MSAT Intern

WuXi Biologics•Dundalk, MD

About The Position

MSAT Intern The MSAT Intern will support the MSAT team and gain hands-on experience in various aspects of the manufacturing process, including documentation, data analysis, technology transfer, validation activities, and continuous improvement initiatives. Working cross-functionally, the intern will assist with troubleshooting, process optimization, and ensuring compliance with safety and regulatory requirements while contributing to the success of MS&T projects. Organization Description: WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.

Requirements

Currently pursuing a bachelor’s or master’s degree in chemical engineering, Biochemical Engineering, Biotechnology, or a related field.
Strong academic performance with coursework relevant to bioprocessing and pharmaceutical manufacturing.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Understanding of bioprocessing principles, including upstream and downstream processing techniques.
Proficiency in data analysis tools and software commonly used in bioprocessing.
Ability to analyse complex data sets and draw meaningful conclusions.
Problem-solving skills with a focus on identifying and addressing root causes.
Excellent written and verbal communication skills.
Ability to articulate ideas and findings clearly and concisely.
Comfortable collaborating with cross-functional teams and presenting information to various stakeholders.
Demonstrated ability to work collaboratively in a team-oriented environment.
Willingness to contribute actively to team discussions and share insights.
Strong attention to detail, ensuring accuracy in data analysis and documentation.
Commitment to maintaining high-quality standards in all aspects of work.
Ability to adapt to a dynamic and fast-paced work environment.
Openness to learning new technologies and techniques in bioprocessing.

Nice To Haves

Familiarity with data analysis and visualization tools (e.g., MATLAB, R, Python) is a plus.
Familiarity with current Good Manufacturing Practices (cGMP) and regulatory requirements in the pharmaceutical industry.

Responsibilities

Assist in the creation, review, and revision of manufacturing batch records, standard operating procedures (SOPs), and other documentation.
Collaborate with the MS&T team to identify opportunities for process optimization and efficiency improvements in bioprocessing.
Collect and analyse data from manufacturing processes to identify trends, deviations, and areas for improvement.
Generate comprehensive reports summarizing key performance indicators (KPIs) and present findings to the MS&T team.
Support the technology transfer of new processes or modifications from development to manufacturing.
Work closely with cross-functional teams to ensure a seamless transition of processes into the production environment.
Assist in the execution and documentation of validation protocols for manufacturing processes and equipment.
Collaborate with the validation team to ensure compliance with regulatory requirements and industry standards.
Participate in investigations related to deviations, non-conformances, and out-of-specification results.
Work with the MS&T team to identify root causes and implement corrective and preventive actions (CAPAs).
Contribute to continuous improvement projects aimed at enhancing manufacturing processes, reducing costs, and increasing product quality.
Provide input and recommendations for the implementation of best practices in bioprocessing.
Work closely with research and development (R&D), quality assurance (QA), and production teams to foster effective communication and collaboration.
Participate in cross-functional meetings and provide input on process-related matters.
Engage in ongoing learning and development opportunities to enhance knowledge of bioprocessing technologies and industry trends.
Actively participate in training sessions and workshops offered by the MS&T department.
Assist in ensuring compliance with regulatory requirements, cGMP (current Good Manufacturing Practice), and other relevant standards.
Contribute to the preparation of documentation for regulatory submissions and inspections.
Adhere to safety protocols and guidelines in the manufacturing environment.
Contribute to initiatives promoting environmental sustainability and compliance with relevant environmental regulations.
Support project management activities, including timeline tracking, resource allocation, and milestone achievement.