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Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Finance Finance Officer Full-time Leiden Business Controller Full-time Leiden Business Analyst Full-time Leiden R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Human Resources HR Business Partner Full-time Leiden Bijgekomen; geen Afgenomen: Quality Systems Specialist Full-time Leiden Aantal openstaand: 13 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 25 Afgenomen 23
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Finance Finance Officer Full-time Leiden Business Controller Full-time Leiden Business Analyst Full-time Leiden R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Bijgekomen; geen Afgenomen: Human Resources HR Business Partner Full-time Leiden Aantal openstaand: 12 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 25 Afgenomen 24
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Director of Commercial Analytics Full-time USA Finance Finance Officer Full-time Leiden Business Controller Full-time Leiden Business Analyst Full-time Leiden R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Bijgekomen; Director of Commercial Analytics Full-time USA Afgenomen: Aantal openstaand: 13 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 26 Afgenomen 24
Director of Commercial Analytics Full-time USA The Director of Commercial Analytics transforms business goals into measurable KPI’s, leveraging analysis and insights to increase revenue through optimization of Commercial Model design, Field force sizing and structure, and multichannel/digital marketing activities. This position partners closely with our Sales, Marketing, Managed Markets, Finance, and Medical Affairs team. Areas of responsibilities: Lead cross-functional teams to implement analytical solutions for Sales, Marketing, and Managed Markets Organization Develop/Maintain CRM strategy and manage vendor partnerships Utilize insights to frame business issues, gain buy-in, and design the right solution to deliver results. Maintain incentive compensation plans, including design, implementation, and tracking of the metrics. Use anonymized patient level data to provide therapy insights Provide Market Access Analytics incl. pull-through analysis, Payer-plan segmentation, Rebate optimization, etc. Manage multiple concurrent projects ensuring exceptional client satisfaction and on-time delivery. Maintain data warehouse (setting data feeds across vendors, maintaining business rules, enforcing data integrity) Develop and maintain/modify field reports to support field efforts as well as marketing programs. Work closely with internal stake holders to ensure ongoing refinement of our analytical tools and development of new client solutions. Make presentations and recommendations to clients on optimal customer, sales and marketing strategies and tactics. Provide support for Commercial Model Design, Sales Force Sizing and Structure, including territory alignments. Required skills and qualifications in order to be successful in this role: Advanced analytics and problem analysis. Attention to detail with strong commitment to data/information integrity Comfortable managing CRM, including specifying enhancements, and providing/managing requirements to support the business Strategic business acumen Intellectual curiosity (being up to date with technology trends) Highly collaborative work style with the ability to influence cross-functional teams to impact decision-making Excellent communication skills with the ability to communicate actionable analytical findings to a non-technical audience in clear and concise language. Knowledge: Bachelor’s in Engineering, Computer Science, Social Science, or a related field of prior relevant work experience. Graduate degree is preferred. Relevant expertise using analytic tools such as Excel (VBA), R, SAS, SPSS, SQL, Python, Tableau, Alteryx, and with ability to quickly master new platforms when needed. Knowledge of leading marketing technology, advanced analytics, and visualization platforms, such as Salesforce Marketing Cloud, Tableau, QlikView Experience: 5+ years of experience in the Pharmaceutical industry including experience in Sales Ops 8+ years of Analytics experience Familiarity/expertise in using Pharmaceutical data sets
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Director of Commercial Analytics Full-time USA Finance Finance Officer Full-time Leiden Business Controller Full-time Leiden Business Analyst Full-time Leiden R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Medical Writer Full-time Leiden Afgenomen: Aantal openstaand: 14 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 27 Afgenomen 24
