Sr Manufacturing Scientist Device Injectables
Sr Manufacturing Scientist Device Injectables
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Job Description
Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing 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 bodys 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: Sr Manufacturing Scientist Device Injectables
Location: Uppsala Sweden (on site)
Job description :
We are looking for a new member to the Device Injectables 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 upstream processes during commercial manufacturing.
Key responsibilities:
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.
Serve as SME representing MS&T in Technology Transfer projects.
Process owner to support daytoday operations with a focus on continuous improvements. Identify opportunities for process enhancement cost reduction and efficiency gains proactively driving necessary changes.
Lead and participate in investigations of deviations incidents and anomalies within the manufacturing process. Conduct indepth 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.
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).
Develop and lead of technical runs with DoE studies data analysis and recommendations.
Maintain comprehensive records of investigations findings actions taken and recommendations ensuring compliance with regulatory and quality standards
Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.
Coordinate and collaborate with crossfunctional 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.
Skills & Qualifications
Bachelors or masters degree in a relevant scientific or engineering field
Minimum 6 years of experience in a biopharmaceutical or medical device upstream manufacturing environment preferably with sterilization knowledge
Knowledge of regulatory requirements related to investigations and cGMP
Strong knowledge of investigative methodologies and root cause analysis techniques.
Proficiency in data collection analysis and reporting
What we offer in return
You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
As Galdermas Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane Azzalure and Sculptra.
We are offering you the opportunity to work in an exciting international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisn) in Uppsala only a 10 minute bike ride from Uppsala Central Station.
Next steps
We welcome your application via our company website CAREERS Galderma. Apply as soon as possible as the selection process is ongoing.
If your profile is a match we will invite you for a first virtual conversation with the recruiter.
The next step is an interview with the hiring manager
The final step is a panel conversation with the extended team
Our people make a difference
At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do.
Required Experience:
Senior IC
Employment Type
Full Time
