In Bayer’s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.

The Primary Responsibilities of this role, Specialist QC Chemistry are to:

• Perform and support testing to meet the laboratory TAT, (Turn Around Time) requirements.
• Partner with QC discrepancy team to investigate and identify corrective and preventative actions.
• Implement corrective and preventative actions.
• Assist in the development, revision, application, maintenance, validation, and review of quality standards, drafting SOPs, and methods for processing and/or ensuring quality in raw materials, intermediates, or finished products.
• Write and review Quality Control technical reports. Evaluate data/interprets trends.
• Write laboratory investigation protocols.
• Coach analysts and perform assay training.
• Perform complex equipment maintenance and troubleshooting.
• Participate during regulatory compliance audits and provide inspection related needs.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. More specifically, related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Knowledgeable with a cGMP and global regulatory compliance organization is required.
• Adaptable to changing business requirements in a dynamic corporate environment.
• Strong computer and communication skills are required.
• Write laboratory investigation protocols.
• Ability to partner cross functionally during discrepancy investigations.
• Experience with equipment and analytical method validation laboratory execution.
• Familiar with current regulatory requirements for validation.
• Effective Problem-Solving skills and ability to multitask.
• Prior experience in a QC laboratory and hands on experience with LIMS, SAP and related chromatographic software (EMPOWER).

Preferred Qualifications:

• Minimum of 6 years of industry experience or a master's degree with 2 years of industry experience or an equivalent combination of education and experience.,
• Chromatography, spectroscopy, and/or instrumental analysis background is desired.

Employees can expect to be paid a salary between $90,700 to $113,402.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

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