# Prod Spec III Cell Culture Tech Center - Berkeley, CA

**Company**: Pharmaceuticals
**Location**: Berkeley, California
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $97,000.00 to $125,000.00
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://talent.bayer.com/careers/job/562949978629199?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ab5a223d-c62

## Description

At Bayer, we're visionaries driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is a reality.

As a Production Specialist III – Cell Culture Technology Center (CCTC), you'll be responsible for manufacturing monoclonal antibody (mAb) drug substance within the CCTC and Manufacturing Biologics cluster.

**Your Tasks and Responsibilities:**

- Execute end-to-end manufacturing operations for mAb drug substance across Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, acting as a subject matter expert (SME) for at least one area.

- Manufacture products across multiple life-cycle phases, from clinical through launch, managing differences in documentation, sample handling, automation, and cGMP expectations.

- Handle and troubleshoot single-use technology (SUT) throughout the manufacturing process, ensuring reliable and compliant operation of equipment and systems.

- Monitor and control processes using data trending and statistical process control, working cross-functionally to maintain a controlled state and escalate and investigate issues as needed.

- Author, redline, and review controlled documents for equipment and processes, ensuring alignment with CCTC platform philosophy.

- Create, own, and drive business processes of moderate complexity within CCTC to ensure operational readiness and efficient manufacturing.

- Participate in regulatory and internal audits, including leading internal audit walkthroughs, and support commissioning, qualification (IOPQ), and execution of C&Q documentation for CCTC equipment.

- Support development of training curricula and materials, deliver training as an SME, and ensure your own training remains compliant and up to date.

- Identify and drive continuous improvement opportunities, challenge the status quo, and promote safe behaviors.

- Act as a delegate to the Sr. Production Specialist and CCTC Production Manager to support business continuity and leadership coverage.

**Who You Are:**

- Bachelor's degree with 4+ years of industry experience, or a Master's or PhD with no prior industry experience, preferably in a science-related discipline.

- Demonstrated ability to work with flexibility, adapt to last-minute production schedule changes, and provide off-hour coverage.

- Strong independent thinking and decision-making skills, with the ability to make logical decisions for multiple process workstreams.

- Proven ability to understand and troubleshoot equipment, resolve issues independently, and experience with single-use technologies.

- Experience with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing.

- Proficiency with business IT systems and Microsoft Office.

**Benefits:**

- Salary between $97,000.00 to $125,000.00

- Additional compensation may include a bonus or commission

- Health care, vision, dental, retirement, PTO, sick leave, etc.

## Skills

### Required
- monoclonal antibody manufacturing
- cell culture technology
- single-use technology
- data integrity
- regulatory compliance
- cGMP
- Microsoft Office

### Nice to have
- Lean manufacturing principles
- continuous improvement methodologies
- technology transfers
- new product introductions

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Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949978629199?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)