Medical Writer Full-time Leiden About the role: In collaboration with colleagues of the Regulatory Affairs, Medical Affairs, Clinical, non-Clinical, and Pharmacovigilance departments, the Medical Writer creates/compiles documents that are required for regulatory submissions to Competent Authorities, based on scientific knowledge and applicable ICH, clinical, and (local) regulatory guidance and legislation. Areas of responsibilities: Compile, write, and edit medical writing deliverables for submission to regulatory agencies such as FDA and EMA, covering all phases of clinical research and post-approval medical activities Serve as the medical writing representative on assigned project teams and support Pharming departments in the creation/writing of documents Stay up to date with the relevant scientific literature relevant for the Pharming product portfolio Champion the Pharming Style Guide and ensure document consistency throughout the company Write scientific documents for a broader audience, including scientific liaisons, healthcare professionals, and pharmaceutical representatives; review promotional material Participate in review of clinical study data Assist in the development of publications, abstracts, and presentations Required skills and qualifications in order to be successful in this role: Take responsibility and show ownership Accuracy & attention to detail Excellent writing skills (ability to process complex scientific/medical information) A structured approach, able to plan and organize, and set priorities The ability to work independently and be proactive Collaborative and good communication skills; enjoy working in a multidisciplinary team Results-oriented Stress resistant, resilient, and flexible Knowledge: MSc. or PhD (strongly preferred) in (Bio)pharmaceutical Sciences, Biomedical Sciences, Biotechnology, Medical Biology, or Medicine Thorough understanding of applicable FDA, EMA and ICH regulations and guidelines Proficiency in Word GCP knowledge Extensive knowledge of English grammar & excellent English writing skills Experience: At least 3 years of relevant experience in a medical writing or similar role preferably in a Biotechnology or Pharmaceutical company Experience in writing/compiling medical documents for regulatory submissions such as clinical study protocols and clinical study reports, Investigator’s Brochures, Clinical Overviews (M 2.5) and Clinical Summaries (M 2.7)
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Director of Commercial Analytics Full-time USA Marketing Director Full-time USA Finance Finance Officer Full-time Leiden Business Controller Full-time Leiden Business Analyst Full-time Leiden R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Marketing Director Full-time USA Afgenomen: Aantal openstaand: 15 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 28 Afgenomen 24
Marketing Director Full-time · USA About the role: The Director of Marketing significantly contributes to the development of Leniolisb strategies and tactics for annual business planning & launch excellence. This individual will work within the commercial team and collaboratively with the cross functional partners. The Director leads in the development of high-quality materials and programs that differentiates Leniolisb for launch and from the competition. These projects will cross both HCP and consumer marketing and require experience in digital marketing, social media marketing and the potential use of A.I. At times this person will be the key lead on projects that often require matrix alignment with global, regional, and local colleagues. Areas of responsibilities: Fuels Leniolisb growth by understanding and acting upon key customer insights through analysis of market data and market research Co-develops marketing strategies, tactics, and messaging to optimize Leniolisb benefits and to differentiate it from competitors Leads in the development of personal and non-personal programs that increases patient engagement and activation Partners with legal, medical, market access, sales, and regulatory for the development of optimal materials and programs Leads in the development of materials and training for speaker programs and ensures successful execution Identifies the optimal content and mix for digital and social marketing Manages multiple vendors to ensure the successful implementation of marketing tactics within the approved budget Required skills and qualifications in order to be successful in this role: Strong collaborative, strategic and tactical marketing skills required Self awareness Planning, process and results oriented Strong business acumen with the ability to take appropriate action from key insights Strong leadership skills Excellent communicator and influencer Integrity Experience: 6-8 years of pharmaceutical marketing experience Experience in specialty pharmaceutical/rare disease is essential Experience with product launch Knowledge: BSc. of Science degree in combination with a post-graduate business/marketing degree Additional training in marketing and sales Demonstrated skills in consumer marketing, digital, and social media Demonstrated consumer marketing skills Experience with eTMF system preferred
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Director of Commercial Analytics Full-time USA Marketing Director Full-time USA Finance Finance Officer Full-time Leiden Financial Accountant Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Financial Accountant Full-time Leiden Clinical Trial Assistant Full-time Warren, New Jersey USA Afgenomen: Business Controller Full-time Leiden Business Analyst Full-time Leiden Aantal openstaand: 15 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 30 Afgenomen 26
