Strahinja Lucic
Frankfurt am Main
Summary
Analytically driven scientist with five years of progressive, hands-on experience across parenteral drug manufacturing, packaging operations, and GxP quality assurance and control, spanning site-level execution to multi-market coordination. Proven ability to translate complex scientific and operational challenges into structured, compliant, and actionable solutions. Skilled at providing technical direction and driving alignment across Quality, Regulatory Engineering, Production and Supply Chain. Known for strong technical writing, regulatory interaction support, and capability building at all organizational levels. Outside of work, active as a classical pianist and competitive athlete, where discipline, resilience, and team spirit shape my working approach.
Overview
7
7
years of professional experience
Work History
GIG as an Analytical Expert in Quality Control
Sanofi Aventis Germany GmbH
05.2026 - Current
- Novel Therapeutic Support: Supported pipeline innovation for a first-in-class autoimmune therapeutic by designing comprehensive, risk-based stability testing protocols for New Product Introduction (NPI) aligned with ICH guidelines and regulatory expectations, directly contributing to accelerated time-to-market and regulatory approval strategy, reducing the cycling study time by a third
- Global Network Coordination: Managed multi-site collaboration between Frankfurt BioCampus, Sanofi Geel, and external research partners; provided expert technical support on advanced bioanalytical methods (UHPLC, CE-SDS, bioassays) for product characterization and QC release activities
- Regulatory Compliance: Authored Common Technical Document (CTD) Module 3 (3.2.P.8) stability sections, including long-term, accelerated, cycling, and photostability protocols for NPI submissions across EU, US, China and Japan markets
Launch Expert in Packaging
SADG
01.2026 - Current
- Global Launch & Compliance Oversight: Ensured on-time, GMP-compliant packaging readiness (secondary and tertiary packaging) for high-value international launch products including drug device combination products and prefilled devices (Sarclisa SC, Kevzara, Tzield, Rilpibrut, Amiltelimab), directly enabling commercial timelines and revenue realization across EU, USA, and Japan markets, including successful commercial launch of a product within 24 hours of US FDA regulatory approval; managed simultaneous coordination of six products across four packaging lines and 16 markets with direct business impact on product availability
Compliance Expert in Sterile Filling
SADG
08.2024 - 01.2026
- Inspection & Regulatory Readiness: Served as technical Subject Matter Expert (SME) during two self-inspections and one regulatory inspection with zero critical findings related to aseptic filling and visual inspection processes of Drug Product, ensuring DP control strategies remained compliant with global cGMP expectations
- Aseptic Process Support: Provided second-level technical oversight of DP aseptic filling operations (cartridges and vials) as deputy manufacturing manager, including batch documentation review and approval to ensuring GMP compliant, release-ready product
- Process Validation: Supported validation and lifecycle management of filling equipment, personnel, and processes (APS); reviewed and approved manufacturing instructions and Master Batch Records (MBR); authored Annual Product Reviews (APR); maintained technical documentation throughout product lifecycle
- Container Closure Integrity Science: Served as technical expert for CCIT across primary packaging (vials, cartridges and syringes); authored CCIS SOPs grounded in risk-based principles; designed and delivered training on in-process-control methods (visual inspection, leak detection, sliding/gliding force) for all shift members, building sustainable in-house CCIT expertise
- Quality Culture & Capability Building: Mentored and supervised two trainees in GMP and QRM principles, achieving 100% first-time pass rate on GMP qualification assessments; fostered a strong quality culture and developed technical talent
- Data-driven Process Optimization & Measure Implementation: Applied Lean methodology principles to continuous improvement initiatives of environmental and personnel monitoring sampling strategy in controlled cleanroom environments (Grade A/B); analyzed monitoring data to assess system performance, derive risk-based alert limits, and strengthen process robustness; verified effectiveness of implemented measures through quantitative KPIs and trend analysis, achieving a reduction of environmental and personnel monitoring deviations to zero per month following implementation of the revised sampling strategy; trained shift personnel across compounding, fill & finish, maintenance, quality control and cleaning, a total of 160 staff members
- Digitalization & Real-Time Production Monitoring: Led the digitalization of the production board from a manual to an electronic, real-time system, accelerating decision-making and providing all stakeholders with immediate, transparent access to production status and results; improved data integrity and shortened the batch documentation review cycle by reducing documentation errors
