(Sr.) CSV Manager (m/f/x) | Mainz Area | Pharma

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 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.

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

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.