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Hovione

CDMO for complex drug APIs manufacturing

Principal QC Specialist

Full-TimeDeadline 10/2/27
No salary listed
Expert
Bachelor's
Lisbon, Portugal
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A degree in Microbiology, Pharmacy, Biological Sciences, Biotechnology, Life Sciences, or a related scientific discipline is required.
  • Advanced knowledge of microbiology applied to pharmaceutical manufacturing environments is required.
  • Strong knowledge of global GMP requirements, including EU GMP Annex 1, FDA, PIC/S, ICH, and other applicable regulatory requirements and guidance is required.
  • Fluency in English is required.
  • Strong technical writing, communication, and influencing skills are required.
  • Computer literacy and good working knowledge of the Microsoft Office suite are required.
  • A minimum of 10 years of experience within the pharmaceutical industry and/or CDMO environment is required.
  • Extensive experience in microbiology, contamination control, sterility assurance, and GMP-regulated manufacturing environments is required.
  • Demonstrated experience supporting both aseptic and non-aseptic manufacturing operations is required.
  • Significant experience supporting small molecule and biotechnology products, including development, scale-up, technology transfer, and commercial manufacturing activities is required.
  • A strong understanding of the microbiological, contamination control, and regulatory challenges associated with both chemical and biological manufacturing processes is required.
  • Experience with environmental monitoring, cleanroom operations, microbial contamination investigations, utilities microbiological control, and cleaning and disinfection programs is required.
  • Experience supporting regulatory inspections, customer audits, and health authority interactions is required.
  • Demonstrated ability to influence stakeholders and drive alignment across multiple functions, disciplines, and geographical locations without direct authority is required.
  • Experience leading complex global initiatives and driving harmonization of standards, procedures, and best practices across multiple sites is required.
  • Strong risk-management, problem-solving, and decision-making capabilities are required.
  • Knowledge of industrial safety principles and the application of Risk Management and Lean Six Sigma methodologies in GMP environments is required.
Responsibilities
  • Act as the company's global technical authority for microbiology and contamination control matters.
  • Lead the development, maintenance, and continuous improvement of global policies, standards, and procedures related to microbiology, contamination control, and sterility assurance.
  • Monitor evolving regulatory requirements, industry guidance, and health authority expectations, ensuring timely incorporation into Hovione's Quality System.
  • Drive harmonization and standardization of microbiological and contamination control practices across all Hovione sites.
  • Provide expert support to Manufacturing, Quality, Engineering, Technical Services, and R&D teams on microbiological and contamination control matters.
  • Support investigations, risk assessments, deviations, CAPAs, and change controls involving microbiological contamination risks.
  • Support customer audits and regulatory inspections as the company's SME in microbiology and contamination control.
  • Identify, assess, and deploy industry best practices to ensure a science- and risk-based approach across the organization.
  • Deliver training, coaching, and technical guidance to strengthen microbiological and contamination control capabilities throughout the organization.
  • Lead global initiatives and cross-functional projects with significant impact on product quality, compliance, patient safety, and operational excellence.
  • Facilitate effective communication and collaboration across sites to identify opportunities for continuous improvement and consistent implementation of standards.

About the company

Hovione is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture active pharmaceutical ingredients (APIs). It specializes in complex chemistry and manufacturing techniques such as particle engineering and spray drying to improve how drugs are absorbed. The company stands out through a long history, a focus on difficult-to-make compounds, and a global footprint with FDA-inspected sites in Portugal, Ireland, China, and the United States, built from a private, family-owned background. Its goal is to enable partners to bring new medicines to market efficiently by providing high-quality, scalable manufacturing capacity and continuous investment in capabilities.

Company Size

1,001-5,000

Company Stage

N/A

Total Funding

N/A

Headquarters

Loures, Portugal

Founded

1959

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Simplify's Take

What believers are saying

  • September 16, 2026, Hovione opened 89 Twin Rivers, doubling U.S. spray-drying capacity.
  • March 2025's Seixal campus targets mid-2027 commissioning and fresh manufacturing capacity.
  • April 1, 2027, Stefan Doboczky becomes CEO after Hovione's succession review.

What critics are saying

  • May 11, 2026, Jean-Luc Herbeaux left; co-CEOs run Hovione until April 2027.
  • Seixal's 2027 launch demands flawless execution after Loures reached physical limits.
  • U.S. customers fund 60% of sales, so FDA delays hit 2026 growth immediately.

