reputed company Full Stack Manufacturing Scientist – Biopharmaceutical Production and Quality Assurance (Third Shift)

Are you a highly motivated and detail-oriented Manufacturing Scientist looking for a challenging role in a dynamic biopharmaceutical company? Do you have a passion for driving quality and process excellence in a fast-paced environment? We are seeking an reputed company Manufacturing Scientist to join reputed company on the third shift, working closely with our cross-functional teams to support the production of high-quality biologics.

About Our Company

Our partner company is a leading biopharmaceutical organization that has achieved significant milestones, including two FDA approvals. As they transition from R&D to commercial-scale production, they are building a new state-of-the-art facility to support their growth. This is an exciting opportunity to join a company that is pushing the boundaries of biologics manufacturing and is committed to delivering innovative solutions to patients worldwide.

Job Summary

We are seeking a highly skilled Manufacturing Scientist to join reputed company on the third shift, Monday to Friday from 22:00 to 06:00am. As a Manufacturing Scientist, you will be responsible for participating in cGMP manufacturing processes, technology transfer, and authoring/revising documents to support batch records. You will also prepare production systems, buffers, and media for use in the production area.

Responsibilities

As a Manufacturing Scientist, your key responsibilities will include:

• Writing and reviewing Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements
• Providing support to the Quality and Compliance Departments during regulatory audits, ensuring seamless communication and collaboration
• Accomplishing small projects independently and providing substantial assistance to large projects, demonstrating your ability to work effectively in a team environment
• Monitoring bioreactor operation (70% of the total night shift), ensuring optimal process conditions and product quality
• Supporting media or buffer preparation, reputed company process (cleaning of column, sampling, etc.), and logbook verification and document review
• Participating in the cleaning activities of routine items as per cleaning validation program, ensuring a clean and safe working environment
• Compiling process data, performing pH/conductivity reputed company, osmometer, and scale calibration/verification, and maintaining accurate records
• Collaborating with cross-functional teams to resolve issues and improve processes, driving quality and efficiency

Essential Qualifications

To be successful in this role, you will need:

• A Master's or Bachelor's degree in Chemistry, Biology, Biochemistry, or a reputed company field
• Relevant experience in a biopharmaceutical organization, with a minimum of 2 years of experience in biologics manufacturing
• Experience and knowledge in drug substance manufacturing (Fermentation and protein purification) and in drug product manufacturing (aseptic processing areas)
• Upstream or reputed company background, with a strong understanding of biologics manufacturing processes
• Excellent communication and collaboration skills, with the ability to work effectively in a team environment

Preferred Qualifications

While not essential, the following qualifications would be highly desirable:

• Experience with cGMP manufacturing processes and regulatory requirements
• Knowledge of biologics manufacturing equipment and systems
• Familiarity with quality management systems and regulatory compliance
• Strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues
• Experience with data compilation and record-keeping

Skills and Competencies

To succeed in this role, you will need to demonstrate the following skills and competencies:

• Strong attention to detail and organizational skills, with the ability to prioritize tasks and manage multiple projects
• Excellent communication and collaboration skills, with the ability to work effectively in a team environment
• Strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues
• Ability to work independently and as part of a team, with a strong sense of accountability and responsibility
• Strong knowledge of biologics manufacturing processes and regulatory requirements
• Familiarity with quality management systems and regulatory compliance

Career Growth Opportunities and Learning Benefits

As a Manufacturing Scientist with our partner company, you will have the opportunity to:

• Work with a dynamic and reputed company team of professionals in the biopharmaceutical industry
• reputed company your skills and knowledge in biologics manufacturing, quality assurance, and regulatory compliance
• Participate in training and development programs to enhance your career prospects
• Collaborate with cross-functional teams to drive quality and process excellence
• Contribute to the development of new products and processes, driving innovation and growth

Work Environment and Company Culture

Our partner company is committed to creating a positive and inclusive work environment that supports the well-being and success of its employees. As a Manufacturing Scientist, you will have the opportunity to work in a state-of-the-art facility, with access to the latest equipment and technology. You will also be part of a dynamic and reputed company team of professionals who are passionate about delivering high-quality products and services.

Compensation, Perks, and Benefits

We offer a competitive salary and benefits package, including:

• A comprehensive health insurance plan
• A 401(k) retirement savings plan
• Paid time off and holidays
• Opportunities for professional development and career growth
• A dynamic and inclusive work environment that supports the well-being and success of its employees

Conclusion

If you are a highly motivated and detail-oriented Manufacturing Scientist looking for a challenging role in a dynamic biopharmaceutical company, we encourage you to apply for this exciting opportunity. As a Manufacturing Scientist with our partner company, you will have the opportunity to work with a dynamic and reputed company team of professionals, reputed company your skills and knowledge in biologics manufacturing, quality assurance, and regulatory compliance, and contribute to the development of new products and processes. Don't hesitate to apply – we look reputed company to hearing from you! Apply for this job