Vice President - MSTG Orals

This role will focus on ensuring new products introduced from R&D are designed for manufacturability and the correct internal processes are in place for a seamless hand-off between the R&D and manufacturing plants around the globe. The role will lead all product transfer activities between global manufacturing sites, as well as scale up of products from R&D1 ( Baroda) to manufacturing. The team size is @70.

The successful candidate will own the monitoring of product and process parameters and will drive Product Robustness, including deploying the tools and ensuring organizational capabilities are in place to meet the growth needs of the business

VP of MSTG Orals will deploy appropriately skilled technical resources to lead hard–to-solve technical investigations and achieve speedy resolution of issues in manufacturing; will also ensure the appropriate technical depth around key technologies. He will serve as the Stage Gate approver for products going into Engineering batches as well as Submission batches, per the defined development business process.

An individual with a collaborative, inclusive and influential communication and leadership style with a strong global mindset is desired. The scope and breadth of technology includes: various oral solid dosage form, liquids,

There is a need to create a strong alignment with the regions to ensure technical competencies are leveraged and continue alignment with R&D and across key functions

ESSENTIAL AREAS OF RESPONSIBILITY:

Actively engage with R&D and act as the Stage Gate for products at the Engineering Batch and Submission stage of new product introductions.

Create, promote and improve business and technical processes. Drive global standards for validation and product robustness across all the regions.

Develop and implement a knowledge data base system to ensure that technical transfer activities are executed and summarized with appropriate results in approved reports to support regulatory filings and tech transfers.

Should have knowledge of Product development expertise using QbD principles and expertise in evaluating the relationships between CPP and CQAs.

Expertise and skills to oversee Structured Root cause investigations and commercial trouble shooting including ensuring a right process is followed and CAPA identified.

Establish process monitoring and improvements at commercial manufacturing facilities and at Contract Manufacturing Organizations (CMOs) using scientific/technical concepts and techniques in collaboration with Site Technical leaders.

Review and approve proposals for improved manufacturing processes, implementation of PAT and other tools that enhance process robustness and state of process and product knowledge.

Skills in product scale changes and suggesting manufacturing modifications if required with a full 360 deg impact assessment to ensure faster and smoother implementation

Deliver agreed financial targets such as departmental budget and key performance indicators

To coordinate with different departments i.e. Formulation Development, Production, Project Management, Quality Control, Quality Assurance, Packaging for the timely execution of the New projects (Exhibit batches) for solid dosage plants in India.

To oversee manufacturing of trial /scale up & exhibit batches, pre –launch/Characterisation batches & process validation batches for US, Europe, Canada, emerging and India market

To arrange for the readiness of the New Product Launch at solid dosage plants in India

To review & respond for process related regulatory query for exhibit batches.

To review Justification/Investigation/Technical report for any event/incidence observed during the execution of the Exhibit batches.

To investigate and support operation to resolve the Trouble shooting projects for solid dosage plants in India. To review Life cycle management projects like batch size increase, solvent reduction etc and provide technical support to Operation for implementation of same.

To review site transfer documents and identify Gaps and support technical part to operation.

To support operation and quality for alternate vendor qualification as per Global & site SOP.

Identify and improve product robustness in collaboration with QA and production.

To conduct weekly, Monthly and quarterly review meeting with all MSTG leads and key team members of all solid manufacturing plants in India. To conduct Monthly team huddle meeting with entire MSTG team of solid oral

To participate in various regulatory audits to support plant.

To contribute in Team building by imparting Training to teammates to upgrade capability

Identification and evaluation of new technologies that can make SPIL competitive in manufacturing.

MINIMUM QUALIFICATIONS:

Advanced degree in pharmaceutics or science or engineering with minimum 15 years’ experience in the pharmaceutical drug product industry is preferred; Ph.D. or other advanced degree with comparable industry experience is desired.

Demonstrated communication skills, both verbal and written; ability to influence others and build cross-functional teams while setting clear business objectives

Demonstrated leadership and technical experience as well as a proven track record of transferring technology and products from R&D to manufacturing.

In-depth understanding of CMC regulatory requirements and technical risk management.

Ability to present complex scientific information to all business audiences

Sustained excellence in performance and accomplishments that align to company goals.

Demonstrated competency in development of plans (milestones, timelines, resources, etc.) for analytical and manufacturing transfers.