347483BR
Jun 22, 2022
India

Job Description

1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Leading the team of experts for development of generic pharmaceutical products in compliance with Good Development Practice, Good Manufacturing Practice and Sandoz internal quality requirements at SDC India.
Key objective is development of stable, cost efficient and bioequivalent formulation with robust technological processes, by taking into consideration relevant patent landscape in order to achieve launches in countries of scope and regulatory agencies approvability in cooperation with cross-functional teams.
Typical work starts with a project evaluation from formulation development point of view and setup of formulation development strategy in alignment with patent landscape to enable earliest possible launch, followed by an execution of development work. This includes pre-formulation characterization including reverse engineering, formulation development with all QbD elements including the use of digital tools and modelling and simulation, setup of manufacturing strategy, scale up from laboratory to production scale and successful transfer to the commercial production site. Work packages also cover generation and storage of all relevant scientific and business related data and protection of own Intellectual property.

The Head of the Formulation development manages a group of associates and allocated resources to achieve the departmental objectives according to cross departmentally agreed project plans, quality, timelines and standards of SDC.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• Leads and manages the India SDC Formulation Development team with high focus on technical, scientific excellence and people development
• Sets ambitious goals for the team and clear vision and strategy for Formulation development, in line with SDC India vision and broader Sandoz Product Development and Sandoz strategy
• Creates psychologically safe working environment where speak up culture is the norm, provides and seeks regular feedback to and from associates, peers and other stakeholders
• Establishes structured and regular knowledge sharing within and across teams and in global forums
• Assesses competencies and establishes clear actions to address gaps and future needs, e.g. by upskilling in specific areas or by individual-specific development plans
• Proactive development of key competencies to comply with anticipated development trends and regulations and to ensure objectives are met or overachieved.
• Drives top-level talent acquisition, succession planning and development of all associates within the department with high focus on diversity and inclusion of talents, fairness and equal opportunities
• Actively coaches and partners with direct reports to build and implement their individual development plans.
• Systematically sets clear expectations and fosters mutual collaboration, transparency, integrated alignment and quality of interactions as a desired operating behavioural model
• Consistently applies adequate consequence management to incentivize and recognize positive contributions
• Sets, communicates and aligns meaningful aspirations in terms of competitiveness and key drivers, translating them in consistent and prioritized targets and plans for the organization (fillings, launches, etc).
• Ensures that department resources are optimally utilized(i.e. FTE, budget, capabilities) and in line with the business need to ensure cross-departmentally agreed timelines and key milestones are successfully met.
• Manages planning, implementation and evaluation of experiments for establishing of composition, manufacturing procedures and packaging via support of deformulation/formulation experiments, use of digital tools, modelling and simulation, taking product stability, bioequivalence and possible production site into consideration.
• Ensures that the screening of literature and patents is performed assessing the significance on the development activities, in collaboration with patent experts.
• Develops new and unique ideas and strives for innovative solutions.
• Implements and monitors quality related topics within the department (e.g. QbD), supports the local quality plan in close collaboration with Quality management.
• Reviews and approves quality-related documents (e.g. development reports, transfer documents, etc.); ensures data traceability from project start to launch.
• Supports dossier compilation through close collaboration with Regulatory affairs department.
• Promotes collaboration with key stakeholders during development of dosage forms, in particualar with Analytical Development, IVIVC, Clinical development, IPand Project Management
• Provides technical support during product registration phase through responding to deficiency letters and complaints in a timely manner.
• Provides support as required during internal and external audits and inspections.
• Ensures an optimized organization structure to support continuous improvement and efficiency and ensure alignment of operations with other departments and organizational entities
• Provides input and adherence to budget in order to meet financial goals of the SDC.
• Leads or support global groups or initiatives within the Sandoz Product Development (e.g. Global pharmaceutical development team, Sandoz Operational QbD team, etc.)
• Ensures compliance with cGmP and GDP, all relevant SOPs and reg. requirements

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE:

• Minimum Masters degree in natural sciences. Desirable: Advanced degree from the field of pharmaceutical or natural sciences (PhD or equivalent).
• Minimum 8 years relevant experience in pharmaceutical development and good knowledge of current analytical methods.
• Broad understanding of generic drug product development and sound understanding in the area of tasks and responsibility
• Detailed knowledge of product development (from project allocation to launch)
• Detailed knowledge of cGMPs, quality management, regulatory guidelines as well as relevant safety and environmental regulations
• Strong leadership and written/verbal communication skills
• Basic knowledge in finance and business planning
• Develops high quality solutions to complex technical challenges. Innovative and Creative: strives for innovative solutions

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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347483BR

Head Formulation Development

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