Ardena Careers

Director

• You define and oversee all analytical development and GMP-compliant QC activities across small and large molecule projects, ensuring scientifically sound and phase-appropriate approaches.
• You plan and organize departmental activities and resources to consistently meet or exceed targets related to quality, productivity, timelines, and capacity.
• You drive the implementation of new analytical techniques, technologies, and digital solutions, in close collaboration with validation and maintenance, to expand the service offering and improve efficiency.
• You lead, coach, and develop Group Leaders and (Associate) Scientists, ensuring clear goal setting, strong performance management and continuous team development.
• You support the professional growth of team members through structured feedback, coaching, and targeted training initiatives.
• You collaborate closely with cross-functional stakeholders (Formulation Development, Production, Quality, Project Management) to resolve issues, define priorities, and translate these into clear, actionable plans.
• You provide strategic and technical input to client proposals, defining appropriate analytical strategies aligned with project scope and regulatory expectations.
• You are a member of and contribute to the local Management Team, actively supporting site strategy, operational decisions, and continuous improvement initiatives.
• You demonstrate the ability to strategically leverage AI and digital technologies to enhance Analytical Development performance, decision‑making, and innovation. You apply AI in a compliant, data‑driven manner to improve efficiency, quality and scientific insight, while guiding your team in responsible and effective AI adoption.
• You report to the Site Head of the Drug Development & Manufacturing Business Unit.

Director Analytical Development

• Central point of contact for all Quality-related matters within the organization
• Developing and implementing quality policies and procedures
• Leading the Quality department and ensuring necessary training and development of employees
• Supervising and participating in internal and external audits
• Analyzing quality data and reporting findings to the Management Team
• Collaborating with GMP Production, R&D, and analytical department to resolve quality issues
• Shaping strategy and processes for the Ghent site within the Ardena group
• Reconciling business objectives with legal quality requirements
• Ensuring AI is effectively embedded across quality processes

Quality Director

Business Development Rep

• Proactively develop business opportunities for contract manufacturing by prospecting for and calling on pharmaceutical and biotech companies
• Work with site leaders to successfully meet commercial Sales targets
• Partner with internal sales/marketing and technical support teams to quickly assess and qualify prospects
• Respond to incoming leads and inquiries from multiple-sources, and qualify through business analysis, customer evaluations, and strategic fit
• Engage in the preliminary selling stage of the sales cycle through close of project and beyond
• Effectively manage your deals through our CRM system
• Present the value proposition for Ardena's capabilities and services to customers, and facilitate on-site capabilities presentations and support customer onsite visits
• Increase the financial return of each project by maximizing each lead and educating the client on all of the solutions available throughout the Ardena network
• Ensure a successful transition to Project Management when appropriate, while maintaining strong client relationships leading to future business development opportunities
• Ability to attend local trade shows and conferences as needed
• Other duties as assigned

Director of Business Development

Research Scientist

• Lead the development of amorphous solid dispersions (ASD) and solubility-enhanced oral dosage forms using hot melt extrusion (HME) and spray drying as the primary technology platforms, from preclinical concept through clinical and commercial formulation.
• Apply expertise in solid oral dosage form development — encompassing formulation design, process development, scale-up, and technology transfer — across preclinical, clinical, and commercial stages.
• Define pilot plant batch manufacturing requirements, oversee study execution, and provide technical consultation during clinical and commercial batch manufacture.
• Collaborate with the preformulation team to characterize materials using DSC, TGA, XRPD, SEM, and hot-stage microscopy; interpret data and apply findings to formulation strategy.
• Author high-quality GDP-compliant technical documents including development reports, technical specifications, project risk assessments, and regulatory CMC submissions in accordance with applicable guidance and site SOPs.
• Design and interpret experiments using statistical analysis, design of experiments (DoE), and data visualization tools to support robust development decisions.
• Plan and organize assigned work across multiple concurrent projects, prioritizing effectively to meet scientific, regulatory, and client timelines.
• Develop formulation strategies and lifecycle plans that align with regulatory requirements and client objectives.
• Proactively acquire and apply new scientific principles and technologies with minimal direction.
• Ensure compliance with Health, Safety, and Environmental requirements; maintain current training records for all required procedures.
• Contribute to the training and mentoring of junior R&D personnel as required.
• Communicate scientific findings clearly and persuasively in written and verbal formats to both internal teams and external clients.
• Manage difficult client discussions constructively, guiding conversations toward acceptable resolutions.
• Enhance Ardena’s scientific visibility through publications, webinars, conference presentations, and symposia.
• Support departmental goals by delivering high-quality technical work and maintaining strong client relationships.
• Identify and recommend emerging technologies with potential application to Ardena’s solubility enhancement service offerings.
• Understand the structure and content requirements of CMC regulatory filing packages; author and review formulation and analytical sections of regulatory submissions.
• Publish or present research findings internally and externally to advance scientific knowledge and Ardena’s profile.

