In this role, you will drive the digital transformation of the lab operations, ensuring seamless integration of LIMS/ELN into workflows. You will work closely with scientists, researchers, and technical teams to optimize processes, enhance data management, and deliver robust digital solutions that support research and development. These tasks are waiting for you: Identify requirements for enhancing digital laboratory workflows by interacting with different stakeholders (researchers, scientists, etc.)Analyze and adjust lab processes to maintain efficiency and enable seamless transitions when implementing changesDevelop and manage interfaces between the ELN and internal systems, such as master data repositories, lab equipment connections, and data storage platformsSupport the adoption of FAIR principles in scientific data management to ensure data quality and accessibilityInnovate and implement system improvements, including upgrades and extensionsProvide project-based supportDeliver technical support to users, resolve system issues, and coordinate vendor interactions for advanced troubleshooting Details about the workplace:Type of contract: indefinite + full timeVacation: 30 days / yearWorking hours: 40 hours / weekAn opportunity to lead the digital transformation of laboratory operationsA collaborative and inclusive work environment with a diverse team of experts This completes your profile:University degree in computer science, information technology, or a related field, or equivalent qualification3+ years of extensive experience with LIMS/ELN and strong understanding of laboratory workflows and data management in scientific environmentsProfound knowledge in Database management (e.g., SQL, Python, or similar)Effective communicator with a strong hands-on mentalityFluent in English; intermediate German skills are preferred Information about our client: Our client is a global clinical-stage biopharmaceutical company that discovers and develops drugs. With their innovation-driven team, the company focuses on vaccines, innovative cancer immunotherapies and protein-based therapies.

Job Title:Senior Director, Quality Operations (EMEA) Location:UK Based - Hybrid Working Model About the Role:A global pharmaceutical company is seeking a Senior Director, Quality Operations to lead quality assurance and control across EMEA operations and API manufacturing. This is a critical leadership position, ensuring the highest standards of product safety, efficacy, and compliance throughout the supply chain. Key Responsibilities:Strategic Leadership:Develop and execute the quality strategy for EMEA operations and API manufacturing to align with organizational goals.Lead initiatives to enhance quality systems, processes, and organizational culture.Regulatory Compliance:Ensure adherence to GMP, FDA, EMA, ICH, and other international regulatory standards.Lead preparation for and management of regulatory authority inspections and audits.Operational Oversight:Manage quality operations for API manufacturing, implementing robust quality assurance and control frameworks.Proactively identify and mitigate quality-related risks across the supply chain.Team Leadership:Build, lead, and mentor a high-performing team of quality professionals across multiple locations.Drive a culture of accountability and excellence within the quality organization.Cross-Functional Collaboration:Work closely with internal teams, including R&D, Supply Chain, Regulatory Affairs, and Manufacturing, to integrate quality standards throughout the product lifecycle.Collaborate with external partners, such as API suppliers and contract manufacturers, to maintain quality standards.Performance Monitoring:Define and monitor key quality metrics to ensure continuous improvement.Provide regular quality performance updates and risk assessments to senior leadership.Qualifications & Experience:10+ years of progressive experience in quality assurance/control within pharmaceutical or biopharma industries.Strong knowledge of GMP regulations and quality systems, with a focus on API manufacturing and international operations.Proven experience leading teams across multiple geographies and managing complex quality challenges.Exceptional problem-solving skills and the ability to drive continuous improvement initiatives.Outstanding communication and stakeholder management abilities.What's on Offer:This role offers the opportunity to play a pivotal role in ensuring the quality and compliance of life-changing pharmaceutical products. You will have the chance to lead and shape the quality strategy for a globally impactful organisation. How to Apply:To express your interest in this confidential opportunity, please submit your CV and a cover letter outlining your experience and suitability for the role

