Product Specialist II Cell Therapy Drug Product

Bayer•Berkeley, CA

1d•Onsite

About The Position

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. The 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.

Requirements

Experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience.
Strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing.
Experienced with Lean manufacturing principles.
Experienced with business IT systems.
Excellent computer skills; experienced with Microsoft Office Suite of tools (Work, Excel, PowerPoint, Access, etc.)
Ability to lift 45 lbs.

Nice To Haves

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.
Computer programming or automation support

Responsibilities

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.
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.
Ensure all activities are performed to schedule.
Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.
Authors, redlines, and reviews-controlled documents for various equipment/processes.
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.
Raises and supports investigation of deviations.
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.
Participates in safety investigations for CT-MOD and always promotes safe behaviors.
Partners cross-functionally to identify and implement corrective actions.