Number of Applicants
:000+
Job Title: Senior Scientist
Full time: On site
Location: Gaithersburg, Maryland, United States of America
Salary: $138,000 - £145,000
Job Description
Our clients Gaithersburg, Maryland facility crafts life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, they play host to some of the most cutting-edge technology and lab spaces, all designed to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center. This is where you’ll find newly designed, activity-based workspaces to suit a variety of working styles while growing collaboration between teams.
Role:
The position resides within the Cell Culture and Fermentation Sciences (CCFS) department within Biopharmaceutical Development (BPD). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial upstream processes to GMP manufacturing production.
Main Duties & Responsibilities:
• Routinely transfer multiple projects as upstream tech transfer representative. This includes fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and management
• Builds and maintains relationships with partner groups
• Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
• Effectively communicate and collaborate in a matrix team setting to implement technical solutions
• Write technical reports and deliver presentations
• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities
Education & Experience Requirements:
A Bachelors or master’s degree in an engineering or scientific discipline. A focus in a process engineering field (e.g., chemical, or biochemical engineering) is strongly preferred.
Relevant industry related experience (BS 10-13, MS 8-10).
Essential Skills:
• Cell culture tech transfer and/or development experience.
• Hands on experience with bioreactors (bench, pilot, or production scale)
• Fundamental understanding of upstream unit operations such as mixing, inoculum expansion, bioreactor, centrifugation, and filtration.
• Knowledge of GMP manufacturing principles and documentation.
• Experience with data and statistical analysis.
Desired Skills:
• Experience with primary clarification via continuous centrifuge
• Identify and solve complex manufacturing or bioprocess technical problems with limited data in a timely manner
• Proven ability to defend a technical position
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Fermentation or viral based production experience
• Skilled in conducting process transfer/process development/technology development projects
Position requires periodic weekend work (cell culture) and/or periodic late-night calls (manufacturing support or international collaborations). Position will require some travel to CMO or other sites (domestic and international).
Essential Requirements:
• Cell culture tech transfer and/or development experience
• Hands on experience with bioreactors (bench, pilot, or production scale)
• Fundamental understanding of upstream unit operations such as mixing, inoculum expansion, bioreactor, centrifugation, and filtration.
• Knowledge of GMP manufacturing principles and documentation
• Experience with data and statistical analysis
Desired Requirements:
• Experience with primary clarification via continuous centrifuge
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Fermentation or viral based production experience
• Skilled in conducting process transfer/process development/technology development projects
If you requirement any reasonable adjustments throughout your recruitment journey please get let our team know so we can support you!
Get in touch with Amber Bouvet at View email address on jobs.institutedata.com for more detail.
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