Location: Andheri, Mumbai.
(Hybrid working)
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose of improving patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network, complements our global operations.
ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role
The purpose of this role is to ensure a consistent and reliable supply of complex sterile biological and biosimilar products by supporting contract manufacturers with expert technical guidance. It involves troubleshooting manufacturing challenges, conducting detailed due diligence, and delivering key projects such as site transfers, material changes, and process improvements. The role also provides critical technical support to internal stakeholders, ensures compliance with licensing and manufacturing standards, and serves as a subject matter expert who can communicate complex concepts, anticipate risks, and influence strategic decisions.
What You’ll Do:
- Expert knowledge in the technical/manufacturing domain for sterile, biological / biosimilar products and beyond the specific area / across a wide range of the GxPs.
- Capable of presenting as a subject matter expert during health authority inspections / cross-functional discussions. Point of contact for cross-functional teams for the associated technical area.
- Author, review and approval of technical documentation independently e.g., technical justifications, RFI responses, technical summary reports for complex regulatory submissions.
- Provide technical solutions during troubleshooting and provide expertise for associated activities across business units for the lifecycle management of routinely manufactured products or new products
- Lead due diligence risk analysis / due diligence for new products/acquisitions and manufacturing changes, including an overview of process/packing validation-related activities
- Deliver specific projects that include site transfers, changes to material sources, reformulation, and process improvement with a high degree of complexity. Project management of assigned life cycle maintenance activities and ensure timely reporting of updates.
- Provide technical services to support internal stakeholders, and provide expert inputs to License and Manufacturing compliance.
- Ability to provide on-site support to contract manufacturers to improve the ongoing supply of difficult-to-make products.
- Take the lead in decision-making for progressing with batch manufacturing and release considerations, product write-offs in tandem with cross-functional stakeholders. Participate in cross-functional meetings for driving decisions.
- Anticipate internal and external business challenges and provide unique solutions to complex manufacturing/production problems that have a significant impact on the business.
- Use inferences from a set of data (e.g., from KPIs) to make changes/improvements in existing processes.
- Participate in a continuous improvement initiative outside of the technical area. Ability to train/mentor internal and external teams.
- Ability to generate and drive the cost-benefit analysis process independently. Manage budget, reforecasting of budgets, and improving existing processes within the team for budget management.
- Execution of other tasks as delegated by the Line Manager, which contribute to the overall running of the business unit.
- 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 the 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:
- Bachelor’s degree/ Master’s degree in pharmacy or biotechnology, or other technically relevant graduate-level qualification
- Prince 2 and MS Project
Knowledge, Skills & Experience:
- Must have significant experience in a technical role (Drug substance / Drug product development / Tech transfer / Production / LCM) within the pharmaceutical or biotechnology industry, preferably for regulated markets.
- Strong technical expertise in sterile pharmaceutical products, particularly biologics and biosimilars, across development and commercial manufacturing.
- Proven experience managing complex scientific and technical projects, with working knowledge of project management methodologies and tools.
- Skilled in authoring and reviewing regulatory documentation, including eCTD Module 3, Quality Overall Summaries, and expert statements.
- In-depth understanding of global regulatory requirements, GMP, process validation, and batch manufacturing/release for biologics.
- Open and adaptable to challenging environments.
- Competent with spreadsheets (Excel) and PowerPoint
- 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.
