Process and Analytical Technology Transfer Lead

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Process and Analytical Technology Transfer Lead

Location: Boston, MA

Job Description:

The Process and Analytical Technology Transfer Lead will lead and support the transfer of drug substance, drug product, and/or medical device processes and QC analytical methods into commercial manufacturing facilities.  Customers may be internal or external partners, and the transfer may exist from clinical production through process performance qualification and commercial operations.   

Key Responsibilities:

• Site representation in global technology transfer process.
• Subject matter expert (SME) for Technology Transfer and Analytical Method Validation
• Implement programs for smooth transition of analytical methods into full production readiness, representing MS&T in Tech Transfer projects.
• Collaborate with the team to ensure that method transfer optimizes the process in terms of efficiency, cycle time, reliability, and serviceability.
• Process Technical Transfer: Lead and support cross-functional tech transfer for upstream and downstream processes.  Generate and review tech transfer documentation, such as tech transfer plan, gap/risk assessments and validation plans/protocols.  Serve as subject matter expert on process and provide technical oversight at receiving manufacturing site. 
• Analytical Method Transfer Management: Lead and coordinate the end-to-end process of transferring analytical methods from either internal production or across external sites. Develop and support analytical method tech transfer and execution, including method verification, transfer and validation.  Identify analytical needs and perform risk and gap assessments.  Collaborate cross functionally with product sciences, quality control, and quality teams to ensure the robustness of new technologies. Ensures all deliverables are in place prior to each project milestone.
• Project Management: Create detailed project plans and timelines for tech transfer activities and communicate progress to stakeholders. Track project deliverables, identify and address roadblocks, and ensure all actions are completed on time.
• Documentation & Compliance: Serve as SME to review, author and deliver SOPs, transfer plans, protocols, reports and transfer summary reports.  Ensure compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA). Support regulatory requests and inspections.
• Cross-Functional Collaboration: Coordinating subject matter experts within Product Sciences, Quality Control, MS&T, Quality and Regulatory Affairs and other site related functions or experts, to ensure that requirements are met.  Support best practices for tech transfer and method validation as required.
• Troubleshooting & Problem Solving: Identify potential risks in the method transfer process and develop mitigation strategies. Support the QC team to investigate any project challenges with appropriate risk assessment tools. 
• Training & Support: Ensure that receiving sites are adequately trained on new methods or technologies.  Provide technical expertise and leadership to teams throughou