What makes Hovione unique

  • Hovione owns spray drying, tableting, and drug-product manufacturing under one quality system.
  • Its East Windsor and Loures campuses integrate amorphous solid dispersions with commercial-scale output.
  • The 2026 intranasal platform pairs API development with patented device supply.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Paid Vacation

Company News

Scientist Live
Oct 7th, 2026
Hovione to develop new continuous tabletting line.

Hovione to develop new continuous tabletting line. Published: 7 October 2026 CDMO Hovione is commissioning a continuous tabletting line called ConsiGma CDC Flex at its New Jersey campus in late 2027. The $35m project will be installed at Hovione's recently opened facility, 89 Twin Rivers. Once installed, it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. Continuous tabletting is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients are crucial. "Hovione will be the first company in the world to offer the ConsiGma CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tabletting," said Hovione co-CEOs Marco Gil and António Almeida. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." ConsiGma CDC Flex will operate in continuous or batch modes across a broad throughput range of 1 to 200kg/h. Operators will be able to develop a formulation using quantities of material as small as 1.5kg, and then run from small clinical batches to large commercial batches with the same equipment. Specialised design enables the switch between continuous blenders of various sizes. The line will be installed for containment to 1 μg/m[3], supporting highly potent compounds. "Installing the CDC Flex at 89 Twin Rivers makes continuous tabletting part of an integrated U.S. development and manufacturing workflow," said David Basile, VP of Technical Operations, Americas for Hovione. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Developed jointly with GEA, the ConsiGma CDC Flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply.Inline process analytical technology and automated controls also provide real-time quality monitoring.

Contract Pharma
Oct 5th, 2026
Hovione invests $35M in world's first ConsiGma CDC Flex tableting line.

Hovione invests $35M in world's first ConsiGma CDC Flex tableting line. The next-generation continuous manufacturing platform will launch at Hovione's East Windsor, New Jersey, campus in late 2027. October 5, 2026 Associate Editor, Contract Pharma Editor's Take: As pharmaceutical companies strive to bridge scientific breakthroughs with practical delivery, oral solid dosage development and manufacturing has become a focal point for modernization. Global CDMO Hovione will commission the world's first ConsiGma CDC Flex, a next generation continuous tableting line, at its East Windsor, New Jersey campus in late 2027. The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. "Hovione will be the first company in the world to offer the ConsiGma CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs of Hovione. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." The new ConsiGma CDC Flex will operate in continuous or batch modes across a very broad throughput range (from 1 to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialized design within the ConsiGma CDC Flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 μg/m[3], supporting highly potent compounds. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated U.S. development and manufacturing workflow," added David Basile, Vice President of Technical Operations, Americas for Hovione. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Developed jointly with GEA, the ConsiGma CDC Flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these developments are designed to simplify operation, improve efficiency and containment, and enhance operator safety. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Citybiz
Sep 16th, 2026
Hovione opens New Jersey facility, doubling U.S. Spray drying capacity.

