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Sr. Specialist Quality Biosimilars

2 weeks ago

Mumbai Metropolitan Region, India ADVANZ PHARMA Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Location: Andheri, Mumbai.

(Hybrid working)

About the Role

The Senior Specialist, Biosimilars will provide technical support to the Associate Director, Biosimilar Quality on all aspects of biological products and the development and enhancement of the Pharmaceutical Quality System to ensure it meets Health Authority expectations.

The portfolio will consist of a range of products including in-licensed and development projects.

This role will involve exposure to management across the business and requires an individual with a dynamic and collaborative approach.

What You'll Do:

  • The maintenance of the Pharmaceutical Quality System to ensure it remains "fit for purpose" with respect to Biologics/Biosimilar products.
  • To support the Associate Director, Biosimilars and the Strategic Quality team in the assessment of several new pipeline products in support of ADVANZ PHARMA's strategic initiatives and objectives.
  • Support the necessary Quality activities to ensure on time delivery and launch of all pipeline projects.
  • Proactively identify and highlight potential Quality risks, hurdles or issues which may impact project scope, and ensure practical resolution or escalation where necessary.
  • Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others). Address issues/requests by the Agency during MAA.
  • Support in the preparation for Quality Review Meetings with our partners, escalating risks/issues appropriately to remove barriers to success or advise of delays and other changes which may impact Quality and or supply.
  • Provide QA oversight of analytical method development, validation, qualification, and transfer activities for the biologic/biosimilar portfolio.
  • Review protocols and reports for analytical method validation, comparability studies, and bioassays (e.g., potency, identity, purity, and stability).
  • Evaluate and support resolution of laboratory investigations, OOS/OOT results, and method performance issues.
  • Collaborate with external testing partners to ensure analytical approaches meet regulatory and scientific expectations for biologics/biosimilars.
  • Act as subject matter expert in support of the Quality team in the review of Quality System records, incidents and changes.
  • Review analytical methods, procedures, protocols
  • Perform and oversee the lot disposition process
  • Perform change control assessments including document management
  • Review and approve/reject change controls
  • Approve Deviations and CAPAs and ensure all they are appropriately documented and investigated to determine and address root cause
  • Perform detailed risk assessments
  • Thrive in an entrepreneurial environment and take accountability for results.
  • Embrace challenge and change, applying a growth mindset approach.
  • Have a bias for action and fast decision making.
  • Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
  • Drive the spirit of "One Team" by working collaboratively across all business functions with an open, honest, and respectful cooperation.
  • Contribute to making ADVANZ PHARMA a desired place to work.

About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives.

For this role, you will also have the following:

Qualifications:

  • Tertiary qualification in any discipline within Life sciences or Pharmaceuticals
  • Additionally professional qualifications.

Knowledge, Skills & Experience:

  • Must be a subject matter expert in quality assurance of Biosimilars, with significant relevant experience.
  • Should possess strong experience in biopharmaceutical active substance production and analytics.
  • Experience working with Biologic and Biosimilar applications
  • Experience interacting with EU regulatory authorities – Scientific advice meetings
  • Broad knowledge and awareness of the European regulatory guidelines and legislation.
  • Have a good understanding of early development and validation programs for Biosimilars.
  • Excellent people management skills.
  • Sense of urgency/ willingness to operate within tight deadlines.
  • Ability to work with colleagues across a broad range of disciplines and functions.
  • Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others.
  • A positive and 'can-do' approach, biased towards finding solutions and embracing change.
  • Inspired by our values of entrepreneurship, speed, and integrity.
  • Learning agility and 'scalability', with a desire to continuously improve and develop as ADVANZ grows.
  • Work collaboratively across all business functions with an open, honest, and respectful cooperation.
  • Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities, and make things happen.

But there's more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now *

*Please include a CV and Cover letter.