Full-Time
Qualified Person for Clinical Trial Materials
Bulk Drug Product
AbbVie
10,001+ employees
Global biopharmaceutical company developing medicines
No salary listed
Ludwigshafen, Germany
Hybrid
Bachelor's
 Biology & Biotech (1) |
|---|
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- A pharmacist license or equivalent qualification meeting the requirements of §15 paragraphs 1 and 2 of the German Medicinal Products Act (AMG) is required.
- Several years of experience as a Qualified Person, primarily for chemically and/or biologically defined products and active substances, ideally for investigational medicinal products, are required.
- Expertise in quality assessment of active substances is required; expert knowledge under §15 paragraph 3a number 6 of the AMG is desirable.
- Expertise in quality assessment of Advanced Therapy Medicinal Products is required; expert knowledge under §15 paragraph 3a number 1 of the AMG is advantageous.
- Very good knowledge of national and international legal requirements, current Good Manufacturing Practice requirements, and applicable regulations is required.
- Very good knowledge of the development, manufacture, and testing of medicinal products is required.
- Strong analytical thinking and the ability to systematically analyze complex situations to identify problems and develop effective problem-solving strategies are required.
- The candidate must demonstrate sound judgment, decision-making ability, and professional conduct in critical and complex situations.
- The candidate must be able to collaborate effectively in cross-functional and global structures.
- Excellent communication skills in global and interdisciplinary environments are required.
- Very good written and spoken German and English are required.
- Perform the Qualified Person function in accordance with the German Medicinal Products Act §14, the Good Manufacturing Practice guidelines, and Regulation (EU) No 536/2014.
- Own batch release and Good Manufacturing Practice confirmation for investigational medicinal products and bulk products.
- Ensure the proper manufacture, testing, release, storage, and shipment of investigational medicinal products and imported products.
- Ensure compliance with legal requirements, alignment with Investigational New Drug and Investigational Medicinal Product Dossier submissions, and product quality and safety.
- Investigate and assess quality events, including root-cause analysis and pharmaceutical evaluation, and define and follow up on corrective and preventive actions.
- Assess changes to manufacturing processes, test methods, and relevant quality documents.
- Participate actively in interdisciplinary product development teams, including Chemistry, Manufacturing and Controls and supply-chain teams.
- Create and revise standard operating procedures and support the preparation and negotiation of Quality Agreements.
- Participate in audits and regulatory inspections and assess new regulatory requirements and due-diligence and in-licensing activities.
- Further develop the quality assurance system for investigational medicinal products and continuously optimize relevant processes.
- Initiate and support process-improvement measures to further strengthen efficiency and compliance.
- Further training as a specialist pharmacist is desirable, preferably in pharmaceutical analytics, pharmaceutical technology, or drug information.
- Knowledge of Lean Six Sigma and project management is advantageous.
AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.
Company Size
10,001+
Company Stage
IPO
Headquarters
North Chicago, Illinois
Founded
1888
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Simplify's Take
What believers are saying
- Q2 2026 revenue reached $16.99 billion, up 10.2%, with EPS of $3.65.
- AbbVie raised 2026 guidance to $13.87-$14.07 after broad strength across immunology and neuroscience.
- Rinvoq and Skyrizi both grew above 23% operationally, showing durable post-Humira momentum.
What critics are saying
- Humira sales fell 36.1% in Q2 2026; biosimilars keep compressing cash flows.
- Imbruvica dropped 29.4% in Q2 2026, exposing oncology weakness and IRA pricing damage.
- Apogee dilutes adjusted EPS through 2027; if Skyrizi stalls, AbbVie loses its bridge.
What makes AbbVie unique
- Skyrizi and Rinvoq delivered $8.0 billion in Q2 2026, replacing Humira.
- AbbVie completed Apogee on September 3, 2026, adding long-acting immunology assets.
- Etentamig posted 74% response in Phase 3 multiple myeloma, broadening oncology optionality.
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Benefits
Remote Work Options
Flexible Work Hours
Professional Development Budget
Growth & Insights and Company News
6 month growth
↑ 5%1 year growth
↑ 5%2 year growth
↑ 5%AbbVie has dramatically shifted its focus away from Humira, its once-flagship drug now facing biosimilar competition. On the company's July 2026 earnings call, Humira received just one sentence, noting global sales of $706 million, down 36.1% operationally but in line with expectations. This marks a stark change from previous quarters when management detailed the reasons behind Humira's decline, including biosimilar competition and molecule compression in the US market. AbbVie now emphasises growth drivers instead. Skyrizi generated $5.5 billion in Q2 2026, whilst Rinvoq exceeded $2.5 billion, both growing above 20% operationally. The company also acquired Apogee Therapeutics in September 2026. Despite the reduced attention, Humira still contributes approximately 4% of AbbVie's quarterly revenue of nearly $17 billion, though management no longer publicly projects its ultimate decline trajectory.
