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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.

Production Specialist II (CCTC)

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with sending units and other Manufacturing Science and Technology (MSAT) support functions for new product introductions and ensure platform alignment.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

• Responsible for working across all areas and unit operations but may dedicate efforts towards specific operations as needed. Employee will be a Subject Matter-Expert (SME) for specific unit operation(s) and/or focused areas.

• Responsible for all tasks related to New Product Introductions (NPIs) into CCTC that are relevant to their areas of focus. Ensures all activities are performed to schedule. Acts as delegate to Production Specialist II.

• Collaborates with the given sending unit and Manufacturing Science and Technology (MSAT) support functions to ensure cross functional alignment with platform process, equipment, raw materials and/or automation for specific unit operation(s) and/or areas of focus.

• Manufacture products in various phases of product life cycles from clinical through launch.

• Manages differences between multiple products. Ensures manufacturing is executed correctly regardless of product and/or life cycle phase.

• Operates the process using Single-Use Technology (SUT) from end to end. Troubleshoots all respective SUT for their areas of focus.

• Retrieve, record, and analyze sample results to control processes.

• Monitors process using data trending for their areas of focus. Works cross functionally to ensure the process is in control. Follows through to ensure all concerns are fully resolved.

• Redlines controlled documents for CCTC and incorporates stake-holders feedback.

• Reviews documents for their areas of focus and provides feedback to ensure alignment with platform philosophy for CCTC.

• Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.

• Creates business processes in CCTC for their areas of focus to ensure manufacturing of products efficiently. Challenge status quo and provides continuous feedback for improvements.

• Supports investigation of deviations. Partners cross functionally to determine product impact and root cause. Executes manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence.

• Participates in regulatory and/or internal audits/walkthroughs. Acts as SME for their areas of focus.

• Performs commissioning the Installation Operational Performance Qualification (IOPQ) standards of equipment and executes Commissioning and Qualification (C&Q) documentation in their areas of focus.

• Participates in safety investigations for CCTC and promotes safe behaviors at all times. Partners cross functionally to identify and implement corrective actions.

• Supports generation of training materials and delivers training as SME for their areas of focus. Ensures own training is always in compliance.

• Actively looks for opportunities to improve, proposes solutions, and encourages the same of others. Drives continuous improvements to their areas of focus. Challenges the status quo and embraces change.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications :

• Bachelors of science or related field with 2+ years of industry experience.

• Demonstrates strong tendency towards independent thinking and decision making.

• Ability to think critically and make logical decisions independently for respective area of focus using educational training, professional experience, and established procedures.

• Acts as a change agent of equipment and processes with respective areas of focus. Applies effective change management behaviors

• Must work with the highest level of flexibility to adjust schedules during Active and Non-Active Manufacturing Phases. Must be able to provide off-hour (night and weekend) coverage to meet business requirements on short notice, as required during Active Manufacturing Phases. During Non-Active Manufacturing Phases, the team will operate on a traditional schedule, Monday – Friday 8am to 5pm.

• Understands equipment functionality and troubleshoots to resolve equipment/process related issues independently within their areas of focus.

• Self-motivated individual who drives their own development, sets goals, teaches and encourages others. Provides formal and informal feedback.

• Understands and applies data integrity, regulatory and cGMP requirements for pharmaceutical manufacturing.

• Understands and implements Lean manufacturing principles.

• Experienced with business IT systems

• Excellent computer literacy skills with experience with Microsoft Office Suite.

• Ability to lift 45 lb.

Preferred Qualifications :

• Previous experience in technology transfers or New Product Introduction is beneficial.

This role operates in a dynamic capacity. During periods of non-active manufacturing phases this team operates on a standard schedule Monday – Friday, 8am to 5pm. During periods of active manufacturing production this team adapts to operate on rotating shift schedules for 24/7 coverage based on the following structure below:

Shift Days :

• Sunday – Thursday

• Tuesday – Saturday

Shift Hours :

• Dayshift: 6am – 3pm

• Swingshift: 1pm – 10pm

• Nightshift: 9:30am – 6:30am

Employees can expect to be paid a salary of approximately between $65,599 to $98,398.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary (or 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 March 6th.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 839548

Contact Us

Email: hrop_usa@bayer.com

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