Vacature Business Controller

Over Polyganics
Polyganics is een medische technologie onderneming, in 1999 opgericht als een spin-off van de Rijksuniversiteit Groningen. Polyganics doet al meer dan 20 jaar onderzoek naar biologisch afbreekbare medische implantaten. Polyganics heeft hierbinnen internationaal een sterke positie verworven, met name door de succesvolle ontwikkeling en commercialisering van polymeerproducten met een toepassing in keel-, neus- en ooroperaties, perifere zenuw-reparaties en neurochirurgie. Deze producten worden wereldwijd verkocht. Polyganics heeft onlangs intrek genomen in een geheel nieuw, state-of-the-art bedrijfspand op de Zernike Campus en is daarmee klaar voor verder groei. Meer informatie kun je vinden op www.polyganics.com.

De functie:
Polyganics is op zoek naar versterking van de Finance afdeling. Als Business Controller word jij medeverantwoordelijk voor de financiële processen binnen de organisatie. Daarnaast ben je nauw betrokken bij de inrichting en het onderhoud van de IT-omgeving en bij de verantwoording van diverse subsidies. Je werkt direct samen met de Controller en hebt periodiek overleg met de CFO. Daarnaast heb je korte lijntjes met HR, operations, logistiek, projectmanagers en met business development en ben je in staat verbeterprocessen te signaleren en vorm te geven.

Jouw belangrijkste taken liggen op het vlak van:
– Financiële administratie (o.a. beheer grootboek, voorraadcontrole, beheer kostprijzen, verzorgen van diverse aangiftes)
– Projectadministratie (o.a. analyse actuals versus budget, verbeterpunten bespreken met projectmanagers en controller)
– Subsidie-administratie (o.a. periodieke voortgangsrapportages, administratieve verwerking en verantwoording conform regelgeving,  signaleren en implementeren van verbeteringen)
– Aansturen extern uitbesteed IT-onderhoud en beheer (o.a. coördineren IT-landschap, opzetten en beheren van IT-jaarplan inclusief budget, bewaking kwaliteit IT)

Jouw profiel:
– Een Bachelor’s degree in bedrijfseconomische richting/accounting
– Minimaal 5 jaar ervaring in een soortgelijke functie
– Goede beheersing van de Nederlandse en Engelse taal
– Vaardigheid in het gebruik van softwarepakketten, zoals SAP, urenregistratiesysteem, digitaal archiefsystemen, rapportagesoftware
– Affiniteit met inrichting en onderhoud IT-omgeving
– Analytisch sterk, communicatief vaardig op alle niveaus, kritisch en initiatiefrijk.
– Kennis van en ervaring met regionale, nationale en Europese subsidies wordt op prijs gesteld.

Interesse?

Neem contact op met Henne Barkema (HR) +31 (0)6 52 0616 35 / +31 (0)50 588 65 88.
Jouw sollicitatie kan je e-mailen naar hrm@polyganics.com.

Headhunters en (uitzend)bureaus verzoeken wij uitdrukkelijk niet te reageren op deze vacature.

Vacature Operator Verpakking

Ons bedrijf
Polyganics ontwikkelt, produceert en verkoopt wereldwijd biologisch afbreekbare medische producten. Onze producten worden gemaakt van bio-afbreekbare synthetische polymeren. Ze worden door het lichaam afgebroken, waardoor er na een operatie in een later stadium geen chirurgische ingreep meer nodig is om ze te verwijderen. Dat maakt onze producten zeer patiëntvriendelijk, veilig en kostenbesparend.

Wat houdt deze baan in?
De Operator is onderdeel van een team binnen de afdeling Operations.
Het team houdt zich bezig met het verpakken van medische producten. Voor het verpakken van die producten gelden speciale voorschriften. Een belangrijk deel van het werk wordt in een cleanroom uitgevoerd.

Jouw taken en verantwoordelijkheden zijn onder andere:

  • het verpakken producten
  • het labelen en voorzien van onder andere de juiste gebruiksaanwijzing
  • uitvoeren van eindcontroles op de verpakking.

Wie zoeken wij?
Een leuke, open collega die goed kan samenwerken in een team.
Je hebt:

  • ervaring als Operator bij een medical device of farmaceutische bedrijf
  • bij voorkeur ervaring met werken in een cleamroom

Je kunt zelfstandig werken, bent nauwkeurig en resultaatgericht.

Geïnteresseerd?
Wil je deel uitmaken van een dynamische organisatie waar ruimte is voor eigen initiatief en ontwikkeling? Dan nodigen wij je uit te solliciteren.
Mail je cv met korte motivatie voor 3 augustus a.s. naar hrm@polyganics.com.

Voor meer informatie kun je bellen met Henne Barkema (HR) 06 520 61 635 of 050 588 65 88.

