At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

rFVIIIManufacturing System Business Production Specialist 

Purpose:

The Production Specialist is responsible for business processes model management in the manufacturing of biotech and biological products including KG-PF and KG-N at the Berkeley Supply Center.

This is a hybrid office-based/work-from-home position within the United States. The employee may work remotely when consistent with business requirements but must be able to work at the Berkeley site to support key tasks/project execution as determined by the Company and business needs. The allocation between remote and on-site work may change over time and requires the ability to be present at the site with minimal notice.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role Manufacturing System Business Production Specialist are to:

• Analyze and evaluate interactions between potential causes, test results, process/equipment changes, and process variables to identify root cause and corrective/preventative actions;
•  Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement
•  Determine the breadth of discrepancies and insure appropriate Stakeholders in other organizations are made aware of a potential similar issue in their area;
•  Write concise, accurate and effective discrepancy reports that meet compliance expectations;
• Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition;
• Influence direction of investigations and communicate with all levels of employees;
• Use the Discrepancy Management system/database at an interim level to perform data entry and data-mining, in the support of both investigations and report-outs;
• Other related duties as assigned

WHO YOU ARE:

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree in a scientific or technical field, preferably biological sciences, engineering, etc.
• Previous experience working  relevant regulated cGMP pharmaceutical or biotech operations/manufacturing environment and experience in cell biology, tissue culture, Cell Culture experience,
• Understands business process management (BPM) principles and uses BPM effectively;
• Demonstrated ability to understand basic functionality of equipment / systems and supporting utility services;
•  Experienced in effectively training manufacturing personnel. Makes sense of and simplifies complex information providing clarity for others to get the job done;
• Excellent written and verbal communication skills, and ability to communicate with cross-functional partners to comply with requirements and meet production goals. Maintains open communication with customers and builds sustainable relationships
•  Excellent influencing skills;
•  Strong analytical skills to identify root causes and prepare balanced decisions;
• Applies team effectiveness skills and contributes actively to the achievement of department KPIs and objectives.
• Knowledge/experience of MS Office Suite (Outlook, Project, Excel, etc), SAP, ValGenesis.
• Build partnerships internally and externally. Leverages expertise and talents across functions and divisions.

Preferred Qualifications:

• Bachelor Degree with 6 years + of experience or Master’s degree with 4+ yrs, or An equivalent combination of education and experience
• Strong knowledge of SAP and ValGensis
• Experience in cGMP and regulatory requirements (FDA, EMA, ICH, etc.) for pharmaceutical manufacturing;

Employees can expect to be paid a salary of between $990000 - 148500.00. 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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