Hovione opens New Jersey facility, doubling U.S. Spray drying capacity. September 16, 2026 Marco Gil, co-CEO Hovione; Janice Mironov, Mayor East Windsor, NJ; Debbie Hart, President BioNJ; Antonio Almeida, co-CEO Hovione; David Basile, VP TechOps Americas Hovione Hovione has opened a new 31,000-square-foot pharmaceutical manufacturing facility at its East Windsor, New Jersey, campus, doubling the contract development and manufacturing organization's U.S. spray drying capacity and completing a $100 million investment cycle in the state. The facility, known as 89 Twin Rivers, adds two GMP-ready, commercial-scale PSD-3 spray dryers to Hovione's U.S. operations. The expansion strengthens the company's ability to move pharmaceutical programs from formulation screening through scale-up and commercial manufacturing of spray-dried amorphous solid dispersions within a single site and quality system. The project also adds approximately 80 jobs and represents the first major milestone in Hovione's longer-term plan to develop East Windsor into a larger pharmaceutical development and manufacturing hub. Spray drying has become an important manufacturing technology for drug developers confronting poor aqueous solubility, which can limit how effectively an active pharmaceutical ingredient is absorbed. Hovione estimates that approximately 70% of small-molecule drug candidates face this problem. The company uses spray drying to produce amorphous solid dispersions that can improve the bioavailability of poorly soluble drug ingredients. Hovione has more than 25 years of experience with the technology, combining formulation science, predictive and model-based development, manufacturing scale-up and finished drug product capabilities. The new capacity sits within a broader integrated platform spanning drug substance, particle engineering and drug product manufacturing. Because 89 Twin Rivers operates under the East Windsor campus' existing FDA registration and harmonized quality system, Hovione said customers can reduce technology transfers as programs advance from development into commercial production. That continuity is increasingly relevant to pharmaceutical companies looking to shorten development timelines and reduce manufacturing risk for complex products. Rather than transferring a formulation among separate development and production sites, Hovione is building capacity to support multiple stages of a program within a common operating environment. "Opening 89 Twin Rivers is more than a capacity expansion," co-CEOs Marco Gil and Antonio Almeida said. "It marks the next chapter in Hovione's legacy of more than two decades in the U.S." They said the investment is intended to meet growing demand for pharmaceutical spray drying while providing customers with a more direct pathway from drug substance through finished drug product. Hovione is already planning another significant expansion in East Windsor. Over the next five to 10 years, the company intends to develop roughly 15 acres of adjacent property with a 125,000-square-foot manufacturing facility. Plans for that site include additional laboratories, commercial-scale spray drying and drug product manufacturing. Hovione also plans to offer customers the ability to co-invest in the expansion in exchange for priority access to its technology platforms, engineering capabilities and accelerated capital deployment for their programs. The strategy positions East Windsor as a larger component of Hovione's international manufacturing network at a time when pharmaceutical companies are placing greater emphasis on regional production capacity and supply-chain resilience. Hovione is pursuing a network of autonomous but harmonized development and manufacturing operations across North America, Europe and Asia. Recent investments in Portugal and Ireland complement the New Jersey expansion and are intended to support regionalized supply and dual-site manufacturing using consistent technologies and quality systems. "89 Twin Rivers is a major step forward for Hovione's U.S. operations and a clear expression of our long-term commitment to East Windsor and New Jersey," said David Basile, vice president of technical operations, Americas. East Windsor Mayor Janice S. Mironov and BioNJ President Debbie Hart joined Hovione executives for a ribbon-cutting ceremony on September 15. Hovione currently works with 19 of the world's 20 largest pharmaceutical companies and says it is involved in as many as 10% of medicines approved annually by the U.S. Food and Drug Administration. The company operates FDA-inspected sites in the U.S., Portugal, Ireland and China, with a fifth site expected to be commissioned in 2027. The East Windsor investment expands Hovione's domestic manufacturing base while reinforcing its strategy of combining specialized formulation technology with development and commercial-scale production, an increasingly important model as drugmakers seek fewer handoffs and more resilient supply options for complex medicines.

Contract Pharma
Sep 16th, 2026
Hovione doubles US spray-drying capacity with opening of New NJ facility.

Hovione doubles US spray-drying capacity with opening of New NJ facility. This closes a $100 million investment cycle, and creates approximately 80 new jobs. September 16, 2026 Content Marketing Editor Editor's Take: Spray-drying can help create amorphous solid dispersions that turn poorly soluble drug ingredients into more bioavailable forms. Hovione opened a new, 31,000-square-foot facility on Sept. 15, located at 89 Twin Rivers on its East Windsor, NJ campus. Contract Pharma previewed this ribbon-cutting in July, after having gotten to tour Hovione's expanded operations in spring 2026. The new facility adds two commercial-scale PSD-3 spray dryers, both good manufacturing practice (GMP)-ready. As such, it doubles Hovione's United States spray-drying capacity, reinforcing the CDMO's global leadership in this type of technology. Importance of spray-drying. Hovione says approximately 70% of small-molecule drug candidates show poor aqueous solubility. This limits bioavailability and slows development. Amorphous solid dispersions, like those created through Hovione's specialized spray-drying platform, can turn poorly soluble ingredients into more bioavailable forms. Co-CEOs Marco Gil and Antonio Almeida say the expansion is a next chapter after Hovione's two decades-plus in the U.S. "This investment enables us to meet growing demand while further reinforcing our global leadership in pharmaceutical spray drying," they said. "Equally important, this technology sits within an integrated offering that extends from drug substance through drug product. [This gives] customers a more direct and resilient path from early development to commercial. This is how we help them address poor solubility, one of the industry's most persistent development challenges." Hovione committed to NJ. David Basile, Hovione Vice President of Technical Operations, Americas, calls the facility a "clear expression" of a long-term commitment. "Our growth is built on sustained investment in scientific expertise, technological innovation, advanced manufacturing capabilities, and talented people," Basile said. "We will continue to strengthen this site as an innovation hub for pharmaceutical development and manufacturing. [This contributes] to the competitiveness of New Jersey's life sciences ecosystem and to a stronger U.S. manufacturing base." The facility opening completes a $100 million investment cycle, and will employ approximately 80 people. However, Hovione plans to continue growing its U.S. operations, including in East Windsor, over the next decade. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Drug, Chemical & Associated Technologies Association, Inc. (DCAT)
Sep 10th, 2026
Supplier news: AtomVie, CordenPharma, Hovione, Evonik & more.

