Assistant Manager - Analytical Development (Home Based Role in India)

 Posted 2 months ago
  
 India
  
5-10 years experience
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AI Summary

The Assistant Manager will oversee and manage analytical activities across various development projects, which includes critically evaluating analytical data and ensuring compliance with quality and regulatory standards. Key duties involve reviewing reports, overseeing external partner activities, managing method transfer, and supporting regulatory inquiries.

Competitive Salary & Company Benefits| Home Based Role in India

Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?

Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

Do you want to be part of the journey?

If so, here is your chance!

The Role

We are seeking a highly skilled and detail-oriented Analytical Development Assistant Manager to oversee and manage analytical activities across multiple development projects. This role involves critical evaluation of analytical data, collaboration with external partners, and ensuring compliance with regulatory and quality standards.

What will you be doing?

  • Review analytical data, interpret results, and provide recommendations

  • Oversee analytical activities and documentation at external partners (CDMO/CMO/CTL)

  • Conduct literature reviews and assess DMFs for new projects

  • Collaborate with CROs on method development strategies

  • Review and approve:

    • Method development & validation reports

    • Analytical procedures and specifications (STPs)

  • Manage Analytical Method Transfer (AMT) including protocols, data review, and reports

  • Monitor timelines for development, validation, and transfer activities

  • Review QC activities, including OOS/OOT investigations

  • Support regulatory queries and participate in audits

  • Ensure compliance with cGMP, ISO 9001:2015, and regulatory standards

The Person

  • 7+ years in Analytical Development or related field

  • Strong experience in method development, validation, and data review

  • Excellent communication and stakeholder management skills

  • Ability to critically assess data and drive decisions

Why join us?

  • As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:

  • Life Assurance cover and Employee Assistant Program.

  • Learning and Development opportunities.

  • Excellent opportunities for progression.

  • Company events and celebrations throughout the year.

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