Project Manager CMC

As Project Manager CMC you will play an important role in the continued manufacturing and supply of drug substance and drug product for the CAP-100 clinical development program. Together with a small team of entrepreneurial, science-loving colleagues, you will contribute to the development of a new antibody medicine which addresses unmet needs in the treatment of hematological cancers. Recently we obtained FDA Clearance of our IND Application for CAP-100 and the first study in patients will start shortly.

The role:

As Project Manager CMC  your main tasks and responsibilities are the following:

  • Managing external CMC projects of Catapult;
  • Securing timely resupply of CAP-100 drug product for the ongoing clinical development.
  • Managing the availability of clinical supplies, including labeling and packaging and expiry date setting;
  • Driving CAP-100 manufacturing optimization in collaboration with outsourcing partners.
  • Reviewing of plans, reports and other critical documents of (outsourced) CMC activities;
  • Ensuring that process development and manufacturing activities are conducted in line with good scientific principles and design, in compliance with regulatory guidelines and according to GMP, GLP and/or GDP, where applicable;
  • Selecting and performance monitoring of Contractors for CMC activities;
  • Assisting in preparing and reviewing regulatory filings;
  • Monitoring and updating project plans and timelines in relation to the outcome of developmental work;
  • Reporting on status and planning of CMC activities on a pro-active basis;
  • Ensuring that conflicts between Catapult and Contractors are timely detected and properly solved or escalated, where needed.

 Your profile:

We are looking for a Project Manager CMC with the following knowledge and expertise:

  • You hold at least a Master’s degree in a relevant biomedical field, and have at least 3 years of project management experience in the biotech or pharma industry;
  • You have good understanding of various quality systems such as GMP, GLP and GDP;
  • You are a hands-on team player focused on results;
  • You are known for your organizational skills and drive to continuously improve your work;
  • You communicate well in English, both verbal and in writing;
  • Experience with late stage CMC development activities and/or drug product manufacturing of biologicals is a strong pre.

What we offer

The position offers an opportunity to work within a small team, with great autonomy and entrepreneurial, science-loving colleagues, all of whom are committed to improving the lives of patients.
Catapult Therapeutics’s offers an informal ambitious working environment. We offer a market conform salary and a good pension plan. The right candidate will be welcomed enthusiastically.

Interested? Please send us your CV and motivation letter. Contact Iris Garnier for more information.
Recruiters should not contact us.

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Clinical Trial Operations Manager

Catapult Therapeutics is a privately held Dutch biotech company developing CAP-100 – an innovative first-in-class humanized anti-CCR7 antibody.

Catapult Therapeutics was established in 2015 as a joint venture between Spanish and Dutch partners. Catapult is founded on the discoveries of Dr Cecilia Munoz and her group at Hospital La Princesa in Madrid. They identified and validated CCR7 as a therapeutic target for leukemias and lymphomas. Technology of Dutch biotech company Pepscan made it possible to generate antibodies against human CCR7.

The chemokine receptor CCR7 is over-expressed in many cancers, and high CCR7 expression is associated with poor prognosis and short survival in hematological and solid malignancies. Preclinical studies have shown that the anti-CCR7 antibody can prolong survival and inhibit cancer cell migration in multiple animal models of B-cell and T-cell lymphomas.

CAP-100 has a uniquely differentiated mechanism of action, which is complementary to current standard of care treatments for hematological malignancies. Thus, CAP-100 is a potential monotherapy and can be used in combination with current standard treatments.

CAP-100 has completed preclinical development, with IND filing in December 2020. The preparations for the start of the first study in patients are ongoing.

The opportunity

Catapult Therapeutics is currently entering the clinical trial phase 1. To realize our ambition, we are looking for a hands-on clinical trial operations manager with proven knowledge of all aspects of clinical operations, preferably in oncology.

The basic responsibility is to deliver and execute the Catapult clinical development strategy for CAP-100 in a cost effective, safe and regulatory compliant fashion.

Proficiencies

The ideal candidate with life science background has a sound understanding of the pharmaceutical development process and has proven clinical trial experience. The candidate has a good understanding of stakeholder management, is accountable as project manager, and is thrilled by being in the frontline of breakthrough developments in cancer therapies. It’s a great advantage if the candidate has led the successful early clinical development of a new product.

Your responsibilities

  • Ensuring projects are conducted according to defined scope, quality, budget and timelines.
  • Oversight of Contract Research Organizations (CROs) and other vendors appointed by Catapult for the conduct of clinical trials
  • Coordination of investigational medicinal product supply
  • Co-monitoring of investigational sites to assure that clinical research is being carried out in full compliance with relevant requirements.
  • Participation in development and review of clinical documentation and relevant clinical Quality Management System and conduct of vendor qualification audits.
  • Arranging for submission and approvals by ethics committees and competent authorities together with regulatory affairs staff
  • Representing clinical operations in the overall Catapult project team.
  • Participation in the writing and review process of medical sections of regulatory documents for EU and US applications; assisting team with preparations for regulatory agency meetings and reports.

Your education, skills and experiences

  • Degree in (bio-)medical, biological, biotechnology sciences or equivalent by experience; MSc preferred.
  • 5+ years’ work experience as a CTM or equivalent for pharmaceutical/biotechnology company or CRO.
  • Experience in oncology or immunotherapy is highly desired.
  • Understanding of clinical trial methodology and operations
  • Must be able to work on multiple simultaneous tasks with limited supervision
  • A self-motivated, energetic and detail-oriented professional with an affinity for project management
  • Result oriented and proactive attitude with a can-do mentality. High standards, self-starter.
  • Open-minded and creative problem solver who is punctual, takes ownership, and can deal with competing priorities and challenges
  • Demonstrated capabilities in building relationships based on trust, engagement and long-term commitment

Your profile

  • Entrepreneurial
  • Excellent interpersonal skills
  • Excellent oral and written communication skills (English)
  • Project management skills
  • Passion for clinical excellence
  • Sound decision making capabilities
  • Willingness to travel abroad (mainly US/EU)

What we offer

The position (32-40 h/week) offers an opportunity to work within a small team, with great autonomy and entrepreneurial, science-loving colleagues, all of whom are committed to improving the lives of patients.

Catapult Therapeutics’s offers an informal ambitious working environment. We offer a market conform salary and a good pension plan. The right candidate will be welcomed enthusiastically.

Interested? Please send us your CV and motivation letter. Contact Iris Garnier for more information.
Recruiters should not contact us.