At Adalvo, we're not just a company
- we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo ? ? We are looking for an enthusiastic Director, R&D; to join our dynamic Strategic Scientific Affairs team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you. SUMMARY OF POSITION The R&D; Director will be responsible for the pharmaceutical development and tech transfer of new products, with a strong focus on the high-potent drugs in target finished dosage forms. Will perform duties in accordance with company policies and procedures. The R&D; Director will work collaboratively within the R&D; team, and other internal and external cross-functional teams to successfully drive the operational execution of R&D; and TT products till approvals. ORGANIZATION STRUCTURE This role will report directly to the VP, R&D; Global. RESPONSIBILITIES Primary responsibilities of this role include the following:
- Hands on execution of the development programs and tech transfer of the new products
- with a strong focus on the high-potent drugs, e.g., oncologic drugs, in target finished dosage forms.
- Together with the respective R&D; team plan and elaborate on scientifically sound experimental development activities, and lead their execution, data interpretations and technical conclusions.
- Establish a strong relationship with key internal and external partners by regular technical meetings (remotely and face to face).
- Provide specification for API,
Raw and packaging materials to support supply chain in the identification of suitable supplier.
- Facilitate the resolution of technical issues in a timely manner, driving action items and follow up.
- Manage and support DP validation activities.
- Create intellectual property covering pharmaceuticals products.
- Support internal and external functions to ensure a smooth transfer of technologies and products into additional commercial manufacturing site (if required).
- Ensure accurate tracking and reporting of project deliverables and milestones, maintaining consistent project documentation and preparing periodic updates for the Senior Management.
- Actively assist other department team members in reviewing documents on other projects (protocols, reports, regulatory filings, specifications, and the like).
- Establish effective working relationships within other key with internal and external cross-functional teams, e.g., PMO, RA, Intellectual Property, Production and Quality Assurance & Control. QUALIFICATIONS & REQUIREMENTS
- BS/MS in Pharmacy or Pharmaceutical Technology with 8 years of industrial Drug Product development experience for highly regulated markets. PhD is an asset.
- Hands on experience and expertise in the pharmaceutical development of oral dosage forms and topicals.
At least 3 years of experience on development with high-potent drugs is highly desirable.
- Experience with EMA, FDA, ANVISA and other regulated markets with understanding of regulatory requirements.
- Experience in management of high-performing R&D; team.
- Able to demonstrate strong attention to detail while working under pressure.
- Ability to communicate and connect with all levels of the organization.
- Solid leadership and resource management skills.
- Excellent English written/oral communication skills are required. CORE COMPETENCIES
• Business Focus
• Strategic Thinking
• Results & Operational Excellence
• Collaboration
• Quality
• Innovation & Continuous Improvement
• Change Agility Why join us? ? Exciting Challenges: Every day brings new opportunities to learn and grow. ? Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard. ?Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities. ?Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements. ?Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team. 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
📌 Director of Research Development (Mumbai)
🏢 Adalvo
📍 Mumbai