- Proficiency in the use of Microsoft Office applications (Excel, Outlook, Word, PowerPoint).