Financial Accountant Full-time Leiden About the role: The Financial Accountant improves and maintains the financial consolidation, the global transfer pricing system, the periodic reporting to governmental agencies, and advising the internal organisation on IFRS accounting and reporting. He /she partners with Financial Administration, Business Control and external Auditors and Advisors. Areas of responsibility: Periodic consolidating the financial reports of Pharming Group N.V. and its subsidiaries. Maintenance of transfer pricing system including yearly updates of master and local transfer pricing reports. Preparation of periodic reporting to governmental bodies. Contribute to the preparation of the Annual Report, IFRS Financial Statements and other related matters such as press releases. Contribute to the preparation of position papers for accounting matters and valuation. Internal subject matter expert on IFRS Required skills and qualifications in order to be successful in this role: Strong networking and stakeholder management skills Accuracy Sensitivity Strong problem analysis skills Able to plan and organize effectively Knowledge: Master degree, preferably in Auditing, Accounting or in a comparable study. Ideally in combination with professional qualification (ACA, ACCA, RA) Strong accounting and consolidation skills Strong data analysis skills Advanced Excel skills Strong knowledge of IFRS Experience: 5 years of experience in Financial Accounting Working experience with a Big Four Audit Firm
Clinical Trial Assistant Full-time Warren, New Jersey USA About Pharming: Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Clinical Trial Assistant for our office in New Jersey. About the role: The CTA provides general administrative support to the Clinical Operations Department and assistance to Project Manager(s), Clinical Project Coordinator(s) and Department Manager/Director(s) on the various tasks associated with conducting clinical trials. The CTA is responsible for all administrative tasks and assisting the project team in the start-up, execution, and closeout of the trial. Areas of responsibilities: Set-up, organize, and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival Collaborates in the development of study documents and reports, including final quality check, editing, and linking of references, to ensure proper formatting and accuracy of the content Contact clinical sites for specific requests Provides scheduled and ad-hoc reports to provide status on study progress Collect, review and track documents for CA/RA and EC/IRB submissions to confirm the applications are complete before submission and track submissions and approvals for accurate filing in the TMF Prepare, ship and manage inventory of study related materials and supplies or coordinate the activities with the vendors, as applicable (e.g. CRFs, diary cards, ISF binders, etc.) Liaise with applicable vendor and clinical trial sites to coordinate lab supply shipments, blood sample shipment from sites to the central lab, study medication shipment, etc. Review Investigator/Site invoices and reconcile against the case report forms (CRFs) and budget to ensure to ensure invoices are accurate and processed under the correct billing codes Collaborate with the legal department to coordinate the review and finalization of site, vendor, and consultant contracts, and ensure invoices are processed correctly Schedule, organize and attend internal and external project team meetings Assist with the organization of international meetings Required skills and qualifications in order to be successful in this role: Highly organized and detail oriented Effective communication Strategic planning and time management Flexible Resourceful Teamplayer Experience: Minimum of 2 years of relevant experience in a clinical research environment Knowledge: Proficient in MS- Word, Excel and PowerPoint Possess a general understanding of clinical trial and drug development process, strong attention to detail, and meticulous follow-through Knowledge of applicable regulatory guidelines (i.e. ICH and GCP) is strongly preferred Experience with eTMF system preferred
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Marketing Senior Director Market Access Full-time Leiden Director of Commercial Analytics Full-time USA Marketing Director Full-time USA Finance Finance Officer Full-time Leiden Financial Accountant Full-time Leiden Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Financial Reporting Manager Full-time Leiden Afgenomen: Aantal openstaand: 16 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 31 Afgenomen 26
