Sr. Scientist, New Products
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Manufacturing Science & Technology
Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Our Bedford, OH facility is seeking a Sr. Scientist, New Products that is esponsible for technical evaluation of new products being introduced to the Cleveland manufacturing facility. Serves as subject matter expert for process development and transfer activities.
Key Responsibilities
- Create technical documents outlining process requirements for new products and author protocols and reports for development batches.
- Create process risk assessments linking critical process parameters and critical quality attributes to process design and provide recommendations process implementation on the equipment at the Cleveland Manufacturing facility.
- Utilize effective communication strategies to serve as the product technical lead during transfers, ensuring project progress and success through collaborative interactions and planning.
- Provide technical leadership on investigations, including justification statements, to close out activities related to the product processes prior to exhibit batch production.
- Develop effective data analysis methodologies, including statistical process controls and sampling plans to assist in ensuring manufacturing success and audit justifications onsite.
- Responsible for outlining studies required for the new Cleveland products, inclusive of extractable/leachable studies, filter validation, etc.
- Assist in writing site Master Batch Records and Standard Operating procedures as required for new product manufacturing.
- Ensure assigned tasks are completed in a timely fashion and communicated effectively to MS&T management
- Oversee that processes implemented for new products are CGMP compliant, help identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness and heighten quality.
- Demonstrate proficient knowledge of the manufacturing process and site procedures
- Contribute to site regulatory activities, including audits, inspections and submission documentation
- Demonstrate the ability to read, comprehend and execute Standard Operating Procedures (SOP) and instruction documents.
- Be self-motivated, methodical and capable of managing multiple stakeholders with an acute awareness of the direct and indirect impact of all actions performed.
- Communicate effectively in both verbal discussion and written text
- Ensure appropriate clean and protective apparel is worn when engaging in activities involving drug product to protect from contamination.
Experience and Skills
- Bachelor’s Degree in Science/Engineering
- 4+ years of experience in pharmaceuticals, inclusive of project team leadership activities for process and/or equipment validation. Experience participating in process or method transfers preferred.
- Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211,CGMP’s, FDA, OSHA and other regulatory agencies.
- Knowledge of validation principles and experience executing validation activities for equipment and process.
- Must have the knowledge and phase appropriate implementation strategies of QbD during Life-cycle management of the product.
- Experience writing CMC section of regulatory filings preferred.
- Understanding of LEAN manufacturing principles.
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
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Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
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