Technical Specialist

Location: Andheri, Mumbai

(Hybrid working opportunity)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve 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 complement 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

As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Technical Specialist.

What You’ll Do:

• Expert knowledge in technical/manufacturing domain and beyond the specific area / across a wide range of the GxPs.
• Capable of presenting as complex topics as subject matter expert during health authority inspections / cross-functional discussions.
• Point of contact for cross-functional teams for associated technical area for internal and external stakeholders.
• Author, review and approval of technical documentation independently e.g. technical justifications, RFI responses, technical summary reports for complex regulatory submissions.
• Generate risk analysis reports / due diligence and equivalency reports for manufacturing aspects including overview of process / packing validation related activities.
• Provide technical solutions during trouble shooting and provide expertise for associated activities across business units for lifecycle management of routinely manufactured product or new products.
• Deliver specific projects that include site transfers, changes to API sources, reformulation and process improvement with 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, provide expert inputs to License and Manufacturing compliance.
• Ability to provide onsite support to contract manufacturers to improve on-going supply of difficult to make products.
• Take 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.
• Interpret 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 set of data (e.g. from KPIs) to make changes / improvements in existing processes.
• Participate in continuous improvement initiative outside of technical area. Ability to train / mentor internal and external teams.
• Ability to generate and drive cost benefit analysis process independently. Manage project budget, reforecasting of budgets, improving of existing processes within the team.
• Execution of other tasks as delegated by Line Manager which contribute to overall running of the business unit.
• 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: 

• Master’s degree in pharmacy; or other technically relevant graduate level qualification.

Knowledge, Skills & Experience:

• Must have significant experience in a technical role (Production/QA/Formulation development, regulatory CMC) within the pharmaceutical or medical devices industry preferably for regulated markets.
• Excellent technical knowledge of all solid, semi-solid & liquid pharmaceutical dosage forms including sterile products.
• Should have managed several technical &/or scientific projects of varying complexity and scope. Having working knowledge of project management methodology (e.g. Prince 2) and preferably has practical experience with project management tools e.g. MS Project
• In depth working knowledge of project management methodology (e.g. Prince 2) and practical experience with project management tools e.g. MS Project).
• Fully conversant with the regulatory guidelines/ requirements and has authored significant documents that have been directly included in a submission without rewording or reworking.
• Should be able to perform risk assessments for manufacturing issues and conduct trouble shooting activities in collaboration with internal / external stakeholders and CMOs.
• Excellent knowledge of established global guidelines and ICH guidelines affecting product design, routine manufacturing operations and product quality.
• Working knowledge of API manufacturing processes, issues and requirements.
• Ability to work under pressure and to tight time deadlines.
• Excellent grasp and use of grammatically correct written and spoken English with global mindset.
• Excellent logic, analytical, reasoning and problem-solving skills
• Proactive nature with focus on proactive prevention of possible issues.
• Persists with challenging situations - does not give up in spite of barriers and obstacles.
• 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.