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 more than 700 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 Associate Director for Biosimilars Technical Services will ensure timely technical expertise for development, manufacturing, and packaging operations is provided to the business to mitigate any quality, regulatory compliance or supply-related issues and support the product launch and life cycle.
What You’ll Do:
- Provide technical expertise to the business for all biologics and biosimilar products.
- Ensure manufacturing (technical) or packaging and artwork issues impacting continuity of supply, product quality, or compliance get timely resolved.
- Apply critical thinking for key decisions; anticipate risks and implement mitigation plans.
- Take the lead in decision-making for manufacturing and release considerations, product write-offs in tandem with cross-functional stakeholders.
- Maximize efficiency and productivity through extensive process analysis and interdepartmental collaboration.
- Ensure that critical activities are prioritized in accordance with the product supply status and that the timelines provided are adhered to.
- Analyze current operational processes and performance, recommending improvement solutions when necessary.
- Proactively identify and solve complex problems that impact management and direction of business.
- Ensure that functional support is provided for any product or company acquisitions, thus ensuring a timely integration in line with business needs.
- Identify areas of improvement for working in a cross-functional environment and ensure that these are discussed and implemented with the help of relevant teams.
- Provide support to any critical business projects with timely reporting of the progress to the business and/or cross-functional stakeholders.
- Focus on development and execution of operational plans with a broad level of alignment with department goals.
- Ensure that appropriate Standard Operating Procedures (SOP's) are in place for the teams to perform their actions. Approve SOPs wherever required.
- Management of budgets for biosimilar technical activities. Propose an annual budget and periodically review the budget in line with the technical services budget.
- Training, Learning & Development of the technical services team so that they are well equipped to perform any associated tasks.
- Identify suitable metrics to gauge performance; ensure implementation for the team and share these metrics with the wider business periodically.
- Other tasks as delegated by the Line Manager which contribute to the overall running of the function and supporting the wider business.
- 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.
- Consistently demonstrate and embody the company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” by working collaboratively across all business functions with 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 in chemistry, pharmacy, or other technically relevant graduate-level qualifications
- Master’s degree in chemistry, pharmacy; or other technically relevant graduate-level qualifications
- Prince 2 Certification and MS Project
Knowledge, Skills & Experience:
- Minimum 15 years of overall experience with at least 10 years of hands-on experience in a biologics or biosimilar technical role (Drug substance / Drug product/ Formulation and fill finish - development / Tech transfer / Production / LCM) within the pharmaceutical or biotechnology industry, preferably for regulated markets.
- Excellent technical knowledge base of biosimilar or biologic sterile pharmaceutical products from development of DS/ DP to commercial scale CMC aspects.
- Good understanding of biosimilar batch planning, manufacturing, packaging, testing and release arrangements with knowledge of product distribution and supply, especially working with CDMOs.
- Working knowledge of both upstream and downstream manufacturing processes for Biologics/ Biosimilars.
- Fully conversant with ICH guidelines requirements for Biologic / Biosimilar products.
- Open and adaptable to challenging environments.
- 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.
