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. Product Specialist II Cell Therapy Drug Product Focuses on setting up, operating, maintaining, and troubleshooting manufacturing production that include isolators, aseptic filling equipment, mixers, pumps, biosafety cabinets, glove integrity testers, environmental monitoring equipment, etc. Cleans and decontaminate equipment. Maintains housekeeping of the workplace. Prepare media and solutions to support the cell therapy process. Performs visual inspection of drug product vials. Conducts routine analytics and takes samples. Coordinates equipment maintenance and repairs with the technical team. Documents and communicate work results during shift handovers. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Product Specialist II Cell Therapy Drug Product, are: <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Works with a single-cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single-use technology. Manufactures products in various phases of product life cycles from clinical through launch. Responsible for all aspects of clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure all activities are performed to schedule. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Authors, redlines, and reviews-controlled documents for various equipment/processes. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Monitors and controls processes using data trending and/or statistical process control. Work cross-functionally to ensure process is controlled and issues are escalated and investigated.</li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Raises and supports investigation of deviations. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Partners cross- functionally to determine product impact and root cause. Implements and executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence. Participate in regulatory and internal audits. Supports commissioning and qualification of equipment.</li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Participates in safety investigations for CT-MOD and always promotes safe behaviors. Partners cross-functionally to identify and implement corrective actions. </li> </ul> WHO YOU ARE Bayer seeks an incumbent who possesses the following: Required Qualifications: <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience.</li> </ul> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Experienced with Lean manufacturing principles.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Experienced with business IT systems.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Excellent computer skills; experienced with Microsoft Office Suite of tools (Work, Excel, PowerPoint, Access, etc.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ability to lift 45 lbs. </li> </ul> Preferred Qualifications: <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Bachelor’s Degree in a science related field Minimum Experience: BS +2 years, or MS +1 years of related experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience. </li> <li style="margin:0.0in 0.0in 0.0in 48.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Computer programming or automation support</li> </ul> Employees can expect to be paid a salary of between $64,000.00 – $97,000.00. 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. This posting will be available for application until at least: 4/30/2026. <table style="width:970.0px" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4">YOUR APPLICATION</td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> </tbody> </table> <table style="width:970.0px;height:399.25px" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height:212.125px"> <td style="text-align:justify;vertical-align:top" colspan="4"> Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="text-align:justify;vertical-align:top" colspan="4">Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.</td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="text-align:justify;vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="text-align:justify;vertical-align:top" colspan="4">Bayer is an E-Verify Employer.</td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="text-align:justify;vertical-align:top" colspan="4"> </td> <td> </td> </tr> <tr style="height:23.3906px"> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="vertical-align:top;width:150.0px">Location:</td> <td style="vertical-align:top;width:200.0px" colspan="3">United States : California : Berkeley </td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="vertical-align:top;width:150.0px">Division:</td> <td style="vertical-align:top;width:150.0px" colspan="3">Pharmaceuticals </td> <td style="vertical-align:top"> </td> </tr> <tr style="height:23.3906px"> <td style="vertical-align:top;width:150.0px">Reference Code:</td> <td style="vertical-align:top;width:150.0px" colspan="2">866645 </td> <td style="vertical-align:top"> </td> <td style="vertical-align:top"> </td> </tr> </tbody> </table> <table style="width:970.0px" border="0" cellspacing="1" cellpadding="1" align="left"> <tbody> <tr> <td colspan="3"> </td> </tr> <tr> <td colspan="3"> </td> </tr> <tr> <td colspan="3">Contact Us</td> </tr> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top;width:150.0px">Email:</td> <td style="vertical-align:top;width:150.0px" colspan="2" rowspan="1">[email protected] </td> </tr> </tbody> </table>

Product Specialist II Cell Therapy Drug Product (Berkeley, California, US) @ Bayer

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