Job Description

**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.** **Sr. Production Technician Operations II - Kovaltry/Jivi-API rFVIII** **Sr. Production Technician Operations II - Kovaltry/Jivi-API rFVIII** **PURPOSE** Support in the manufacture of Bayer's rFactor VIII products (Kovaltry and Jivi) by performing daily cell culture and purification operations in accordance to cGMP and safety regulations to minimize any loss of sales. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role are to: + Prepare process equipment (including but not limited to Bioreactors & ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest discards, Transfer lines (buffers, cTCF), Hoses and small parts; + Clean and Sterilize equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In-Place) procedures; + Perform daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry, Kogenate, and Jivi); + Operate equipment for these processes including: + Inoculate and monitor bioreactors; + Process cTCF material to Continuous Cell Separation (CCS); + Operate Chromatography, MAEF, MAVF and TFF skids; + Process MAEF material using closed thaw process, step elution chromatography, Membrane Absorber and filter clearance technology, and gradient controlled SP column separation techniques; + Operate 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products; + Perform PEGylation of JIVI in process material using TFF technology; + Operate automated bagging systems; + Blast Freeze product for storage; + Dispense chemicals and formulate solutions; + Prepare acids and bases as necessary; + Perform aseptic operations; + Take, analyze and submit samples as required throughout the process; + Monitor and control operation with computer control systems; + Complete all routine check sheets; + Clean equipment and maintain clean and orderly production facilities; + Perform in-depth troubleshooting and root cause analysis of Kovaltry and Jivi equipment and process failures; + Contribute to continuous improvement opportunities; + Perform all operations in compliance with cGMP; + Perform other related duties as assigned. **WHO YOU ARE** Your success will be driven by your demonstration of our life values, more specifically related to this position, Bayer seeks an incumbent who possesses the following: **REQUIRED QUALIFICATIONS** + Requires completion of two-years' college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy; + Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above: + Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes; + Continuous Cells Separation equipment preparation and process/controls; + Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature controls); + Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography; + Membrane Absorber technology, viral removal techniques and tangential flow filtration technology. Large scale chromatography, TFF technology; + Familiarity with cGMP's and applicable agency regulations; + Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP's, BPR's, etc.; + Good verbal and written communication skills; + Work weekends, holidays and overtime as required; + Acceptable attendance and performance; + Able to work both independently/self-directed with minimal supervision and in a team environment; + Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules; + Computer skills required. Including: ability to learn software applications such as the learning management system (LMS), document control, e-mail (Outlook), Sentry DR/CAPA System, etc.; + Must be able to cope with fast paced operations and repeatedly perform multi-step simultaneous operations with high degree of accuracy; + Must be able to work under BC III (Class 100,000) gowning conditions; + Must be able to lift up to ≤50 lbs. and push/pull up to 400 lbs. with assistance; + Must be able to withstand frequent repetitive movement, stooping, crouching, kneeling, climbing (ladders), and sitting; + Must be able to work in cold rooms; + Must not have unusual sensitivity to typical lab chemicals or gloves (i.e. sanitizing agents), use required chemicals and wear protective clothing (PPE) and gowning as required; + Must be able to differentiate color in order to monitor DCS computer and identify items using color-coded labels; + Must meet Occupational Demands/Physical Requirement checklist; + Blood test for Hepatitis B and vaccine required. Employees can expect to be paid­­­­­­­­­­­­­­­­­ an hourly wage of $39.76 per hour. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This wage 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 open for applications until at least 6-5-25 **YOUR APPLICATION** 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 Science for a better life, 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. Bayer is an E-Verify Employer. **Location:** United States : California : Berkeley **Division:** Pharmaceuticals **Reference Code:** 846667 **Contact Us** **Email:** hrop_usa@bayer.com **Job Segment:** Biology, Biotech, Cell Biology, Medical Lab, Operations Manager, Science, Healthcare, Operations

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Hourly pay, Weekend work,

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