Financial Reporting Manager Full-time Leiden Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Financial Reporting Manager for our HQ in Leiden. About the role: The Financial Reporting Manager is responsible for managing the external financial reporting process. He/she collaborates with the accounting department and other departments to ensure effective financial reporting and compliance with all financial regulations and procedures. This also involves training Senior Management and other stakeholders about financial compliance. Areas of responsibilities: The Financial Reporting Manager runs the entire process of preparing financial reports and earnings statements by gathering and documenting data and preparing or reviewing reports for regulatory compliance (SEC, AFM, RvJ). Standardize and improve the reporting process Monitor and maintain SEC/AFM reporting calendar and inform parties of necessary deadlines Prepare the quarterly earnings press release Prepare and review all quarterly and annual statements and filings and manage the internal and external review for these documents. Monitor and ensure timely identification and compliance with evolving accounting guidance, provide IFRS interpretation and prepare technical memorandums that document issues in a clear, logical and comprehensive manner Manage communications with external auditors on external financial statements Assist in the coordination of review activities of external auditors Implement and maintain reporting procedures to comply with internal control requirements To ensure regulatory compliance, the Financial Reporting Manager occasionally oversees the accounting department, making sure that they are aware of and following all up-to-date policies and procedures. The Financial Reporting Manager is responsible for working with the accounting department to resolve any reporting errors or discrepancies. Required skills and qualifications in order to be successful in this role: Strong problem analyses skills Organizational sensitivity A structured and disciplined work ethic, able to plan and organize, and set priorities The ability to work independently and be proactive Results-oriented Stress resistant, resilient, and flexible Knowledge: MSc. degree in accounting CPA/RA qualification An excellent knowledge of IFRS and US and Dutch reporting rules and regulations is required combined with the ability to research and propose company positions on complex accounting issues Ability to work in a fast-paced environment and manage well through ambiguity and complexity Ability to execute and follow-through to completion and documentation Experience: At least 4 years of experience with a Big 4 audit firm, with heavy exposure to SEC and financial reporting. Alternatively minimal 4 years of experience in a similar role in a multinational company. Pharma/Biotech industry experience is beneficial
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Marketing Senior Director Market Access Full-time Flexible Europe Director of Commercial Analytics Full-time USA Marketing Director Full-time USA Finance Finance Officer Full-time Leiden Financial Accountant Full-time Leiden Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Afgenomen: Aantal openstaand: 19 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 34 Afgenomen 26
Senior Biotechnician Full-time · Oss Wil je graag een belangrijke rol spelen in het transformeren van de toekomst van onze patienten? Wil je bijdragen aan het ontwikkelen en het op de markt brengen van medicijnen? Ben je gewend om te werken met veiligheids- en kwaliteitssystemen en heb je een goed oog voor dierenwelzijn? Dan is Pharming wellicht interessant voor jou! Binnen Pharming zoeken wij een Senior Biotechnician die met ons mee wil groeien en die energie krijgt van het met elkaar opzetten van een R&D -afdeling. Over de rol: Als Senior Biotechnician speel je een belangrijke proactieve en verbindende rol binnen het team en coach je medewerkers. Als senior ben je kritisch op het proces en stel je verbeterplannen voor. Daarnaast ben je verantwoordelijk voor de training van (nieuwe) medewerkers. Uiteraard werk je ook mee in de dierfaciliteit, denk hierbij aan werkzaamheden als dierverzorging en fok- en gezondheidsmonitoring van de dieren. Functie-eisen: Afgeronde opleiding MBO-Paraveterinair & Biotechniek, MBO-Proefdierverzorging of vergelijkbare opleiding. Meerdere jaren ervaring als Biotechnician In bezit van Artikel 12 van de Wet op de Dierproeven of artikel 13F WOD Goede beheersing van de Nederlandse en Engelse taal in woord en geschrift Vaardigheden: Een motiverende teamplayer die ook goed zelfstandig kan werken Sterke contactuele eigenschappen en een service gerichte instelling Grote mate van verantwoordelijkheidsgevoel en eigenaarschap
Animal Caretaker Full-time · Eindhoven Wil je graag een belangrijke rol spelen in het transformeren van de toekomst van onze patienten? Wil je bijdragen in het ontwikkelen en het op de markt brengen van medicijnen? Heb je een goed oog voor dierenwelzijn? Dan is Pharming wellicht interessant voor jou! Over de rol: Binnen Pharming zoeken wij een proactieve en enthousiaste Animal Care Taker ter aanvulling van ons team. Samen met het team ben je verantwoordelijk voor een juiste verzorging, voeding en observatie van de dieren. Je begeleidt de dieren in de gehele levenscyclus. Naast praktische verzorgingstaken voer je ook eenvoudige biotechnische handelingen uit. Aangezien de dieren elke dag verzorgd moeten worden, wordt in deze rol van je verwacht dat je 1 x per maand een weekenddienst draait. Taken en verantwoordelijkheden: Het dagelijks schoonhouden van dierverblijven Het observeren van de dieren Het verrichten van eenvoudige biotechnische handelingen Het verzorgen van eten en drinken voor de dieren Administratieve werkzaamheden Functie-eisen: Minimaal een afgeronde MBO-opleiding dierverzorging Bereidheid weekenddiensten te draaien In het bezit van een kwalificatie conform art.12 WOD of Art 13F WOD is een pre maar niet noodzakelijk Vaardigheden: Goede beheersing van de Nederlandse taal in woord en geschrift Een teamplayer die ook goed zelfstandig kan werken Nauwkeurig en precies Stressbestendig
