Biotechnology Job At ADVANZ PHARMA
Are you searching for a rewarding Biotechnology Job in the pharmaceutical and biosimilars industry? ADVANZ PHARMA has announced an exciting opportunity for the position of Technical Specialist – Technical Support in Mumbai. This prestigious ADVANZ PHARMA Job offers biotechnology and pharmacy professionals the chance to work with complex sterile biologics, biosimilars, manufacturing technologies, regulatory compliance, and global technical operations. If you are looking to accelerate your Life Science Careers with an internationally recognized pharmaceutical organization, this opportunity deserves your attention.
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines.
The company’s ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines across Europe, Canada, and Australia. To achieve this, ADVANZ PHARMA partners with innovative biopharmaceutical and pharmaceutical development companies to bring medicines to patients.
Job Details:
- Position: Technical Specialist – Technical Support
- Location: Andheri, Mumbai, India (Hybrid Working)
- Company: ADVANZ PHARMA
Biotechnology Job Overview
ADVANZ PHARMA is seeking a Technical Specialist – Technical Support to ensure a consistent and reliable supply of complex sterile biological and biosimilar products. The role involves providing expert technical guidance to contract manufacturers, troubleshooting manufacturing challenges, conducting due diligence assessments, supporting lifecycle management activities, and leading technical projects such as site transfers, material changes, and process improvements.
The position also serves as a key technical resource for internal stakeholders, supports compliance with licensing and manufacturing standards, and contributes to strategic decision-making through technical expertise and risk assessment.
Role Purpose
The purpose of this role is to ensure a consistent and reliable supply of complex sterile biological and biosimilar products by providing technical expertise and support to contract manufacturing organizations.
The role involves:
- Troubleshooting manufacturing challenges
- Conducting technical due diligence assessments
- Supporting lifecycle management activities
- Managing manufacturing and process changes
- Providing compliance support
- Acting as a subject matter expert across technical and cross-functional areas
The incumbent will communicate complex technical concepts, anticipate business and manufacturing risks, and influence strategic decisions that impact product supply and operational excellence.
Key Responsibilities
Technical Expertise & Subject Matter Leadership
- Demonstrate expert knowledge in technical and manufacturing domains related to:
- Sterile pharmaceutical products
- Biological products
- Biosimilars
- Broader GxP environments
- Serve as a subject matter expert during:
- Health authority inspections
- Cross-functional discussions
- Act as the primary point of contact for technical matters within the assigned area.
Technical Documentation & Regulatory Support
- Independently author, review, and approve technical documentation, including:
- Technical Justifications
- Requests for Information (RFI) Responses
- Technical Summary Reports
- Complex Regulatory Submission Documents
- Support regulatory activities by providing technical expertise and documentation.
Manufacturing Support & Troubleshooting
- Provide technical solutions during manufacturing troubleshooting activities.
- Support lifecycle management activities for:
- Existing commercial products
- Newly introduced products
- Resolve complex manufacturing and production challenges.
Due Diligence & Risk Assessment
- Lead due diligence reviews for:
- New products
- Product acquisitions
- Manufacturing changes
- Conduct risk assessments relating to:
- Manufacturing processes
- Packaging operations
- Validation activities
- Evaluate potential technical and operational risks.
Project Management
Lead and manage complex projects, including:
- Site Transfers
- Material Source Changes
- Reformulation Activities
- Process Improvement Initiatives
Project Responsibilities
- Manage assigned lifecycle maintenance projects.
- Ensure timely project execution and reporting.
- Monitor project progress and stakeholder alignment.
- Drive successful completion of technical initiatives.
Compliance & Technical Services
- Provide technical services and expert support to internal stakeholders.
- Support:
- Licensing Compliance
- Manufacturing Compliance
- Regulatory Compliance
- Ensure alignment with quality and operational requirements.
Contract Manufacturer Support
- Provide on-site technical support to contract manufacturing organizations.
- Support continuous improvement of supply reliability for complex and difficult-to-manufacture products.
- Collaborate with external manufacturing partners to resolve technical issues.
Batch Manufacturing & Release Decision Support
- Lead technical decision-making related to:
- Batch Manufacturing Progression
- Product Release Activities
- Product Write-Off Decisions
- Collaborate with cross-functional stakeholders during decision-making processes.
