Sr Manufacturing Scientist, Assembly & Packaging

<p><span><span>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.</span></span></p><p><span><span> </span></span></p><p><span><span>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.</span></span></p><p><span><span> </span></span></p><p><span><span>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.</span></span></p><p><b><u><span>Job Title</span></u></b><b><span>: Sr Manufacturing Scientist, Assembly &amp; Packaging</span></b></p><p><b><u><span>Location</span></u></b><b><span>: Uppsala, Sweden (on site)</span></b></p><p></p><p><b><u><span>Job description :</span></u></b></p><p>We are looking for a new member to the Assembly and Packaging team within Manufacturing Science and Technology. The senior manufacturing scientist is a subject matter expert (SME) responsible for new product implementation (NPI) into a manufacturing facility, and for support of assembly and packaging processes during commercial manufacturing. </p><p></p><p></p><p><b><u><span>Key responsibilities:</span></u></b></p><ul><li><p>Develop NPI strategy and support all aspects of process validation, including writing process validation documentation, executing process validation, performing process data reviews, investigations, risk management, and change implementation.</p></li><li><p>Serve as SME representing MS&amp;T in Technology Transfer projects.</p></li><li><p>Process owner to support day-to-day operations with a focus on continuous improvements. Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.</p></li><li><p>Lead and participate in investigations of deviations, incidents, and anomalies within the manufacturing process. Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement. Provide SME assessments in investigations and change controls as required. Prepare detailed investigation reports, conveying findings and recommendations to management and relevant stakeholders.</p></li><li><p>Collect and analyze data from various sources, including quality control reports, production logs, and other relevant documents, to support investigations and continuous process verification (CPV).</p></li><li><p>Develop and lead execution of technical runs with data analysis and recommendations.</p></li><li><p>Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards</p></li><li><p>Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed. </p></li><li><p>Coordinate and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Gather information to support research studies and claims, as well as perform risk assessments/FMEAs.</p></li></ul><p></p><p></p><p><b><u><span>Skills &amp; Qualifications </span></u></b></p><ul><li><p>Bachelor’s or master’s degree in a relevant scientific or engineering field</p></li><li><p>Minimum 6 years of experience in a biopharmaceutical or medical device downstream packaging manufacturing environment.</p></li><li><p>Knowledge of regulatory requirements related to investigations and cGMP</p></li><li><p>Strong knowledge of investigative methodologies and root cause analysis techniques.</p></li><li><p>Proficiency in data collection, analysis, and reporting</p></li></ul><p></p><p></p><p><b><u><span>What we offer in return</span></u></b></p><p>You will be wor