Headhunters en (uitzend)bureaus verzoeken wij uitdrukkelijk niet te reageren op deze vacature.

Vacature Operator Verpakking 2021

Vacancy R&D Analytical chemical specialist

Our company
Polyganics is an innovative medical technology company. We develop, manufacture and commercialize worldwide, unique bioresorbable devices to facilitate tissue repair and regeneration after surgery. We aim to build highly innovative bioresorbable polymers and tailor these for different applications, improving surgical outcome and patient recovery.

The job
Within the R&D team, the R&D Analytical chemical specialist is responsible for robust analytical method development for biodegradable medical devices. More specifically, you will develop, optimize and validate analytical test methods for chemical characterization (extractable/leachable studies), analytical test methods for in vitro drug release, and develop process controls on both polymer and product level, including stability studies. In this role, you will have the responsibility to develop alternative analytical methods that are usually not found in the standard lab.
As we are a medical device company, this includes collecting and recording data and writing reliable reports in line with our quality system requirements. You will be involved in the initiation of technological innovation and will remain connected throughout the full development and product life cycle.

Your profile
We are looking for a self-starter and a team player who will thrive in an entrepreneurial and technology-driven business environment with:
– a BSc degree in analytical chemistry or equivalent education
– at least 3-5 years of work experience in the pharmaceutical or medical device industry
– experience with analytical test methods in line with ICH/FDA guidelines is an asset
– a fast understanding of GMP and other regulatory requirements
– knowledge of statistical analyses and data trending
– experience with a broad range of analytical techniques (GC-MS, LC-MS, SEC)
– skills and ability to assess, plan, manage, and evaluate the analytical aspects of R&D projects
– the ability to make recommendations based on a clear scientific rationale
– excellent problem-solving aptitude, communication, and multitasking skills, good organizational skills and high attention to detail.

Our offer
We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself.
Polyganics has a professional but informal working environment, a pleasant work atmosphere and almost 70 enthusiastic colleagues. We offer a competitive salary and excellent secondary benefits.

Would you like more information?
Please contact Mrs. Henne Barkema (HR) +31 (0)6 52 0616 35 / +31 (0)50 588 65 88.
You can send your application (before the 3rd of August 2021) to hrm@polyganics.com.

Headhunters and recruiters need not apply.

Vacancy Analytical Chemist RD

Vacature Technician – Operator

Ons bedrijf
Polyganics ontwikkelt, produceert en verkoopt wereldwijd biologisch afbreekbare medische producten. Onze producten worden gemaakt van bio-afbreekbare synthetische polymeren. Ze worden door het lichaam afgebroken, waardoor er na een operatie in een later stadium geen chirurgische ingreep meer nodig is om ze te verwijderen. Dat maakt onze producten zeer patiëntvriendelijk, veilig en kostenbesparend.

Wat houdt deze baan in?
De Technician – Operator is onderdeel van een team binnen de afdeling Operations. Het team houdt zich bezig met het produceren van medische producten, het uitvoeren van analyses en het maken van karakteriseringen.
Daarnaast werken de Technicians mee aan het ontwikkelen, vervaardigen en verpakken van de producten.

Jouw taken en verantwoordelijkheden zijn onder andere:
* het maken van producten
* het voorbereiden en uitvoeren van chemische analyses, onderzoeken en testen van medische producten volgens ons ISO 13485 kwaliteitssysteem
* uitvoeren van eindcontroles op producten

Wie zoeken wij?
Een leuke, open collega die goed kan samenwerken in een team.
Je hebt:
* een afgeronde MBO opleiding op biomedisch, laboratorium of chemisch gebied met belangstelling voor (biomedische) polymeren
* bij voorkeur enige kennis van standaarden en normen voor productontwikkeling van medische producten (ISO 13485-, MDD- en FDA-  richtlijnen)
* goede schriftelijke en mondelinge uitdrukkingsvaardigheid.
* Je kunt zelfstandig werken, bent nauwkeurig en resultaatgericht.

Geïnteresseerd?
Wil je deel uitmaken van een dynamische organisatie waar ruimte is voor eigen initiatief en ontwikkeling? Dan nodigen wij je uit te solliciteren.
Mail je cv met korte motivatie voor 20 juli a.s. naar hrm@polyganics.com.
Voor meer informatie kun je bellen met Henne Barkema (HR) 06 520 61 635 of 050 588 65 88.

Headhunters en (uitzend)bureaus verzoeken wij uitdrukkelijk niet te reageren op deze vacature.

Vacature Technician Operator Polymeer 2021

Projectmanager Product development

Our company
Polyganics is an innovative, privately-held medical technology company bringing to market unique bioresorbable devices to facilitate tissue repair and regeneration after surgery. From its current ISO13485-certified manufacturing facility, products are distributed to customers worldwide. Polyganics moved to a new facility at the Zernike Campus, Groningen, which houses its offices, state-of-the-art research laboratories and expanded manufacturing and packaging facilities.

