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Koru Lifescience Limited is Hiring for their operations in New Zealand and China

About Koru Lifescience Limited
Koru can be best described as a Pharmaceutical R&D in the Age of agile, a fast-growing pharmaceutical research and development company bringing together an expansive pool of high-value experts under one umbrella and offering complex technologically advanced platforms in New Zealand.
Koru's business model fundamentally depends on product innovation to create value by delivering greater customer benefits. Further, sustainable growth and values creation depend on steady R&D productivity with a positive ROI in order to drive future revenues that can be reinvested back into R&D
Koru has a strong focus on "agility" to speed the development of products that better meet customer needs. The attractiveness of agility stems from its potential to increase time spent on value-added work and ensure decisions take days, not months, to enable faster reallocation of resources and to enhance engagement-all of which ultimately translates into dramatically reduced time to market.
This combination of specialist expertise and worldwide presence, underpinned by an unwavering commitment to quality and first-to-market advantage, powers our mission of always delivering affordable treatments to customers as quickly and as efficiently as possible.

You can find out more on our website www.korulifescience.com

About the role

You will work as a Senior Director Formulation  with a team of highly skilled senior scientists and participate in formulating innovative Pharmaceutical medicines ( human use ).

As a formulation expert you are required to exhibit the following skill sets:

  • Excellent ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
  • Excellent communication skills in multicultural, multi-lingual environments
  • Highly organized and structured
  • Excellent ability to lead large strategic programs
  • Excellent ability to exercise a high degree of independence to ensure program delivery and explore new areas of activities
R&D technical skills
  • Knowledge of Drug Discovery/Development
  • Knowledge of Clinical Research/Development
  • Strong knowledge of Regulatory (GCP, GLP, and GMP)
  • Strong knowledge of USFDA, EMA regulatory requirements (NDA, 505B(2), Hybrid, FTF, Para IV)
  • Strong technical writing skills (procedures, protocols, and reports)
Skills and experience

Job Description
  • Minimum 15 years of relevant industrial experience in formulation development research for Oral Solid Dosage forms using QbD principles for US and EU markets.
  • Sound understanding of DOE, QbD elements, ICH requirements, BA/BE requirements, CMC requirements, current Good Manufacturing Practices (cGMP) for US/EU submission.
  • Well versed with various manufacturing techniques like wet granulation/ dry granulation/ Fluid bed (Wurster) processing/ pelletization/ compression/ encapsulation.
  • Independently plans and executes unit operations involved in the manufacturing of Tablets/ Capsules/ PFOS/ Pellets/ Oral liquids and process optimization studies and Pre-formulation studies.
  • Preparation of various protocols/documents like Pre-formulation study protocols, Stability study protocols, Process validation protocols, Master Formula Card and Technology transfer documents.
  • Understands project timelines and deliverable and plans/coordinates project work accordingly with departmental, functional and external stakeholders.
  • Interprets analytical data of various formulation experiments and proactively identifies process or study issues/challenges and proposes potential resolutions/troubleshoot as and when required.
  • Practical experience of technology transfer of developed formulations from Lab scale to Production scale through effective communications with internal & external customers to ensure the success of scale-up activities
If you think you meet the above requirements and are looking to excel and grow in a successful, fast-growing, and international industry, apply today!

PLEASE NOTE THIS VACANCY IS FOR NZ AND CHINA

To know more, visit us online at www.korulifescience.com

Akhil Jain
akhil@korulifescience.com

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