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Lina Mody-Dave

New Product Launch Manager, Generics: Oral solids, Semi Solids , TDS and Injectables

Professional Background

Lina Mody-Dave is an accomplished New Product Launch Manager with extensive expertise spanning across the generics, pharmaceutical, consumer products, and medical device sectors. With a robust background in the intricacies of medical device launches and a thorough understanding of Quality ISO 13485 regulations, Lina has positioned herself as a key player in the highly technical realm of product innovation and pharmaceutical development. Her professional journey showcases an impressive trajectory that underlines her capabilities in Clinical Operations, Chemistry, Manufacturing and Controls (CMC) sections for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). Additionally, she has a strong foundation in drug development, formulation development, and analytical method development.

Lina has a demonstrated history of quality assurance review, focusing on manufacturing batch records and quality control data, and has effectively compiled Drug Master Files (DMF) to facilitate the commercialization of groundbreaking medical products. Her experience extends to supply chain and life-cycle management, ensuring that she brings a multi-faceted approach to every product launch she manages. Furthermore, her leadership in process improvements and cost reduction initiatives has led to successful quality audits and the implementation of various quality standard projects, reflecting her commitment to excellence and efficiency in operations.

Lina’s ability to navigate complex cross-functional global multi-cultural teams sets her apart as a highly effective leader. She adeptly leads teams with diverse working styles, influencing both horizontal and vertical team members to achieve common goals. Her excellent communication and interpersonal skills enable her to foster collaborative environments that yield innovative solutions and drive successful product launches. As a true visionary in her field, Lina possesses a strategic mindset complemented by her tenacity, ensuring she always remains at the forefront of pharmaceutical advancement.

Education and Achievements

Lina's academic background is equally impressive, holding a Master of Business Administration from Fairleigh Dickinson University and a Bachelor of Arts from Rutgers University. This combination of business acumen and a liberal arts education equips her with a unique perspective on managing products in the competitive pharmaceutical landscape.

Throughout her career, Lina has held significant roles in some of the most renowned companies in the pharmaceutical industry. Her prolific tenure includes serving as a New Product Launch Manager at Alvogen, where she has led various initiatives that integrate quality with innovation. Prior to this role, she was the New Product Launch Manager for generics at Corepharma LLC, contributing her comprehensive knowledge of drug development processes to deliver high-quality products on time.

In her previous positions, Lina showcased her project management skills as both a Project Manager and Consultant at Johnson & Johnson. There, she handled several high-stakes projects while ensuring compliance with stringent regulatory requirements. The experience she gained as a Senior Project Manager in Strategy and Technical Operations at Pfizer was invaluable, guiding her to excel further in product development strategies. In addition to these roles, Lina has also made significant contributions as a Project Manager in Consumer Products at Pfizer, and as a Pharmaceutical Product Development and Launch Project Manager at Catalent Pharma Solutions. Her career in research and development began at Novartis, where she served as a Senior Scientist and Scientist, further diversifying her expertise, particularly in quality control at Bristol-Myers Squibb.

Achievements

Lina Mody-Dave's extensive work in product launches and her ability to thrive within corporate environments exemplify her dedication to fostering innovation in the pharmaceutical industry. Her skills in leading quality audits and implementing comprehensive quality standard projects highlight her role as a pivotal figure in achieving greater accountability and transparency in product development.

As a strategic thinker with a solution-oriented mindset, Lina has a knack for identifying opportunities for continuous improvement. Her strong negotiation skills and her ability to influence team dynamics ensure that projects run smoothly and efficiently, with a focus on delivering results that align with the company’s vision. This multi-faceted approach has not only enhanced individual team performances but has also contributed positively to the organization's overall growth and success.

Lina’s expertise in cross-cultural collaboration enhances her effectiveness as a project leader in global settings. Her capacity to connect with team members from varied backgrounds fosters an environment that encourages creativity, responsiveness, and adaptability—qualities essential for thriving in today's fast-paced pharmaceutical landscape. By nurturing relationships across teams and departments, she has consistently delivered innovative products that are not only market-ready but are also aligned with consumer needs and regulatory compliance.

With a career marked by influential roles and significant achievements, Lina Mody-Dave continues to contribute to the advancement of healthcare and medical solutions. Her ongoing commitment to excellence, strategic planning, and innovative product development promises to shape the future of the pharmaceutical industry, making her a valuable asset to any organization fortunate enough to work with her.

Related Questions

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Location

Greater New York City Area