Biotechnician Full-time · Eindhoven Ben jij een biotechnicus die het leuk vindt om dieren te verzorgen en verschillende biotechnische handelingen uit te voeren? Ben je gewend om te werken met veiligheids- en kwaliteitssystemen en heb je een goed oog voor dierenwelzijn? Dan is Pharming wellicht interessant voor jou! Over de rol Als Biotechnicus binnen Pharming draag je namelijk bij aan een breed scala aan werkzaamheden binnen de dierfaciliteit. Dit houdt in dat je o.a. de dagelijkse en terugkerende werkzaamheden zoals verzorging, fok en gezondheidsmonitoring van de dieren verzorgd. Aangezien de dieren elke dag verzorgd moeten worden, wordt in deze rol van je verwacht dat je 1 x per maand een weekenddienst draait. Daarnaast ben je ook verantwoordelijk voor de schoonmaak, data rapportage en diverse bijkomende administratieve werkzaamheden. Een erg belangrijk aspect is het uitvoeren van de werkzaamheden met oog op dierenwelzijn en conform veiligheids-, en kwaliteitssystemen. Er is een mogelijkheid om door te groeien naar Sr. Biotechnicus Taken en verantwoordelijkheden: Het dagelijks schoonhouden van dierverblijven Het observeren van de dieren Het verrichten van eenvoudige biotechnische handelingen Het verzorgen van eten en drinken voor de dieren Administratieve werkzaamheden Functie-eisen: Afgeronde opleiding MBO-Paraveterinair & Biotechniek, MBO-Proefdierverzorging of vergelijkbare opleiding, In bezit van Artikel 12 van de Wet op de Dierproeven of artikel 13f WOD, Goede beheersing van de Nederlandse taal (mondeling en in geschrift),Vaardigheden: Goede beheersing van de Nederlandse taal in woord en geschrift Basis kennis van de Engelse taal (mondeling en in geschrift). Een teamplayer die ook goed zelfstandig kan werken Enthousiast, aanpakker, accuraat, kwaliteitsgericht, verantwoordelijkheidsgevoel en een teamplayer. Stressbestendig
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Marketing Senior Director Market Access Full-time Flexible Europe Director of Commercial Analytics Full-time USA Marketing Director Full-time USA Finance Finance Officer Full-time Leiden Financial Accountant Full-time Leiden Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Supply Chain Logistics Specialist Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Bijgekomen; Quality Specialist Full-time Leiden (Sr) Director Manufacturing, Science & Technology Full-time Leiden Afgenomen: Aantal openstaand: 21 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 36 Afgenomen 26
Quality Specialist Full-time · Leiden Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Quality Specialist. About the role: The Quality Specialist builds and maintains part of the Quality Management System to ensure that the quality system at Pharming (including Pharming’s external partners and contractors) is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He/she advises employees and managers regarding GMP compliance and leads QA-related projects. Areas of responsibilities: Build and maintain parts of the Quality Management System. Write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines relevant for a QMS. Identify documents which need to be created or updated and ensure this is organized. Write and review such as quality agreements and ensure timely approvals. Performing and reviewing internal and external audits, as (lead) auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). Act as trainer, coach, and expert regarding compliancy with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. Give general GMP training to Pharming colleagues. Represents QA Systems in significant complex projects and identifies compliance risks and ensure these are addressed adequately. Lead substantial QA-related projects to a success. Communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation, and complex projects. Proactively propose ideas for improvements; and provide subject matter expert reports as required. Required skills and qualifications in order to be successful in this role: Initiative Persuasiveness Organizational sensitivity Problem analysis Oral and written communication Teamwork Decisiveness Leadership Knowledge: Bachelors or University degree biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent Extensive knowledge of GMP regulations for EU and US (GMP, GLP and GDP). Preferably knowledge and experience with ERP (e.g. SAP) and e-DMS (e.g. Master Control) systems Preferably knowledge and experience of Project management Experience: Minimum six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance. Minimum four years of experience with GMP regulations for EU and US (GMP, GLP and GDP).
