Director Of Research Development

Adalvo; Mumbai; Presencial; INR 4 000 000 - 9 000 000; Tempo integral

Resumo da oferta

Adalvo is seeking an enthusiastic Director, R&D to lead pharmaceutical development and tech transfer for high-potent drugs. The role collaborates with the R&D team and cross-functional partners to drive projects toward approvals, ensuring regulatory compliance and robust technical execution.

You will work under the VP, R&D Global, oversee DP validation, IP creation, and smooth transfer of technologies to manufacturing sites as needed. Strong leadership and communication are essential.

Qualificações

• 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 in development of high-potent drugs and regulatory compliance.
• Experience with EMA, FDA, ANVISA and other regulated markets.

Responsabilidades

• Lead development programs and tech transfer of new products with focus on high-potent drugs.
• Plan and elaborate scientifically sound development activities and lead execution and analysis.
• Maintain strong relationships with internal/external partners through regular technical meetings.
• Provide material specifications for API, raw and packaging to support supply chain.
• Facilitate resolution of technical issues and drive action items.
• Support DP validation activities and contribute to IP creation.
• Ensure smooth transfer of technologies to additional manufacturing sites when required.
• Track project deliverables, maintain documentation, and report progress to senior management.
• Review documents across projects and coordinate with PMO, RA, IP, Production, QA/QC.

Conhecimentos

Leadership

Regulatory knowledge

English communication

Project management

High-potent drug development

Formação académica

BS/MS in Pharmacy or Pharmaceutical Technology

Descrição da oferta de emprego

Job Description

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

• 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.
• Strong 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.