Process Development Engineer, Sr Process Development Engineer I
Bayer (Oakland/East Bay, California)

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Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.

Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Hematology/Cardiology business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.

POSITION DESCRIPTION
The candidate will work in a leadership function to plan and carry out
scientific/engineering and technical projects in order to evaluate, develop and
scale-up processes. Position will involve evaluation and implementation of technologies in Aseptic Processing, Formulation, Filling, Freeze-Drying, and Packaging.

The candidate will be responsible for developing and managing timelines, assessing technical feasibility of project options, and executing implementation plans. The individual will be responsible for technical transfer of biopharmaceutical fill/finish and packaging processes for commercial production. He/she will contribute to technical support for process/equipment validation and will identify and implement new technologies to continuously improve processes. His/her responsibility will include to lead or support root cause analysis investigations and to recommend corrective actions and preventative actions (CAPA). The individual will provide technical input to support process changes, regulatory submissions and agency inquiries, and product complaints and inquiries. This position may have other duties and responsibilities to support business needs.

POSITION REQUIREMENTS
BS 8+ years
MS 6+ years
PhD 0-5 years
Professional registration and/or certifications as appropriate.

Engineering degree with relevant experience in a relevant discipline: Chemical
Engineering, Biomedical Engineering, Industrial Engineering, etc., plus
production and/or engineering experience in the biopharmaceutical industry

Supervises scientific personnel and contributes to research projects,
technologies, intellectual property, or trade secrets.
Interacts regularly with senior technical peers and colleagues.
Sets levels of technical and/or regulatory performance for others at Bayer to
emulate.
Develops network of external contacts appropriate to job.
Performs assignments in more than one location.
Creates an environment that encourages problem-solving at the individual and
team level. .