Are you passionate about supply chain and eager to gain hands-on experience in the pharmaceutical industry? Our company is offering an exciting internship opportunity for a Supply Chain – Business Process Intern to join our team!

As a Supply Chain – Business Process Intern, you will play a key role in supporting our supply chain operations with a focus on process documentation, process definition, and data gathering. This internship is designed to provide practical experience in understanding and improving business processes within a dynamic pharmaceutical environment. Reporting to the Sr. Supply Chain Manager, you will collaborate closely with the team to help enhance operational efficiency and support both clinical trial and future commercial activities.

Your role

Assist in the documentation and review of supply chain business processes (e.g., procurement, logistics, planning).
Support data gathering and analysis for performance tracking and reporting.
Help identify process bottlenecks and suggest improvements.
Collaborate with cross-functional teams (e.g., procurement, quality, manufacturing) to support supply chain initiatives.
Assist in preparing SOPs, workflow diagrams, and training materials.
Participate in team meetings and contribute to ongoing projects and process enhancement activities.
Perform other administrative and project support tasks as needed.

Your profile

Currently pursuing a Bachelor’s or Master’s degree in Supply Chain Management, Logistics, Business Administration, Industrial Engineering, or a related field.
Strong analytical and problem-solving skills.
Proficiency in Microsoft Office (Excel, PowerPoint, Visio); familiarity with data visualization tools is a plus.
Good communication, collaboration skills, adaptability / willingness to learn.
Proactive, detail-oriented with the ability to multitask and meet deadlines.

Our offer

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day of your internship. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer internship compensation and flexible working hours and working times. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

We are seeking a Financial Controller for our Finance & Accounting team, based in our Utrecht office. Our team, consisting of five professionals, is dedicated to managing key financial accounting responsibilities for our two entities: the Dutch N.V. and the US Inc.

In this role, you will contribute to preparing and executing detailed monthly accounting transactions, journal entries (including PO and non-PO), ensuring compliance with SOX and US GAAP in predominantly the area of R&D, Clinical and CMC accounting . You’ll provide crucial support to colleagues in both the Netherlands and the US, working closely within the team to meet stringent timelines and requirements for both the N.V. and Inc. books. This position demands a deep understanding of accounting, the ability to oversee the bigger picture, and a commitment to continuous improvement and optimization in our financial operations.

Your role

· Accounting and Transactions: Prepare and execute monthly accounting transactions, including journal entries for Preclinical, R&D, clinical accruals, drug substance/product accruals, and pre-paid expenses, ensuring detailed tracking and reconciliation on a monthly basis.

· Collaboration and Oversight: Work closely with accounting peers, internal project managers (R&D, Clinical and CMC), and other stakeholders like, critical vendors, supply chain and vendor management to align on transactions and track purchase orders (POs) and contracts.

· Review and Approval: Oversee the accuracy of financial documents, including (Pre) Clinical and CMC trackers, and approve the work of others, ensuring compliance with accounting standards.

· SOX Controls and Internal Audits: Manage and execute SOX controls, ensuring adherence to internal control guidelines, and maintain documentation for audits.

· Continuous Improvement: Lead initiatives for internal control and process improvements, aiming to enhance efficiency and accuracy in financial operations.

· Stakeholder Engagement: Engage with both internal teams and external specialists, including auditors and SOX specialists, to support financial operations and compliance.

Your profile

We seek a detail-oriented and analytical individual with a proactive approach and a strong commitment to accuracy and quality. The ideal candidate is hands-on, results-driven, and excels in planning and organization, with advanced Excel skills. You should possess excellent interpersonal and communication abilities, as recognized by your peers, and have a knack for driving improvements and achieving high output.

· Relevant education on master level in Accounting or (Business) Economics

· Experienced to work with SOX 404b compliance in a US listed public company

· Experienced with integrated audits

· You are proficient in all areas of financial accounting

· SAP experience is an advantage

· Previous work experience in biotechnology or pharmaceutical industry or audit practice is advantageous

· You are fluent in Dutch and English

· You are able to work in an international environment across time zones

Our offer

We offer a competitive salary and flexible working hours. Our talented international team works in an inspiring area of Utrecht (Utrecht Science Park) in a brand new state-of-the-art facility. We also offer an excellent pension scheme, company bonus, and 30 days’ annual holiday based on a full-time position. We care about team spirit and organize several company events each year.

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients’ lives. We have bold aspirations, because the need is great and the patients are waiting. Join us and make an impact.

Your role

Merus is seeking an Associate Director/Director, Program Management responsible for providing program management to support global clinical development plans for clinical candidates in various stages of development. This position will be reporting to the Sr. Director Program Management / Head of PMO. The individual will work closely with the Program Lead and be responsible for the planning, monitoring and execution of significant cross-functional projects and identifying operational excellence initiatives to drive efficiencies for key corporate and development milestones.