The job
Polyganics is looking for a Projectmanager product development. In this job, you will lead a cross-functional team, responsible for the development of new products or product-optimizations.

As lead of this team, you will be coordinating the project-activities, in line with the agreed timelines and budget. This includes decisions on design, process, test methods, submission and related aspects. You will provide regular written reports/updates of the projects progress to management and stakeholders.

You will report to the Director R&PD and closely collaborate with colleague’s within operations, quality assurance, regulatory affairs, clinical research and business development.

Your profile
– BSc/MSc degree in chemistry/chemical engineering/bio-medical engineering or equivalent
– Ability to lead a team and plan activities
– Knowledge of bioresorbable polymers
– At least 10-year work experience in the medical device or pharmaceutical industry
– Solid interpersonal skills
– Analytical skills and able to proactively identify and solve increasingly complex problems
– Ability to set priorities within a changing environment
– Excellent verbal and writing communication skills, both in Dutch and English.

Our offer
We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself. Polyganics has a professional but informal working environment and a pleasant work atmosphere. We offer a competitive salary and good secondary benefits.

More information?
Please contact Mr. Bart Jan Korteling +31 (0)50 588 6588 or Mrs. Henne Barkema (HR) +31 (0)6 52 0616 35.
Please send your application to hrm@polyganics.com.

*Recruiters and headhunters need not apply*

VACANCY Projectmanager Product Development_

First Patient Treated in Polyganics’ ENCASE II Trial for Innovative Dura Sealant Patch, LIQOSEAL

Randomized controlled trial in the US and Europe will enable LIQOSEAL to be submitted for FDA approval

Groningen, The Netherlands, May 21 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced treatment of the first patient in its ENCASE II clinical trial for LIQOSEAL.

LIQOSEAL is an easy-to-use, synthetic dura sealant patch indicated for use as an adjunct to standard methods of cranial dural repair, to provide watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) leakage. In addition, LIQOSEAL also supports regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’).

ENCASE II is randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing intra- or post-operative CSF leakage in patients undergoing elective cranial surgery. The trial will involve 228 patients, enrolled and treated at up to 20 clinical centres across the US and Europe. Patients will be randomly treated at a 1:1 ratio with either LIQOSEAL or an FDA-approved sealant as a control.

Polyganics achieved CE mark certification for LIQOSEAL in early 2020, based on positive 3-month data from its ENCASE I clinical trial, and immediately launched the device in Europe. The Company has seen good uptake, and now, just over a year after the initial launch, LIQOSEAL is commercially available throughout Europe via a dedicated network of distribution partners and is registered for use in other countries including Turkey, Israel, Jordan, Argentina. Other registrations are also in progress.

Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, New Mexico, and Global Coordinating Investigator for the study commented: “Cerebrospinal fluid leakage is one of the most common complications of neurosurgical procedures and a significant burden to patients and healthcare systems. LIQOSEAL is a potentially game-changing device, which may offer a unique opportunity to make a meaningful impact on the lives of patients by reducing these CSF leak rates. I am excited to be part of the ENCASE II study where we are rigorously testing this hypothesis.”

Prof. Dr. Med. Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, and Coordinating Investigator for the study in Europe said: “Having worked on the LIQOSEAL project since inception, I am proud that the device is now entering this large-scale ENCASE II clinical trial. I was delighted with the follow-up results of ENCASE I, showing that there was no CSF leakage and no clinically significant swelling, while there were no device-related adverse events following the first 40 LIQOSEAL surgeries. I am pleased to continue playing my part to critically study this device, ultimately to maximally reduce CSF leakage in our patients.”

Rudy Mareel, CEO of Polyganics, added: “Despite many COVID-related delays to elective procedures during the past year, we are happy that Polyganics has seen strong interest and uptake of LIQOSEAL throughout Europe and in other countries. We are proud to have numerous world-renowned clinical centres participating in our ENCASE II study. They are a testament to the unique, life-altering potential of our dura sealant device.”

– ENDS –

 

For more information please contact:

Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com

 

Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com

 

Notes to editors

 

About Polyganics

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.

Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. The portfolio includes marketed products in the fields of Peripheral Nerve Repair (PNR) and Neurosurgery: VIVOSORB®, for minimizing unwanted tissue adhesions after surgery; NEUROLAC®, for supporting PNR following hand surgery; NEUROCAP®, for the management of symptomatic neuromas; and LIQOSEAL®, a dura sealant patch for the effective control of cerebrospinal fluid leakage. Products in development include ACTISEAL®, a Liver and Pancreas Sealant Patch in the field of General Surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE® and NASOPORE-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker.

