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.

(Sr.) CSV Manager (m/f/x) | Mainz Area | PharmaJoin a trusted and innovative pharmaceutical company as a key expert (m/f/x) in computer system validation. Your expertise will guide essential validation processes, and you'll engage in exciting projects that make a real difference in advancing healthcare solutions. These tasks are waiting for you: Planning, coordination, and execution of computer system validation in compliance with current regulationsEnsuring regulatory compliance throughout all stages of computer system validationConducting risk management within the scope of computer system validation (CSV)Managing all documentation generated during validation projectsPreparing final validation reports and ensuring data and system securityPlanning, supervising, and monitoring validation, qualification, and calibration activitiesCoordinating and overseeing deviation managementPreparing and reviewing GMP-related documentationSupport in external auditsThis completes your profile:Degree in Computer Sciences or comparable qualifications with relevant work experience4+ years of professional experience in a CSV role, preferably in the pharmaceutical industry or medical device industryIn-depth knowledge of regulatory requirements (GxP, CFR 21 Part 11/EU GMP Annex 11, GAMP5)Excellent communication skills and a methodical, quality-focused approach to workFluency in both German and EnglishBenefits:Flexible working hours with 30 days of holidayPersonal and professional developmentHealth offers such as JobRad, Wellpass, and sports groupsCollaborative and appreciative work environment, with flat hierarchies Information about our client: Our client is a well-established company in the pharmaceutical industry, offering end-to-end services across drug development, manufacturing, and supply chain management. Known for quality and innovation, the company provides a collaborative work environment focused on efficiency and quick decision-making, supported by a close-knit, professional culture.

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 contribute to formulation development, scale-up, and tech transfer activities.   Responsibilities: Formulate novel inhalation drug delivery platforms Manage raw material development and preformulation through late-stage process development Process design and development for drug product manufacturing Coordinate with other cross functional CMC teams   Qualifications: PhD in Biochemistry, Chemical Engineering, or related field with ideally 3+ years of industry experience (combined experience in biotech and pharmaceutical environment is ideal) Hands on experience working with inhalable drug delivery formats   All interested applicants are encouraged to apply below.

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.

Senior Validation Engineer (Contract) Location: Van Nuys Area Role Overview We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documentation and validation tasks for automation projects. You'll also draft design specifications, conduct validation testing, and collaborate with various internal departments and external vendors to ensure smooth project execution. Key Responsibilities Draft and review documentation, including user requirements, design specifications, and testing protocols. Conduct hands-on validation for automation projects and address protocol discrepancies. Work with internal departments and external vendors to establish schedules and coordinate validation activities. Attend project meetings and communicate status updates to relevant stakeholders. Perform project management tasks and escalate issues to leadership as needed. Qualifications Bachelor's Degree and a minimum of 5 years of experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, or cell therapy industries. Strong knowledge of equipment and computerized systems, with an understanding of data integrity and change control management. Excellent interpersonal and technical writing skills. Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems is preferred. Proficiency in Microsoft Office tools, including PowerPoint, MS Project, Excel, and Word. Ability to work collaboratively across departments and with external vendors.