- Participate actively in technical review meetings.
Strategic Problem Solving
- Anticipate internal and external business challenges.
- Develop innovative solutions to complex manufacturing and production issues.
- Deliver recommendations that significantly impact business performance and supply continuity.
Data Analysis & Process Improvement
- Analyze data and performance indicators (KPIs).
- Generate insights from operational data.
- Drive improvements in existing manufacturing and technical processes.
- Participate in continuous improvement initiatives beyond the immediate technical function.
Training & Mentoring
- Train and mentor:
- Internal Teams
- External Teams
- Support capability building and knowledge transfer activities.
Budget Management
- Independently perform cost-benefit analyses.
- Manage departmental budgets.
- Support budget forecasting and reforecasting activities.
- Identify process improvements that enhance budget efficiency.
Additional Responsibilities
- Execute additional tasks delegated by the Line Manager.
- Contribute to the effective operation of the business unit.
- Demonstrate accountability for assigned responsibilities and business outcomes.
Behavioral Expectations
The successful candidate will be expected to:
- Thrive in an entrepreneurial environment.
- Take ownership and accountability for results.
- Embrace challenges and change.
- Apply a growth mindset approach.
- Demonstrate a bias for action and fast decision-making.
- Consistently embody the company’s values:
- Entrepreneurship
- Speed
- Integrity
- Promote the spirit of “One Team” through collaboration and mutual respect.
- Contribute to making ADVANZ PHARMA a preferred workplace.
Educational Qualifications
Candidates should possess:
Essential Qualification
- Bachelor’s or Master’s Degree in Biotechnology
Additional Qualifications
- Prince2 Certification
- MS Project Knowledge
Knowledge, Skills & Experience
Industry Experience
Candidates must possess significant experience in technical roles within the pharmaceutical or biotechnology industry, including:
- Drug Substance Development
- Drug Product Development
- Technology Transfer
- Production
- Lifecycle Management (LCM)
Experience in regulated markets is preferred.
Technical Expertise
Strong expertise in:
- Sterile Pharmaceutical Products
- Biologics
- Biosimilars
- Product Development
- Commercial Manufacturing
- Process Validation
- Batch Manufacturing
- Batch Release Activities
Regulatory Knowledge
Demonstrated experience in:
- Authoring and reviewing regulatory documentation
- eCTD Module 3 submissions
- Quality Overall Summaries (QOS)
- Expert Statements
Strong understanding of:
- Global Regulatory Requirements
- Good Manufacturing Practices (GMP)
- Process Validation
- Manufacturing Compliance
Project Management
- Experience managing complex scientific and technical projects.
- Working knowledge of project management methodologies and tools.
Technical & Software Skills
- Proficiency in Microsoft Excel
- Proficiency in Microsoft PowerPoint
- Strong data analysis capabilities
Communication Skills
Ability to:
- Communicate clearly and concisely
- Present technical concepts effectively
- Prepare high-quality written documentation
- Convey facts, figures, and ideas to diverse stakeholders
Personal Attributes
The ideal candidate should demonstrate:
- Adaptability in challenging environments
- Positive and solution-oriented attitude
- Commitment to continuous improvement
- Strong learning agility
- Scalability and growth mindset
- Collaborative working style
- Respectful and transparent communication
- Ability to thrive in a fast-paced and evolving environment
Why Join ADVANZ PHARMA?
ADVANZ PHARMA believes that its success is driven by its people.
The company fosters an environment where employees are empowered to:
- Act as entrepreneurs
- Embrace challenges
- Drive innovation
- Contribute to company growth
- Develop personally and professionally
Diversity & Inclusion
ADVANZ PHARMA values diversity and actively promotes inclusion across the organization.
Key initiatives include:
- ADVANZ PHARMA Women’s Network
- Active encouragement of women into leadership positions
- Approximately 40% of managers are women
Compensation & Benefits of Biotechnology Job
Employees can expect:
- Flexible and agile working arrangements
- Competitive salary package
- Comprehensive benefits
- Career advancement opportunities
- Inclusive and collaborative workplace culture