Polyganics is a privately held company based in Groningen, The Netherlands. The Company is ISO 13485-certified, and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.

For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV

 

About CSF leakage

Cerebrospinal fluid (CSF) leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4

 

About LIQOSEAL

LIQOSEAL® is a safe and easy-to-use patch indicated for use as an adjunct to standard methods of cranial dural repair during surgery. By ensuring watertight closure of the dura mater, the patch provides effective control of CSF leakage throughout the critical healing period, as well as supporting regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’). The patch uses Polyganics’ proven proprietary synthetic bioresorbable polymer technology. It is commercially available throughout Europe and in selected other countries via a network of experienced distributors.

For more information, visit: https://polyganics.com/portfolio/neurosurgery/

 

References

  1. Hutter G, von Felten S, Sailer M, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece bound tissue sealing against dural suturing alone: a randomized controlled trial. Neurosurgery. 2014. Sep; 121:724-744
  2. Grotenhuis J. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005, Dec; 64(6)|:490-3
  3. Kinaci A, Algra A, Heuts S, O’Donnell D, van der Zwan A, van Doormaal T. Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review. World Neurosurg. 2018 Oct;118:368-376
  4. van Doormaal T, Kinaci A, van Thoor S, Redegeld S, Bergmann W, van der Zwan A.Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model. Oper Neurosurg (Hagerstown). 2018 Oct 1;15(4):425-432.

Polyganics Opens New State-of-the-Art Facility to Drive Growth

Groningen, The Netherlands, 20 April 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announces its move to a state-of-the art, purpose-built facility on the Zernike Campus, Groningen. The new building will house Polyganics’ research laboratories, manufacturing and packaging facilities, and its offices.

The expansion is essential to accommodate Polyganics’ growing workforce and enable the Company to respond to the increasing demand for its commercial and pipeline products. This includes its own portfolios in PNR (Peripheral Nerve Repair), and Neurosurgery, with LIQOSEAL® gaining commercial traction in Europe, as well as the Stryker-owned NASOPORE® portfolio for ENT (Ear, Nose and Throat) surgery. In the near future, it will also include Polyganics’ new Liver and Pancreas sealant patch, ACTISEAL®, which is currently in clinical trials with first patients treated in Q3 2020.

Polyganics is committed to quality, safety, and sustainability in the development, manufacturing and commercialization of its medical devices, and the Company is determined to operate responsibly to improve environmental sustainability. These values have guided the design and construction of its new facility. Numerous measures have been taken to reduce and optimise energy use, minimize the use of water and enhance safety. For example, more than 600 solar panels have been installed, providing a renewable, clean energy source.

Rudy Mareel, CEO of Polyganics, said: We are happy to be moving into our new facility on schedule, just one year after we broke ground. The new building provides increased manufacturing capacity and space for up to 140 employees, to enable us to meet growing demand. Our lab facilities will be doubled in size, and our manufacturing facilities tripled. We are also delighted to be remaining in Groningen, with our established network of local partners and access to a high-quality talent pool. We look forward to joining the vibrant Zernike Campus, with the further collaborative opportunities this will afford.”

Jan Disbergen, COO of Polyganics added: “On behalf of the Company, I would like to thank the partners that have supported the development of our new facility and helped kickstart the next phase in Polyganics’ evolution. Particular thanks go to the City and the Province of Groningen which awarded us a RIG subsidy. The new building has further increased our focus on the environment and the health and safety of our employees. I would also like to extend my personal thanks to the construction, installation and equipment companies that have played an integral role in this journey.”

Edward van der Meer, Director of Campus Groningen, remarked: “We warmly welcome Polyganics to Campus Groningen, known as Northern Netherland’s Capital of innovation. Polyganics encompasses the collaborative spirit that resides here, where entrepreneurs, researchers and clinicians unite to pursue groundbreaking projects that have a tangible social and economic impact locally and worldwide. With a history of excellence in polymers, Groningen is a fitting home for industry leader, Polyganics and we are confident the Company will bring tremendous value to the campus.”

– ENDS –

For more information please contact:

 

Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com

Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com

Notes to editors

About Polyganics

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.

Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. The portfolio includes marketed products in the fields of Peripheral Nerve Repair (PNR) and Neurosurgery: VIVOSORB®, for minimizing unwanted tissue adhesions after surgery; NEUROLAC®, for supporting PNR following hand surgery; NEUROCAP®, for the management of symptomatic neuromas; and LIQOSEAL®, a dura sealant patch for the effective control of cerebrospinal fluid leakage. Products in development include ACTISEAL®, a Liver and Pancreas Sealant Patch in the field of General Surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE® and NASOPORE-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker.

Polyganics is a privately held company based in Groningen, The Netherlands. The Company is ISO 13485-certified and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.

For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV