careers

ISA Pharmaceuticals is looking for highly qualified, enthusiastic and entrepreneurial people to join its team. ISA values people who are excited about what they do, have high standards of integrity and can motivate themselves and those around them to achieve results.

The company culture of ISA is built on four important competences: high quality knowledge, a pragmatic & solution-oriented attitude,  we are agile & resilient and appreciate collaboration & learning.

If you want to play a role in improving clinical outcomes for patients and to help build a rapidly growing and successful company, we would like to hear from you. For general inquiries on job opportunities, please contact Gerben Moolhuizen at recruitment@isa-pharma.com.

We currently have the following job openings (further description below).

  • QA Officer (24-40 hrs/wk)
  • Senior Medical Advisor
  • CMC Project Manager
  • Regulatory Affairs Manager
  • Associate Project Manager

 

QA Officer (24-40 hrs/wk)

Your challenges are to participate in projects in the exciting field of cancer immunotherapy and to support the manager QA and QP in execution and development of the QA system  by assessing and approving quality documentation. You have an important role in maintaining the  documentation system and QA and clinical archives. Furthermore you assist in improving the compliance of ISA in relation to GMP production, release and R&D activities. This function can be a part time function.

You have a BSc or MSc-degree in Biology or in a Life Sciences-related area, you have hands-on experience with QA and documentation systems, reviewing and archiving of QA documentation like change requests, deviation reports, complaints and CAPAs. Furthermore you are able to review R&D study protocols and reports as well as GMP production batch records. You are a flexible person with good communication skills, who acts as a team player and is able to work accurately and independently.

We offer you a challenging position in a rapidly developing organization. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth.

For further information on this job opening and related career opportunities, please contact Willem-Jan Krebber at recruitment@isa-pharma.com or +31 71 3322310. Acquisition based on this advertisement is not appreciated.

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Senior Medical Advisor

You provide medico-scientific support and expertise to the assigned clinical development program and relevant clinical trials. You assist with clinical trial design, set-up, and execution as well as final study report and closure- within GCP requirements. You will be part of a compact clinical research group and we expect you to collaborate well with internal and external partners (CRO’s); you will also liaise with experts and key opinion leaders. You support change management and continuous improvement efforts across programs, identifying and addressing gaps and opportunities.

You are a registered Medical Practitioner in the EU with a minimum of 2-3 years of industry experience, preferably in clinical drug development. You have excellent analytical and interpersonal communication skills and you effectively communicate progress toward milestones, opportunities, and risks to all stakeholders. You have a background in clinical research (preferably oncology) with a working understanding of GCP. You are based in the Benelux and able to work from our offices in Leiden at least part of the time. You are prepared to travel internationally for work.

We offer you a challenging position in a rapidly developing organization and competitive remuneration as well as work/life balance. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth. For further information on this job opening and related career opportunities, please contact Leon Hooftman at recruitment@isa-pharma.com or +31 71 3322310.

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CMC Project Manager

Your challenges are to drive partner CMC (Chemistry, Manufacturing and Controls) manufacturing and validation projects based on ISA’s proprietary SLP® platform. You will help revolutionize clinical development by exploring new technology innovations and regulatory pathways for our products.

In addition to project management tasks, you will coordinate, write, and review CMC documentation such as project plans, reports, and regulatory filings. You will closely collaborate with other departments as well as with external partners.

You have a MSc or PhD degree in Life Sciences or Chemistry with over 5 years relevant experience. You will be the key project interface for and between the ISA (project) teams and our GMP manufacturers of drug substance and drug product. You have experience with project management and regulatory submissions and knowledge of quality systems and GMP manufacturing and preferably process validation. You are flexible, possess good communication skills, and can act as a team player as well as team leader. You have a can-do mentality and good problem solving skills.

We offer you a challenging position in a rapidly developing organization. You will be part of a team of young top professionals, work with state of the art equipment and technologies in an inspiring environment with opportunities for personal and professional growth. For further information on this job opening and related career opportunities, please contact Brigitte Burm at recruitment@isa-pharma.com or +31 71 3322310.

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Regulatory Affairs Manager

You are accountable for the development and implementation of the regulatory strategy for one or more ISA products, so that these will be rapidly approved with the desired label. You work closely together with our internal drug development teams and our external advisors and become responsible for communication and interactions with FDA, EMA and other relevant authorities. You drive preparation of all regulatory applications. You closely monitor the regulatory landscape to keep abreast of new developments and effectively communicate them across the company.

You have a MSc degree (or comparable) in Medicine, Healthcare, Life Sciences or related field. You have a minimum of 6 years of relevant work experience in Clinical Development or CMC (of which at least 2 years focus on Regulatory Affairs) preferably in the field of biologicals, rare diseases and orphan designations. You have comprehensive knowledge of EU and US regulations and have proven ability to implement these into regulatory strategies. Within pharmaceutical or biotech setting, you have experience in driving MAA/NDA submissions.

We offer you a challenging position in a rapidly developing organization. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth.

For further information on this job opening and related career opportunities, please contact Leon Hooftman at recruitment@isa-pharma.com or +31 71 3322310.

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Associate Project Manager

You provide PM support to ISA’s pipeline projects and cross-functional development projects through stage gate reviews and delivering milestones on schedule. You manage the implementation of PM processes, tools and templates (Gantt charts, action and decision logs, RACI’s, risk registers). You harmonize PM practices across ISA and provide support for strategic Program Management pipeline projects. You bring value in planning, organizing and integration of projects. You support change management and continuous improvement efforts across programs, identifying and addressing gaps and opportunities.

You have an MSc or BSc degree in Sciences with 2-5 years of experience in (Clinical) Project Management, preferably in Life Sciences (biotech/pharma/devices). You have excellent interpersonal communication skills and you effectively communicate progress toward milestones, opportunities, and risks to all stakeholders. You are proficient in Microsoft Office Suite and Microsoft Project. You are able to understand and pick up new things quickly. Being a Certified Associate in Project Management (CAPM) or Project Management Professional (PMP) certificate are preferred.

We offer you a challenging position in a rapidly developing organization. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth.

For further information on this job opening and related career opportunities, please contact Ciska van Doesum at recruitment@isa-pharma.com or +31 71 3322310.