Technical Specialist, Technical Support

Advanz Pharma Corp; Mumbai; On-site; INR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Flexible working options

Competitive salary and benefits package

Job summary

Advanz Pharma Corp is seeking a skilled professional to ensure the reliable supply of complex sterile biological and biosimilar products. The ideal candidate will provide expert technical guidance and manage various key projects, including troubleshooting and site transfers.

Candidates must have a degree in pharmacy or biotechnology and significant experience in the pharmaceutical industry, focusing on biologics. Emphasizing a positive approach and strong collaboration skills, this role offers a competitive salary and benefits package, along with flexible working arrangements.

Qualifications

• Must have significant experience in a technical role within the pharmaceutical or biotechnology industry.
• Proven experience managing complex scientific and technical projects.
• Strong writing and verbal communication skills required.

Responsibilities

• Ensure a consistent supply of complex sterile biological and biosimilar products.
• Lead due diligence risk analysis for new products and acquisitions.
• Provide on-site support to contract manufacturers.

Skills

Expert knowledge in biologics and biosimilars

Strong technical expertise in regulatory documentation

Ability to provide technical solutions

Project management skills

Education

Bachelor’s or Master’s degree in pharmacy or biotechnology

Tools

MS Project

Job description

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.

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.

Benefits

We offer flexible, agile working options, and provide a highly competitive salary and benefits package.