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Sr. Associate Production Scientist
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The cGMP Senior Associate Production Scientist is an experienced individual responsible for the manufacture of Active Pharmaceutical Ingredients (APIs) and excipients regulated by the Food and Drug Administration. They are responsible for following manufacturing protocols consistent with current Good Manufacturing Practices (cGMP) and ensuring the accuracy of documentation. They will be a technical leader assisting in the Manufacturing GMP Readiness efforts and be responsible for authoring/editing procedures used to manufacture product.
Essential Job Functions:
- Author change control documentation for new and legacy APIs and excipients.
- Assist with the transfer of information from the manufacturing technical SMEs to the on-the-floor manufacturing personnel.
- Provide technical support, according to established protocols, and assist in the performance of operations in support of the group and department.
- Ensure quality throughout the process.
- Author/edit operating procedures and batch protocols.
- Train personnel and act as a technical consultant as needed.
- In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles.
- Interface with external customers
- Communicate the status of operations and bring deviations to the attention of supervisor.
- Interact with other departments as needed.
- Participate as needed in quality audits.
Who You Are:
- Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Biology, or other life science field
- 1+ years of experience in an GMP environment
- Proven prior experience in a technical document writer position specifically in the GMP/Biotech/Pharma/Regulated Industry
- Demonstrated experience in detailed review work and following procedures, especially in a GMP regulated industry.
- Familiarity with FDA, EMA, and other regulatory standards
- Independent, self-starter with proven results in biopharmaceutical manufacturing operations
- Demonstrated ability to work effectively cross-functionally.
- Interpersonal and team-building skills
- Very strong attention to detail
- Excellent oral and written communication skills
- Good evaluation and analytic skills for problem identification and communication to others
- Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a windows-based environment.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html