always on target
SUMMARY OF POSITION
The Senior R&D Director will be responsible for overseeing the formulation & analytical developments and monitoring all the related R&D activities of the assigned projects. Further the position will be responsible for providing scientific leadership and operational oversight of the assigned R&D projects. The Senior R&D Director will work collaboratively with cross-functional teams to drive the development of assigned new products and ensure their successful development from pre-formulation development through regulatory approval.
ORGANIZATION STRUCTURE
This role will report directly to the SVP, R&D and Clinical.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
- Manage the assigned R&D team members in the execution of the development programs for generics and 505(B2).
- Provide scientific and technical expertise in the development of new products for EU, US, BR, CA, and other highly regulated markets.
- Develop and implement R&D strategies to advance the company's pipeline and achieve key business objectives.
- Responsible for technical contribution to the development strategy, planning and implementation of all the assigned development programs.
- Ensure the timely delivery of high-quality, scientifically sound, and innovative drug candidates for development.
- Manage and develop a high-performing R&D team, providing mentoring, guidance, and coaching to promote career growth and development.
- Manage R&D budgets, resource allocation, and timelines, ensuring effective alignment with corporate goals.
- Work closely together with internal and external cross-functional teams, e.g., PMO, CMC, RA, Intellectual Property, Production, Quality, Portfolio Management, Strategic Partnership and Business Development.
- Strictly follow all the relevant established international pharmaceutical quality and regulatory standards.
- Provide scientific and technical expertise in the development of solid oral dosage form, topicals, injectables and inhalers for EU and US market.
- Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs.
QUALIFICATIONS & REQUIREMENTS
- MS in pharmaceutical science, chemical engineering, or equivalent scientific discipline. PhD is an asset.
- At least 20 years of experience in pharmaceutical technical development disciplines, with a track record of successful leading of development programs till approvals in highly regulated markets.
- At least 10 years of leadership experience leading a development team.
- Strong leadership skills, with experience managing and developing high-performing R&D teams.
- Able to multi-task in a dynamic environment.
- Strong ability to make data-driven decisions and manage complex R&D projects and timelines.
- Organized and able to lead a functional group of R&D.
- Excellent interpersonal and communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and build relationships with key stakeholders.
- Working understanding of GMP and QSR regulations and guidance applicable to the development of products.
- Experience with EMA, FDA, ANVISA, HC and other regulated markets with an understanding of regulatory requirements.
- Proven track record of successful product developments.
- Experience and knowledge across a broad range of different technologies for peptide developments.
- Proven ability to manage multiple projects at a highly scientific operational level.
Why join us?
Exciting Challenges:
Supportive Environment:
Career Development:
Recognizing Excellence:
Fun and Inclusive Culture:
Ready to Ignite Your Passion?
If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!
Please be informed that only selected candidates will be contacted.