Implementation Expert in Cleaning Analytics
SADG
01.2023 - 08.2024
- End-to-End Strategic Project Leadership & Product Launch: Designed and led the strategic roadmap for Total Organic Carbon (TOC) analytics implementation in the API unit (Lantus and MIB) from business case development through operational rollout; owned planning, resource and budget responsibility, and technical execution; delivered measurable business impact through ~50% reduction in manual sampling, improved compliance and enhanced process control
- Method Development & Validation: Owned technical validation strategy for TOC analytics from experimental planning through operational implementation; independently designed and executed DoE-based laboratory experiments for method development and optimization; defined acceptance criteria, and authored transfer/validation protocols, supporting robust, compliant lifecycle management in a GxP environment
- System Integration & Automation: Managed computerized System Validation (CSV) of TOC analytics; coordinated LIMS integration; led the implementation of a real-time Process Analytical Technology (PAT) monitoring solution from concept through deployment, enabling data-driven decision-making in manufacturing and predictive process monitoring
- Global Quality Interface & Stakeholder Management: Served as Single Point of Contact (SPOC) between Global functions, Quality, Production, MSAT, and TPM across four sites; facilitated cross-hierarchical governance alignment and drove decision-making on complex compliance and quality matters through structured stakeholder engagement, conflict resolution, and influence without formal authority
- Cluster Cleaning: Comprehensive bioprocess expertise in biotechnological API manufacturing (Drug Substance) of insulins across up-, mid-, and downstream processes (fermentation, harvest, purification); familiarity with process control systems, equipment (fermenters, mixing vessels, separators, columns), process parameters, and quality requirements; close technical collaboration with Engineering for creating flowing diagrams (P&IDs) and contributing to filter and CIP/SIP concepts for media distribution
Consultant
agap2
10.2021 - 12.2022
- Core Competencies: Rapid onboarding into complex client environments; flexible deployment across multiple pharmaceutical and biotech organizations; ability to quickly assess quality systems, identify gaps, and deliver actionable recommendations that create immediate value
- Sanofi: Provided strategic technical advisory on cleaning validation and analytical method implementation
- Sartorius AG: Led equipment qualification and process validation projects for bioprocessing equipment
- Gilead Sciences / MYR GmbH: Delivered Pre-Approval Inspection (PAI) readiness consulting; prepared organization for regulatory inspections and ensured GMP compliance under tight timelines
- A pharma-specialized consulting and staffing firm
Project Management Officer (PMO)
GSI Helmholtz Center for Heavy Ion Research
05.2019 - 09.2021
- Project Management & Quality Assurance: Coordinated R&D project activities between research institutions, universities, and laboratories
- Technical System Responsibility: Contact person for facility technical systems, including vacuum/cryogenic technology and electrical/testing equipment
- Safety Management: Developed safety concepts for physical experiments and facility operations
Education
Master of Science - Chemistry, with strong focus on physical and analytical sciences
Johann Wolfgang Von Goethe – Universität
Frankfurt am Main09.2018
Skills
- Languages: English (fluent), German (fluent), Serbian (native)
- IT Systems & Tools: SAP (ERP), LIMS, MES, MBDIS, Veeva Vault, MS Office Suite, Sharepoint, OnePack, Shine, Scada, Power BI
- Process Ownership: Control strategy development, QC release testing, process development, analytical method development and validation, stability testing, data integrity, experimental design (DoE), Quality by Design (QbD), supplier qualification, batch record approval, process validation and technology transfer, change control, deviation/CAPA /OOS - OOT management, lifecycle management, CCIT methodologies, Lean methodologies, business case development
Personal Interests
Piano: Since 2002, classical and chamber music, concerts in theaters, conservatories, and performance spaces, Water Polo: Regional League (2003 – 2024), 2nd Bundesliga SVW05 (since 2025), leadership role in the team
Section name
- Internal
- Strahinja Lucic | Ferdinand-Happ-Straße 11 | 60314 Frankfurt am Main | Tel. 015780611232
Personal Information
Nationality: German
Timeline
GIG as an Analytical Expert in Quality Control
Sanofi Aventis Germany GmbH
05.2026 - Current
Launch Expert in Packaging
SADG
01.2026 - Current
Compliance Expert in Sterile Filling
SADG
08.2024 - 01.2026
Implementation Expert in Cleaning Analytics
SADG
01.2023 - 08.2024
Consultant
agap2
10.2021 - 12.2022
Project Management Officer (PMO)
GSI Helmholtz Center for Heavy Ion Research
05.2019 - 09.2021
Master of Science - Chemistry, with strong focus on physical and analytical sciences
Johann Wolfgang Von Goethe – Universität