PHARMAFull time
Biologics Process Expert
By Admin · Research & Development (Lab & Science)
CHENNAI (IN)HYBRIDPOSTED: 11/8/2026
PHARMAFull time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE OVERVIEW
AstraZeneca is hiring a Biologics Process Expert in Chennai to lead drug substance and drug product shipping validation across development and commercial supply. The role combines protein science, transport-stress study design and AI-enabled modelling to protect product quality through distribution.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead drug substance and drug product shipping validation strategy from development through commercial supply.
- •Design, execute, interpret and document transport studies covering temperature excursions, vibration, shock, handling stress, freeze-thaw, agitation and shear, and translate results into acceptance criteria.
- •Apply understanding of biologics degradation mechanisms such as aggregation, particle formation, denaturation, potency loss and container closure interactions to set controls and mitigations.
- •Develop and apply mechanistic, statistical and digital models, including AI-enabled tools and advanced analytics, for transport risk assessment and validation design.
- •Automate and standardise experimental set-up, data analysis and technical reporting to improve speed and reproducibility.
- •Identify, evaluate and implement innovative shipping technologies, packaging configurations, lane strategies, monitoring tools and distribution models.
- •Collaborate with formulation, analytical, manufacturing, packaging, supply chain, quality, regulatory teams and external logistics providers on requirements and implementation plans.
- •Author protocols, reports, risk assessments and comparability documentation, support deviation investigations and root cause analysis, and mentor colleagues on standards and digital tools.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Advanced degree in chemical engineering, biochemical engineering, pharmaceutical sciences, biotechnology, biophysics or a related subject area.
- A PhD and/or graduate degree or equivalent experience with 1–3 years is preferred; a master's degree with 3–8 years of experience will also be considered.
- Experience in biologics process development, formulation development, manufacturing sciences or technical operations, with strong exposure to shipping validation for drug substance and/or drug product.
- Demonstrated expertise in biologics stability and product quality impacts associated with mechanical stress, agitation, shear, vibration, shock and temperature excursions.
- Strong understanding of protein science and how process and transport conditions affect biologics attributes.
- Knowledge or experience of shipping validation study building, transportation risk assessments and interpretation of complex technical data.
- Understanding or working knowledge of ISTA standards and their practical application in pharmaceutical or biologics transportation studies.
- Understanding or experience applying modelling, simulation, statistics or digital tools to process understanding or validation activities.
- Experience using or implementing AI-enabled tools, advanced analytics or data-driven approaches to improve scientific workflows, decision-making or process performance.
- Strong technical writing and documentation skills, with experience preparing reports and technical justifications.
- Ability to work effectively across multidisciplinary, global teams and influence without direct authority.
PREFERRED QUALIFICATIONS
- •Experience in both drug substance and drug product operations, including interactions between upstream/downstream processing, formulation, fill-finish, packaging, storage and distribution.
- •Familiarity with cold chain logistics, cryogenic or frozen transport, and controlled temperature shipping systems for biologics.
- •Experience with container closure systems, single-use systems, bulk drug substance transport and final packaged product distribution.
- •Knowledge of computational modelling, DOE, multivariate analysis or digital twins relevant to process or transport simulations.
- •Experience in regulatory inspections, submissions or health authority interactions related to process validation, comparability or distribution robustness.
- •Understanding of GxP, quality risk management and lifecycle validation principles.
- •Experience driving digital transformation or operational excellence initiatives in pharmaceutical or biologics environments.
REQUIRED VERIFIED SKILLS
Biologics process development
Shipping validation
Protein science
Biologics stability
Transportation risk assessment
ISTA standards
Modelling and simulation
Statistics
AI-enabled tools
Advanced analytics
Technical writing
Cross-functional collaboration
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a science-led biopharmaceutical company operating a global, end-to-end network that turns molecules into medicines. It invests in technology, automation and digitalisation across its operations.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
APPLICATION ADVISORY
Lead with concrete examples of shipping validation studies you have designed or executed for drug substance or drug product, and name the transport stresses you characterised (vibration, shock, shear, freeze-thaw, temperature excursion). Show where you have applied ISTA standards, transport risk assessment and protein degradation knowledge to set acceptance criteria. Also highlight any modelling, statistical, DOE or AI-enabled analytics work you used to speed up validation or data interpretation.
SPONSORED · TRAINING
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