The Associate Director/Director, Program Management works cross functionally partnering with executive leadership, technical leads and subject matter experts across the development, operations, regulatory and quality functions to support advancement of the Company’s pipeline and operations.

The individual will be responsible for management and delivery of the integrated project and program plans, tracking progress against goals with GANTT charts, working cross-functionally to identify risks, opportunities and mitigations. Setting regular meeting reviews, agendas, minutes and action items to ensure robust documentation and oversight will be core to this role. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables. The role will require proven project leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to drive key initiatives across the organization.

In this role you will:

Align programs with business objectives and organizational goals
Manage complex, high-impact global programs in a matrix environment
Support development of the Program Management Office (PMO), and consistent implementation of Program Management (PM) tools and processes across portfolio to deliver improved business performance, higher efficiency, and excellence in execution
Foster best practices in communication and alignment across the program team, functional teams, and other key stakeholders
Responsible for ensuring effective, accurate, and timely communication of project information to the leadership team and other relevant stakeholders to ensure single source of truth for the development programs
Execute and drive long-term strategic direction for programs, work closely with relevant functions to translate strategy into robust and realistic program and development plans;
Take end-to-end ownership of program outcomes, keeping in mind budget, timelines and scope
Drive alignment to develop executive-level reports to peers and senior management
Organize and facilitate cross-functional program teams. Prepare, lead, and document team meetings
Develop high-level, and detailed schedules (GANTT charts) across functional teams, build program budgets, and anticipate resource constraints or process bottlenecks
Monitor and proactively manage program sub-team deliverables, track progress against milestones, flag resource or process bottlenecks, and adjust and correct as needed
Anticipate, identify, quantify and escalate issues and risks as appropriate; propose and develop enterprise-wide mitigation strategies; maintain program risk log

Your profile

We are looking for a candidate with:

MSc or PhD with 5+ years project management experience in Biotech/Pharma, with at least 2+ years as the lead PM on a program in Ph3 trials
Background in a relevant biomedical field (e.g., molecular biology, protein chemistry, cell biology, immunology)
PMP® certification and experience with MS Project
Strong leadership, communication, and interpersonal skills, with the ability to collaborate and coordinate across all levels of the organization
Demonstrated ability to develop trusted relationships and maintain integrity
Excellent program management and organizational skills, with experience managing multiple initiatives simultaneously
Located in Boston, MA area

Our Offer

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.

We are seeking a detail-oriented and highly organized CMC and Supply Chain Assistant to join our team. The CMC and Supply Chain Assistant will support the Chemistry, Manufacturing, and Controls (CMC) and the Supply Chain department by providing administrative assistance. The ideal candidate will have strong administrative and good communication skills.

Your role

Providing day-to-day administrative support to the team, including calendar management, meeting scheduling, and document filing.
Supporting in processing legal documents (e.g. contracts and confidentiality agreements) in Veeva Vault.
Supporting in creating and updating of Purchase Orders in SAP.
Supporting in quarterly budget reporting activities
Assisting in preparing materials for CMC-related meetings, taking minutes, and following up on action items.

Your profile

Proven experience (1-3 years) in an administrative role, preferably within the pharmaceutical, biotechnology, or life sciences industry.
Strong organizational skills and attention to detail.
Excellent written and verbal communication skills both in Dutch and in English.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Proficiency in SAP and Veeva Vault (preferred).
Ability to manage multiple tasks and deadlines in a fast-paced environment.
Strong problem-solving skills and ability to work independently and as part of a team.
Affinity with finance and legal tasks.

Why Merus?

Join our mission to close in on cancer. We are seeking a Senior Director for the Clinical Operations team with a focus primarily on Clinical Compliance and Inspection Readiness. This role involves leading the clinical operations teams with a focus on compliance and overseeing the management of all compliance activities on our programs to ensure inspection-ready at all times.

Your role

The Senior Director, Clinical Compliance/Inspection Readiness is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues which will include:

Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization.
Lead the development and implementation of processes and tools to support teams and functions in being inspection-ready.
Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring.
Prepare and execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding.
Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities.
Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
Generate, analyze, and communicate oversight, compliance, and inspection readiness metrics.
Drive continuous improvement into inspection readiness and inspection conduct support.
Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms, and templates in compliance with global regulatory standards.
Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization.
Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance.
Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
Generate, report, and respond accordingly to compliance/inspection readiness KPIs.
Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.

Your profile

The ideal candidate will have extensive experience with compliance processes, regulations, oversight documents, training, and Quality systems and will be responsible for oversight of compliance in all programs and of our eTMFs.

Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
12-15 years of experience in global clinical trials and operations.
Experience with compliance processes and implementation, preparation, and conduct of audits and audit follow-up including CAPA creation and completion, previous inspection preparation experience, inspection execution, computerized clinical trial records management technologies, particularly Veeva systems. Experience in storyboard creation and driving and training teams towards implementation of storyboard creation and filing.
5-8 years of personnel management experience, with a proven track record of mentoring and developing teams.
Strong organizational, writing, and communication skills.
Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.

Our offer

The Clinical Operations team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I-III studies in oncology, most of them first in class compounds. We are seeking a TMF Administrator and Subject Matter Expert (SME) for our electronic Trial Master File (eTMF) team. This role involves supporting the internal clinical and cross-functional project teams with respect to maintenance, review, metric creation, filing, documentation and organization of the Trial Master File and ensuring it is inspection-ready at all times.

The role

As a TMF Administrator and SME, your main tasks and responsibilities are the following:

Ensure the TMF is compliant and ready for inspections by auditors and regulatory authorities act as an SME, administrator and business owner of the internal eTMF system.
Lead the development of a process for internal upload of documents into the eTMF, the QC, review and oversite processes of the eTMF as well as the creation and necessary editing of procedural documents, Standard Operating Procedures( SOPs), Work Instructions (WIs)TMF management plans and Indices, and all other related materials.
Provide training to all project team members as to the importance of the TMF and a “how to” on the review process of all of the documents within the different TMF sections.
Provide back-up to CTAs and other project team members to support upload to the eTMFs and the review processes as necessary.
Provide review of eTMF metrics and guidance to the project teams in the continuous review of the eTMF (internal & external) and the oversight of the collection of external vendor documents for TMF upload and filing.
Support the cross-functional team in the provision of documents for eTMF upload and the QC of documents in the eTMF according to TMF oversight plan.. Act as an SME on the Veeva quality system for all project teams.
Have participated in TMF migrations and processed all necessary documentation as part of the migration, including the pre and post QC processes.
Be a point of contact for all internal eTMF related questions for cross-functional project teams.
Grant Access for new Users to related Records as CBA and update Merus Veeva eTMF access tracker.

Your Profile

The ideal candidate will have extensive experience with Veeva Quality systems.

Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
Ideally Veeva Quality certified or if not certified, extensive experience in the Veeva quality system
5 years of TMF support experience in global clinical trials.
Experience with computerized clinical trial records management technologies, particularly Veeva systems.
Strong organizational, writing, and communication skills.
Knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.
Demonstrated ability to collaborate effectively across teams and departments.
A strong sense of urgency with the ability to prioritize tasks and meet deadlines.
Proven track record of managing multiple programs simultaneously while maintaining quality and efficiency.

Our offer

As a member of our CMC (Chemistry, Manufacturing & Control) Team you will play an important role in the cell line, process and formulation development and drug substance and drug product manufacturing of bispecific antibody leads, and contribute to the development of groundbreaking new medicines for the treatment of cancer.

Your Role:

Supporting early and late stage development activities through scientific and technical input to 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;
Prepare/review technical documents including development/validation/transfer protocols and reports;
Evaluating change controls and deviations related to CMC activities;
Participating in cross-functional subteams;
Providing day-to-day expertise to CMC project teams on manufacturing and other development activities, manufacturing scale-up considerations and GMP operations;
Provide input and review support for regulatory submissions;
Reporting on status and planning of CMC activities on a pro-active basis.

Your Profile:

You hold at least a Master’s degree in a relevant biomedical field, and have at least 5 years of experience in CMC in the biotech or pharma industry;
Experience in antibody development as well as antibody drug substances and/or drug product manufacturing is a strong pre;
You have good understanding of various quality systems such as GMP, GLP and GDP;
You are known for your organizational skills, accuracy and drive to continuously improve your work;
You communicate well in English, both verbal and in writing.

Why Merus?

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®) to discover and develop innovative medicines for cancer patients. Working at Merus offers you the opportunity to contribute to our mission of closing in on cancer. We are a global and diverse team of dedicated professionals who are deeply committed to making a difference in patients’ lives. Join us and make an impact.

Your Role

Merus is seeking a Senior Manager Supply Chain Management to develop and implement end-to-end supply chain strategies for investigational medicinal products (IMP), comparator drugs, and necessary equipment for clinical trials and future commercial activities. You will lead a small team of subject matter experts responsible for day-to-day supply chain operations in assigned clinical trials.

Key Responsibilities

Oversee monthly demand & supply planning, managing forecasting models, and providing analyses and reports for key stakeholders.
Ensure effective inventory management across the supply network, setting targets, monitoring execution, and identifying potential imbalances.
Develop and maintain the supply planning calendar, ensuring alignment with ongoing projects.
Procure and coordinate labeling of commercial supplies in collaboration with Clinical Operations.
Lead and manage a team to ensure smooth execution of day-to-day supply chain activities.
Drive improvement initiatives to enhance supply chain capabilities within Merus.
Provide support for clinical site supply issues, including shortages, recalls, and disruptions.
Contribute to vendor selection and management for supply chain services.
Support system development and testing of supply chain-related applications, including IRT.

