Global Head Research And Development

Global Head - R&D

Location:

Industry:

Experience:

Qualification:

CTC – not a constrain for the right candidate

Age - max 51 yrs

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Summary of Position:

The Global Head R&D will lead and grow a 60+ team of formulation scientists, analytical scientists and other technical professionals with responsibility for developing products (mainly oral solid dosage forms). This includes leading the identification of a strong pipeline of projects to support consistent flow of ANDA and NDA filings. These scientists are in Hyderabad India.

This position will have responsibility for creating a culture and atmosphere aligned with the company values, building key technical and leadership capabilities within the teams and maintaining a productive, diverse, and engaged workforce, comprised of the best talent.

Responsibilities:

product formulation, method development, method validation, stability testing, R&D tech transfer, Authorities deficiency response and technical filings.

•Ensure constant flow of ANDA and NDA filings for new project launches, through oversight of project timelines and budgets.

•Prior experience of managing successful approval process for US &European Markets

•Overall team leadership includes setting individual/team goal, ensuring employee development, providing on-going coaching and feedback, recognizing employees for their contributions and creating an inclusive and safe work environment.

•Ensure (internal and external) audits and review procedures, processes, data and laboratory preparedness for inspections.

•Ensure all work is completed within cGMP, SOP, FDA, ICH guidelines, including ensuring staff is fully trained in all requirements.

•Provide technical direction and guidance to the team in response to deficiency letters and ensure timely deliverables.

•Prepare and manage budgets for staffing resources, laboratory supplies and capital expenditures

•Participate as a member (key driver) of cross-functional teams including partnership with Regulatory, R&D, Manufacturing, Procurement, etc., to ensure achievements of company goals.

•Identify new technology for implementation to ensure R&D remains current with the industry.

Qualifications:

•Phd must

•20+ years of experience in the area of generic drug development & oncology product development.

•Thorough knowledge of oral dosage forms is required, including understanding of production, clinical studies and regulatory requirements.

•5+ years supervisory experience of multi-disciplinary R&D organization, including leadership of people managers.

•Strong people leadership skills include setting individual and team goals, providing feedback, recognizing strong performance, providing coaching and facilitating career development.

•Strong interpersonal skills to influence and guide internal and external stakeholders effectively.

•Ability to partner cross-functionally and work on cross-functional teams (QA/QC, Regulatory, Manufacturing, Procurement, etc.).

•Proven ability to manage progress and delivery of consistent flow of ANDA and NDA filings.

sam@tpchr.in