Drug Product Scientist (MSAT)

Rensselaer, NY, United States
Mar 03, 2021
Required Education
Position Type
Full time
We are currently looking to fill a Drug Product Scientist position within our Drug Product Manufacturing Science and Technology team. This position will serve as a specialist in equipment selection and qualification, process and product optimization, and will be hands-on during technology transfer and cGMP start-up activities. This team will strive to establish standard methodologies for technical support and product lifecycle management of cGMP manufacturing operations. The position will also focus on ensuring site to site consistency after the processes are optimally transferred.

In this role, a typical day might include the following:
• Lead or support technology transfer activities, including performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review of production Master Batch Records.
• Collaborate in cross-functional teams to ensure timely delivery of tasks.
• Lead the design and execution of small-scale DOE studies to support the development and optimization of robust fill/finish processes with efficient product quality and stability.
• Provide technical support to execution of new GMP processes and critical unit operations. Contribute scientifically to Deviation Investigations, Corrective Action Prevention Plans (CAPAs), and Change Controls.
• Generate technology transfer documents, perform process monitoring, author campaign summary reports and recommend improvements for MSAT procedures.
• Scientifically support commercial drug products, including design changes and continuous improvement projects.
• Act as a technical specialist within the MSAT group as well as for the various project teams, delivering scientific or technical mentorship and leadership to Engineers and Specialists to enable them to effectively meet their project objectives. May supervise others depending on experience and business need.
• Provide scientific expertise in process equipment and qualifications in start-up of new manufacturing sites. Introduce new technology solutions for process robustness and adapt processes and equipment to manufacture drug product of new biopharmaceutical classes.
• Represent technical transfer technology topics in cross-functional development teams, ensuring the provision of appropriate data and developing of technical communities.
• Works with Global Analytical and Process Development to build the scientific knowledge, capabilities, and technical strategies in biopharmaceutical raw materials, product and process characterization that enable rapid and robust product development, clinical introduction and commercialization.
• Provide scientific support to associates for process validation and commercial stage products including leading all aspects of execution of GMP studies, investigation and data analysis of results, and writing/review of associated technical reports.

This role might be for you if you:
• Have experience with monoclonal antibodies, gene therapies and antibody-drug conjugates
• Have experience interacting with Contract Manufacturing Organizations
• Continuously seek to improve processes for improved performance
• Are OK with travel, domestic and international, up to 50% of the time

To be considered for this role you must hold a PhD in (bio)chemical engineering, biomedical engineering, biochemistry or chemistry and 3+ years of broad research experience, preferably in the biopharmaceutical, pharmaceutical or chemical industry preferred. A PhD in another related field may be considered. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.