Head - Product Delivery - Pharma

Responsibilities:

- Leading a group of formulation scientists for development of a product portfolio (generics or differentiated generics) in collaboration with other I&D functions and the Director, Formulation Development, India.

- Support / Collaborate innovation for discipline and across functions to creates new ideas and develops ideas to product prototyping.

- Analyze and anticipate trends in areas of research and futuristic technologies across dosage forms; Develop long-term futuristic product strategies that meet business objectives, through identification of all road blocks and definition of mitigation plans

- Represents the Formulation Development Team function and informs senior management of plans, risks and progress through regular communications.

- Planning of work for the team; Technical guidance and support to group members

- Coordinating with internal customers for the following

- Documentation related to formulation activities

- Planning and procurement of consumables and equipment

- Proposing annual budget for the group / department

- Coordination with external customers i.e., QA, SCM, BD and medical

- Guide the team members in developing the product based on principles of QbD

- Guide team members and review CMC documents for regulatory submission (e.g., DCGI)

- Guide team members and review preparation of Pharmaceutical Development report (PDR) for Quality module of CTD.

Supervisory/Management Responsibilities:

- Manages and guides a team of formulation development scientists with all assigned areas of responsibility

- Establishes and maintains an environment that assures the retention and recruitment of scientific talent

- Mentors and guides junior team members and technical trainees

Functional/ Technical

Formulation and Product Development

- Analyze and anticipate trends in areas of research and futuristic technologies across dosage forms

- Develop long-term futuristic product strategies that meet business objectives, through identification of all road blocks and definition of mitigation plans

- Holistically reviews success of the product from all perspectives (RA, IP, Analytical) and provides inputs

- Review and align formulation development strategies to business goals across dosage forms

- Design most relevant pre-formulation studies and new /accelerated methods relevant to respective dosage form and product based on practical knowledge and expertise in drug-excipient interactions for various dosage forms

- Partner with business for market insights to drive product differentiation using technology/drug delivery platforms

- Influence top management on new technology platforms and investments required

Quality by Design:

- Coordinate and facilitate QbD meetings for new products (e.g., QTPP, CQA, Risk Assessments, and Risk mitigation).

- Participate in QbD Process Improvements

- Understands the principles of DOE and ensures that it is implemented in team in the products wherever needed for formula and process optimization

- Ensure implementation of Right First Time approach in experimental work, process improvements, and document review.

Scale-up and Technology Transfer:

- Understands and applies scientific principles for scaling-up the process from R&D to commercial manufacturing sites

- Ensures development of robust process that can be successfully tech transferred for scale-up and commercial launch

Pharmaceutical Development Report (PDR)

- Reviews and approves the PDR developed by his team

- Provide answers for any queries from regulatory on PDR

Project Management

Tracks Projects on ongoing basis to ensure completion to agreed timelines for the different phases - prototype development, Stability initiation, Dossier Submission, Technology Transfer, Scale-up and Commercial manufacturing

Regulatory

Devise and set-up systems for effective prevention as well as response to regulatory deficiencies based on extensive experience in area of specialization

Education & experience:

- M. Pharm with 18+ years of experience / Ph. D. With 14+ years of experience

- Experience in various pharmaceutical technologies & drug delivery systems innovation

- Good verbal & written communication skills with ability to manage global stakeholders

- Rich experience in technology platforms and demonstrated success in new product development and launch support.

- Demonstrates competence and potential for leading the Product Delivery division with strong leadership and strategic skills