Sr.) Director Manufacturing, Science & Technology Full-time · Leiden About Pharming: Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a (Sr.) Director Manufacturing, Science & Technology. About the role: The (Sr) Director Manufacturing Sciences & Technology (MS&T) leads the MS&T department to execute adequate process and analytical transfer, validation, continuous process performance and life cycle management to ensure that our manufacturing and analytical processes fit the commercial needs. He/she oversees that Drug Substance (DS) and Drug Product (DP) are manufactured through our CMO/CLO (Contract Manufacturing/Laboratory Organization) partners and our own internal DSP facility including QC lab (future) and supervises the CMOs during commercial production. Areas of responsibilities: Lead the group that: Executes the transition of development (manufacturing) processes from pilot scale through commercial production, including validation activities, CMO/CLO issue resolution (deviations/CAPAs) and changes during transfer Executes the transition of analytical assays from a development - environment to a QC (GMP) environment including tech transfer, validation and assay trending. Oversees the commercial production at the CMOs, including CMO issue resolution (deviations/CAPAs), changes and support of audits Provides support to QC for trouble shooting (internally and at CLOs) Identify opportunities for and provide technical leadership to improve manufacturing processes and quality testing to increase efficiency and robustness. Ensure adequate product and process life cycle management. Chair and lead complex cross-functional discussions and present technical or scientific topics to (non-technical) stakeholders. Review/approve documents to support regulatory submissions to maintain and/or apply for marketing authorizations. Enhance process and analytical knowledge (Quality by Design). Review CMC (manufacturing and analytical) dossier during business development opportunities and provide input on feasibility (due diligence) Translate company targets for DS and DP production into manufacturing and analytical strategy Ensure sufficient MS&T resources to execute development programs lead by the Program Management Organization and multidisciplinary/departmental projects Prepare MS&T departmental budget and ensure that activities are executed aligned with approved budget Represent MS&T in companywide/multidisciplinary projects Keep up to date with new technologies and developments relevant to biotech/pharma industry Required skills and qualifications in order to be successful in this role: Leadership: encourages others to act and ensures that employees understand how their results affect the rest of the organization. Strives towards a high level of performance Problem analysis: connects different aspects of information to gain insight, questions (perceived) certainties to come up with solutions with the team Teamwork: actively contributes to a common result or problem solving, also when this exceeds the boundaries of the MST team Decisiveness: makes timely decisions, even if all information is not available, considering the consequences (risk-based approach) Creativity: searches for innovation and comes up with original ideas Persuasiveness: conveys his/her point in an impactful manner and achieves a positive result with a difficult proposition. States the common interest Oral and written communication: separating main issues from secondary issues and sharing information in a logical Knowledge: Master's degree or PhD (preferred) e.g. (Chemical) Engineering, (Bio)Pharmaceutical Sciences, (Bio)Chemistry, Life Science & Technology, Biology Sound knowledge and understanding of pharmaceutical development, validation, and commercial production (biologics, small molecule, manufacturing as well as analytical), documentation requirements, systems and equipment Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH) Excellent verbal and technical writing skills both in English and Dutch (French is an advantage) Experience: Minimal 15 years of relevant working experience in the pharma/biotech industry and minimal 10 years managerial experience (partly in production)
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