We are seeking an enthusiastic and talented team player to join a growing Product Development Department as a Product Development Manager, Commercial. This role involves providing technical and analytical knowledge of commercial products and leading projects in their commercial phase. You will take ownership of driving projects to ensure robustness in commercial products. This exciting opportunity spans different therapeutic areas, including metabolic, immunology, and neurology, involving various technologies and dosage forms. You will build your internal network and contribute to cross-functional project teams. By participating in company projects, you will leverage your skills to support growth plans and the patients served. Job Interactions & InterfaceThis role interacts with internal teams such as Product Managers, Project Management Operations (PMO), Regulatory Affairs, Quality, and Supply Chain. Externally, it engages with Contract Manufacturing Organisations (CMOs), suppliers, and third-party vendors.The team is small but dynamic, reflecting an expanding company that requires an adaptive and pragmatic mindset. Coaching and mentoring tailored to individual needs will support continuous learning and professional development. Position SummaryThis is a full-time position within the Product Development department, based in Cambridge. What You Will Be DoingTechnical Responsibilities:Provide formulation and analytical technical expertise to support commercial products, collaborating with Product Management, Quality, and Regulatory Affairs teams.Build and maintain strong relationships with third-party vendors.Support commercial manufacture and lead trending of product performance.Investigate issues and risks, design scopes of work, and manage execution of projects with CMOs.Maintain knowledge of relevant regulatory guidance, particularly US-FDA-focused.Execute assigned tasks following SOPs and suggest process improvements.Prepare and review technical documentation and contribute ideas in discussions.Departmental Responsibilities:Contribute to the annual budget and operational planning.Represent the department on cross-functional project teams.Act as a role model, demonstrating focus, flexibility, and creativity.Provide training and development for stakeholders.Improve departmental procedures and processes for efficiency and consistency.Provide cover for the Product Development team during absences.What Will Enable You to ThriveEssential:Degree or equivalent in a science field (higher degree preferred).Experience in drug product formulation development, particularly oral solid dose forms or solutions and suspensions.Familiarity with ICH guidelines.Excellent communication and project management skills.Strong analytical, problem-solving, and negotiation skills.Ability to work autonomously or as part of a team, with a proactive and results-oriented approach.Desirable:At least five years' experience in areas like analytical method development, technical transfer, vendor management, or API development.

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.

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