Supplier news: AtomVie, CordenPharma, Hovione, Evonik & more. The latest from CDMOs, CMOs, and suppliers featuring AtomVie, CordenPharma, Northway Biotech, Hovione, Evonik and QPharma. Chemicals/Chemical API Manufacturing AtomVie Radiopharma Opens New $160-M Radiopharmaceutical Mfg Facility AtomVie Global Radiopharma, a CDMO focused on radiopharmaceuticals, has opened a new $160-million manufacturing facility in Hamilton, Ontario, Canada. The 72,300-square-foot facility features low-to-high throughput production and represents more than a tenfold increase in AtomVie's manufacturing capacity. The facility enables progression from early development to commercial manufacturing of radiopharmaceuticals, with customizable space dedicated to clients' future needs. Biologics Manufacturing Northway Biotech Opens $71-M Facility for Cell, Advanced Therapies Northway Biotech, a Vilnius, Lithuania-based CDMO focused on biologics, has opened a EUR 61-million ($71-million) cell therapy and personalized medicine center in Vilnius, Lithuania. The new 3,500-square-meter facility adds development and cGMP manufacturing capacity for advanced and personalized therapies. Northway Biotech's CDMO platform includes mammalian and microbial biologics, gene therapy, and cell-based technologies. Formulation Development/Drug Product Manufacturing CordenPharma Invests $93 M for Sterile Mfg Expansion CordenPharma in making a multi-year EUR 80-million ($93 million) investment for injectable drug products at is site in Caponago (Milan), Italy, with the EUR-13 million ($15 million) acquisition of a new 11,000-square-meter commercial building and 26,000 square meter of land, adjacent to its existing late-stage aseptic fill-finish manufacturing area. This expansion was finalized on July 28, 2026, increasing the site footprint by greater than 50%. The space can accommodate a minimum of four aseptic fill-finish lines, four visual inspection lines, and four additional packaging lines, with options for customer-owned lines, large-scale lyophilization, and auto-injector assembly. Secondly, over the past two years, CordenPharma has embarked on a series of strategic expansions at an existing operational area within its Caponago site that now contributes to the increased injectable capacity by adding two new aseptic fill-finish isolator lines. These include: * A clinical and small-scale commercial combo line from Bausch & Ströbel for prefilled syringes (PFS), vials, and cartridges. * A high-speed PFS and cartridge line from Syntegon, capable of producing >500,000 units per day. * Expansion of the automatic secondary packaging area for PFS, vials, and ampoules. * A doubling of analytical capacity to support growing project pipelines. Completion of the new isolator lines is targeted for mid-2027 and 2028, respectively. Appointments Hovione Names New CEO Hovione has announced the appointment of Stefan Doboczky, currently Chairman of the Board of Directors of Hovione, as Chief Executive Officer (CEO), effective April 1, 2027. Doboczky has served as Chairman of the Board of Directors of Hovione since 2024, where he has been instrumental in shaping the company's strategy and vision. He will step down as Chairman on assuming the role of CEO. The appointment marks a return to the pharmaceutical industry for Doboczky, who spent more than 17 years at Royal DSM, where he became a member of the Executive Board responsible for the group's global pharmaceutical portfolio and for its growth in Asia. He subsequently spent 11 years as CEO of listed, private-equity-owned and corporate-owned industrial companies, including Lenzing AG, Heubach GmbH, and Borealis AG. Following the combination of Borealis, Borouge, and Nova Chemicals into Borouge International, he took on the role of Chief Commercial Officer and Deputy Chairman of the Executive Board of the merged group. He will hand over these responsibilities to his successor on October 1, 2026, and remains available for six months to support the transition. Evonik Names Interim CEO Evonik has appointed Dr. Claus Rettig, currently the Head of Evonik's Asian business, as Interim CEO, taking over for Christian Kullmann, Evonik's current CEO, who is recovering in the upcoming weeks from a recent serious, unplanned surgery. Additionally, Rettig was appointed to Evonik's Executive Board, effective September 1, 2026, and has been appointed Deputy Chairman. Rettig has been with the company for more than 30 years and heads Evonik's Asian business as General Representative in Singapore. Until further notice, Rettig is taking over the duties of Kullmann and will continue his responsibility for Asia as member of the Executive Board. Sever Pharma Solutions Renames to QPharma Sever Pharma Solutions, a Malmö, Sweden-based CDMO specializing in polymer-based complex drug-delivery systems, sterile injectables, and high-potent processing, has changed its name to QPharma AB, effective September 1, 2026.