Principal Scientist – Solubility Enhancement Technologies

• Ensure the site operates in full compliance with regulatory and internal standards
• Ensure robust oversight of: batch certification, deviations, CAPA, change control, complaints and recalls, validation and qualification
• Drive a proactive quality culture focused on Right-First-Time and data integrity
• Translate corporate strategy into site-level quality objectives and KPIs
• Act as a business partner to General Manager, Operations, and Commercial teams
• Balance compliance, cost, cycle time, and customer expectations
• Support business growth by enabling: On-time product release, Inspection readiness, regulatory approvals
• Contribute to client interactions and proposals, ensuring quality positioning is competitive and credible
• Drive measurable improvements in: cycle time (e.g., batch release, deviation closure), Right-First-Time performance, Cost of Poor Quality (COPQ)
• Build, lead, and develop a high-performing quality organization
• Foster a culture of: accountability, ownership, cross-functional collaboration
• Ensure appropriate succession planning and capability development
• Coach teams on risk-based thinking and pragmatic GMP application
• Implement robust quality risk management (ICH Q9) practices
• Maintain a constant state of inspection readiness

Site Quality Director

• Identify and qualify, early‑stage through late phase opportunities across biotech and pharma.
• Execute structured outreach via calls, email sequences, LinkedIn campaigns, and in‑person drop‑ins.
• Travel up to 50% to visit prospects, attend events, and represent Ardena in person.
• Attend local biotech meetups, innovation gatherings, and industry mixers to expand Ardena’s visibility.
• Introduce Ardena’s integrated CRDMO services to new audiences and ensure consistent market messaging.
• Actively seek out new development and manufacturing programs aligned with Ardena’s capabilities.
• Additional Duties as assigned.

Business Development Associate

Affiliate Manager

• Act as a trusted HR business partner to site leadership and managers, offering guidance on complex employee relations, performance management, disciplinary and grievance matters, ensuring fair, consistent and legally compliant outcomes.
• Support recruitment and onboarding activities by partnering with hiring managers, advising on selection strategies, participating in interviews, and ensuring a smooth induction experience that meets compliance and safety requirements.
• Drive performance management processes, coaching managers on objective setting, regular feedback, probation reviews and performance improvement plans; support talent calibration and succession planning activities.
• Develop, implement and maintain HR policies and procedures in line with Ardena standards; ensure policies are communicated and applied consistently across the site.
• Deliver learning and development initiatives in collaboration with HR colleagues, including onboarding, compliance training and targeted development programs that build capability and engagement.
• Manage HR administration activities, including HRIS records, contract changes, absence management, benefits administration and HR reporting to ensure accurate and timely people data.
• Provide HR metrics and analysis (headcount, turnover, absence, recruitment KPIs) to support decision-making and continuous improvement of people practices.
• Support employee engagement initiatives and site culture activities that reinforce Ardena’s CARE values: Communicative, Accountable, Reliable and Excellent.
• Ensure compliance with relevant employment legislation and support internal and external audits or inspections related to HR practices.
• Lead AI-driven process improvement and automation initiatives across HR programs.

HR Manager – HR Business Partner

• Hold full P&L accountability for the Bioanalytical Business Unit, including revenue performance, cost control, margin optimization, and financial outcomes
• Lead annual budgeting, quarterly forecasting, and long‑range planning, including OPEX and CAPEX
• Develop and execute business strategies that drive sustainable growth, profitability, and return on investment
• Establish and monitor financial, operational, and commercial KPIs, translating data into decisive action
• Build, launch, and scale the U.S. bioanalytical laboratory with strong scientific capability and operational excellence
• Ensure high‑quality delivery of GLP and non‑GLP bioanalytical studies
• Provide visible, inspiring leadership; coach, develop, and empower a high‑performing leadership team
• Serve as the senior scientific and business representative for prospective and existing clients

Director – Bioanalytics

• Proactively develop new business opportunities for contract research services by prospecting, networking, and calling on biotechnology and pharmaceutical companies, with a strong emphasis on the Boston, MA market.
• Maintain a high level of in‑person customer engagement in the Boston area through regular meetings, site visits, and industry participation.
• Evaluate and assess contract research opportunities by understanding customer scientific objectives, development strategies, timelines, and business priorities.
• Partner with internal scientific, technical, and operational teams to assess feasibility, scope, and alignment of prospective opportunities with organizational capabilities.
• Engage in the sales process from preliminary discussions through close of project and beyond, maintaining momentum and clear communication throughout the sales cycle.
• Present the organization’s research capabilities and value proposition to customers and support customer meetings, capability presentations, and site visits as required.
• Build and maintain strong professional relationships with customer stakeholders at multiple organizational levels, demonstrating consistent professionalism, discretion, and reliability.