Overview:SciPro are currently supporting a global leader dedicated to transforming addiction from a human crisis to a recognised and treated chronic condition. With a vision to ensure worldwide access to evidence-based treatments for substance use disorders (SUD) and associated co-occurring conditions, this organisation focuses on expanding access to quality care. Leveraging a strong portfolio of opioid use disorder treatments and an innovative pipeline.Position Summary:The Scientific Writer will work within the R&D Chemistry, Manufacturing, and Controls (CMC) team, specialising in Module 3 Dossier Development. The role involves drafting, reviewing, and approving regulatory documents to support the development and maintenance of new and existing dossiers from Phase 1 through post-approval.Essential Functions:Develop and maintain Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF, and DMF), including Module 2.3 QOS, for drug substance and drug product.Author, review, and approve regulatory submission documents and prepare responses to Health Authority queries.Support CMC-related regulatory changes in response to new intelligence.Manage CMC aspects of change control for existing licenses.Drive project milestones, ensuring timely delivery.Maintain expertise in ICH guidelines, EMA/FDA guidance, and local regulations, applying them across all activities.Contribute to Module 3 strategy meetings, risk assessments, and stakeholder interactions by leveraging regulatory and technical expertise.Collaborate with external partners, global regulatory teams, QA, supply chain, and other stakeholders to deliver Module 3 documentation.Promote continuous improvement of CMC functions by integrating new technologies and processes.Minimum Qualifications:Education: Bachelor's degree or higher in Chemistry or a relevant scientific discipline.Industry Experience: 5-10+ years of experience in scientific writing and/or reviewing Module 3 dossiers in CTD format.Technical Skills: Proficiency in Microsoft Office applications (Word, Outlook, PowerPoint, Excel).Competencies:Strong problem-solving and technical troubleshooting skills.Ability to think critically and offer novel solutions to challenges.Proven experience working in fast-paced, cross-functional environments.Preferred Qualifications:A 2:1 or first-class degree.Knowledge of drug substance requirements, such as ASMF/DMF.Familiarity with global regulatory requirements (e.g., US, Europe, Canada).Experience with document management systems like Veeva or D2.

SciPro is currently partnered with a clinical-stage biotechnology company targeting novel drug delivery platforms. The company is looking for a formulation subject matter expert to join the Technical Operations team and lead all drug product development strategy.   Responsibilities: Lead a small team of formulation scientists working inhalation drug delivery platforms Oversee raw material development and preformulation through late-stage process development Coordinate with other cross functional CMC teams   Qualifications: PhD in Biochemistry, Chemical Engineering, or related field with ideally 12+ years of industry experience (combined experience in biotech and pharmaceutical environment is ideal) Hands on experience working with inhalable drug delivery formats People leadership experience strongly preferred   All interested applicants are encouraged to apply below.

Engineering / Capital Project Manager Raleigh NC   PROFILE:   This individual will develop, implement, and oversee capital projects and equipment purchases to support biopharmaceutical Operations. This role is focused on managing projects ranging in size of up to $5 million. Duties include interfacing with cross-functionally with both internal teams and groups, and external suppliers to ensure projects are delivered on time and within budget. This position will utilize breadth of knowledge across facilities and engineering to ensure regulatory compliance and effective project execution   REQUIRED COMPETENCIES   Strong pharmaceutical project management skills and proven experience in having managed capital projects with emphasis on Biologics, clinical and/or manufacturing and development laboratories in a cGMP environment. Project Management skills including the development and management of work breakdown structures, RACI diagrams, schedules, budgets, action trackers and meeting minutes. Understanding of GMP, regulatory, environmental, and OSHA regulations as it relates to Engineering, Facilities Operations and Construction Understanding of financial management as it relates to capital and expense spending and project cash flow forecasting. (i.e. Purchase Orders, Invoicing) Experience in total project delivery in a cGMP environment (from concept to validation and startup process). Leads the development of the capital project scope and objectives in support of the business strategy dealing with clients and stakeholders. Exhibits project leadership and effective decision making throughout each project. Leads and promotes effective teamwork by engaging both Facilities as well as including key clients and stakeholders.   QUALIFICATIONS & EXPERIENCE:   BSc in Engineering or equialvent discipline Previous cGMP Project Management experience Right to work in the USA without Sponsorship