Your Profile

We are looking for a candidate with:

A Master’s degree in Operations, Supply Chain Management, or a related field.
10+ years of relevant experience in clinical supply chain operations, preferably in Phase 3 trials.
5+ years of experience in a leadership role.
Strong knowledge of GxP regulations.
Excellent analytical and process-oriented skills with a proactive problem-solving mindset.
Strong stakeholder management and collaboration abilities.
Fluency in English (written and verbal).
Experience with supply chain software, ERP systems, and data analysis tools.
Ability to handle multiple priorities and work in a fast-paced environment.
Willingness to travel occasionally.

Our Offer

Your role:

We are seeking an Associate Director for our electronic Trial Master File (eTMF) team. This role involves leading the eTMF team and overseeing the management of all eTMF activities, ensuring that the Trial Master File is inspection-ready at all times.

In this role you will:

As Director eTMF, you will act as the TMF Subject Matter Expert for the clinical study team and support cross-functional departments to ensure high-quality documentation.
Lead and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert.
Be responsible for the setup, management, archiving processes, and execution of Vault, including naming conventions, processes, migrations, etc.
Ensure the TMF(s) for each program are compliant and ready for inspections by auditors and regulatory authorities (TMFs with CRO partners and the internal Veeva Vault system).
Drive and enforce timelines with a sense of urgency to meet clinical trial deadlines, as well as corporate/department goals and objectives.
Lead the development of procedural documents, SOPs, etc., and oversee the creation of individual project TMF management plans and related materials.
Act as a primary point of contact for project teams for guidance, oversight, metric creation, and review, as well as a key liaison for CROs, auditors, IT, and external parties.
Review and resolve discrepancies within eTMFs, ensuring timely reporting and internal reviews.
Participate in clinical operations meetings, audits, and inspection readiness activities, ensuring smooth preparation.
Identify and implement continuous process improvements in collaboration with stakeholders.
Manage budget proposals from third parties related to eTMF activities or systems, ensuring alignment with business needs.
Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements.
Guide and provide metrics for CRO and internal TMF systems to reflect TMF status and health accurately.
Oversee access management and ensure appropriate internal and external access to the eTMF system. Be the system owner and expert for Veeva Vault at Merus.
Ensure compliance with global regulations and guidelines for TMF management, staying current with changes in industry standards.

Your Profile:

The ideal candidate will have extensive experience with Veeva Quality systems and will be responsible for training and supervising eTMF staff.

Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
8-10 years of TMF management experience in global clinical trials.
Experience with computerized clinical trial records management technologies, particularly Veeva systems.
4-5 years of personnel management experience, with a proven track record of mentoring and developing teams.
Strong organizational, writing, and communication skills.
Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.

Our offer

Your role

Merus is seeking a Finance Operations Manager who embodies a hands-on approach and thrives in an international setting, adept at navigating across time zones (Merus has offices in the Netherlands and US). This role is crucial to the success of Merus Finance Operations and is an exciting opportunity for a finance professional dedicated to innovation, collaboration and excellence. This position will be reporting to the Director of FP&A.

In this role you will:

Manage financial system SAP Business ByDesign, optimize the configuration and reporting needs, provide information to allow strategic and operational decision-making. This includes management of organizational structure, cost centers, projects, approval flow, Purchase Order review and approval etc.
Help business navigating through SAP i.e. give training to business on how to review and approve POs and supplier invoices, how to create a purchase order. Trouble shoot SAP issues for business or with the help of IT
Support quarterly accounting close process by directly interacting with business representatives
Identify opportunities for improvement, supports development and implementation of improved processes, tools and templates
Support the development of the annual budget and reforecast, long-range planning, ensure the ongoing tracking and management of these budgets/forecasts.
Build relationships cross-functionally to foster collaboration both inside and outside of the Finance team
Play a key role in special projects, including cross Finance improvement initiatives or ERP system implementations driving financial efficiency and strategic growth

Your profile

We are looking for a candidate with:

Bachelor’s degree in Finance or Accounting. (MBA is a plus)
7+ years relevant experience in a financial planning and accounting role
Experience in the Pharmaceutical or Biotech industry (or similar) is required
Ability to understand and explain complex R&D financial underpinnings into clear and concise analysis and recommendations
Extensive experience in use of Excel and PowerPoint at an advanced level
Strong collaboration skills to coordinate efforts and accomplish goals as a team
Excellent interpersonal, verbal and written communication skills
Ability to handle and (re)-prioritize multiple assignments and to meet deadlines in a fast-paced working environment
Ability to work across departments and time zones.

Your role

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Why Merus?

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