Israel Englander's Millennium Management more than doubled its stakes in AbbVie and Costco during the second quarter. AbbVie's revenue grew 10.2% year-over-year to $17 billion in Q2, driven by immunology drugs Skyrizi and Rinvoq. The company recently acquired Apogee Therapeutics for $10.9 billion in cash and is developing ABBV-295, a monthly weight-loss treatment. AbbVie is a Dividend King with over 50 consecutive years of payout increases. Costco's Q3 fiscal 2026 revenue rose 11.6% to $70.5 billion, with comparable sales up 9.8%. The company has raised dividends for 22 consecutive years. However, Costco shares are down 4% over the past year whilst trading at 40.8 times forward earnings, above the consumer staples average of 21.6 times. Both companies maintain strong fundamentals despite different market challenges.
AbbVie offers a smarter long-term dividend investment than Pfizer, despite Pfizer's higher 6.1% yield. AbbVie holds Dividend King status with 53 consecutive years of dividend increases and raised its payout by 5.5% this year to $1.73 per share. Over the past decade, AbbVie increased its dividend by more than 203% compared to Pfizer's 51%. AbbVie's revenue grew 138% during this period, whilst Pfizer's rose just 18%. AbbVie successfully navigated Humira's patent cliff through home-grown immunology drugs Skyrizi and Rinvoq. By 2025, these two drugs generated combined annual sales exceeding $25 billion, replacing Humira's peak revenue and pushing total company revenue to record highs. AbbVie's free-cash-flow dividend payout ratio stands at 65%, lower than Pfizer's 89%.
The Manufacturers Life Insurance Company acquired a $655.27 million stake in AbbVie Inc., according to its latest SEC Form 13F filing. Other institutional investors also increased their positions significantly during the same period. Norges Bank acquired a new $5.87 billion position, whilst Wellington Management Group boosted its holdings by 457.4%. AbbVie reported quarterly earnings per share of $3.65, exceeding forecasts, with revenue growth of 10.2% year over year. The company generated $16.99 billion in revenue last quarter, surpassing expectations. Equity analysts maintain a bullish outlook. Barclays, Wolfe Research, and BMO Capital Markets each set price targets of $300, with ratings of "overweight" or "outperform". The consensus rating is "Moderate Buy". Institutional investors currently hold 70.23% of AbbVie's shares, reflecting confidence in the biopharmaceutical company's strategy and performance.
AAPS PharmSci 360: CMC strategies, part 1. In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discussed how CMC review practices are evolving and what that means for manufacturing strategy. PharmTech spoke with Alfred Rumondor, PhD, CMC due diligence for external assets at AbbVie, and Swita Singh, PhD, Senior Director and Strategic CMC Leader at Bristol Myers Squibb, to learn more about their upcoming panel discussion, Navigating CMC Strategy in the Current Landscape, at, which is being held from October 25-28 in New Orleans. In part 1 of this 3-part interview, Rumondor and Singh discussed how chemistry, manufacturing, and controls (CMC) review practices are evolving and what that means for manufacturing strategy. Singh identified the most consequential shift as a move from informal, reviewer-dependent flexibility to formal, risk-based flexibility applied consistently across the product life cycle. She pointed to Operation TrailBlazer and updated phase 1 CMC guidance as examples, stating they are reducing required manufacturing data pre-investigational new drug application (IND). Singh also pointed out that cell and gene therapy programs no longer need 3 independent process performance qualification batches and can flex specifications for small-batch production. AI-driven tools and emerging credibility frameworks are reinforcing this trend by helping generate cleaner data packages for faster, more consistent regulatory decisions. Singh cautioned, however, that companies must build "risk justification muscle" rather than simply accepting flexibility at face value. Reduced requirements should be treated as deferral, not elimination, of data obligations; organizations need clear plans for when deferred data will be generated and which milestones trigger it. She emphasized investing early in comparability infrastructure, leveraging platform and prior-knowledge pathways, and engaging proactively with regulators. Rumondor addressed the pressure to compress development timelines. He argued the real question isn't whether compression is safe, but how to do it properly by working smarter rather than skipping steps. He cited premature form selection without adequate screening as a common shortcut that later may bring costly bridging and comparability studies, increasing both timeline and program risk. Compressed timelines are achievable, but only when teams rigorously plan the full development path upfront, according to Rumondor. About the speakers. Alfred Rumondor, PhD, is Director, Development Sciences Licensing and Acquisitions, at AbbVie. Dr. Swita Singh holds a Ph.D. in Pharmaceutical Sciences and brings over fifteen years of distinguished expertise in Chemistry, Manufacturing, and Controls (CMC) development across biologics, antibody drug conjugates, and small molecules, with a proven record of driving strategic initiatives, optimizing complex business processes, and leading cross-functional teams to achieve regulatory and operational excellence. Recognized for delivering innovative, end-to-end CMC strategies that guide programs from early clinical development through successful commercialization, she has cultivated talent and shaped organizational culture throughout her career, while her commitment to stakeholder communication and cross-functional collaboration has consistently advanced program objectives across the industry. Having built her expertise at Pfizer and Eli Lilly and Company, Dr. Singh currently serves at Bristol Myers Squibb (BMS), where she continues to lead CMC strategy in support of transformative therapeutic development.