Production Specialist III Cell Culture Technology Center
Bayer is a global enterprise with core competencies in the Life
Science fields of health care and agriculture. Its products and
services are designed to benefit people and improve their quality
of life. At Bayer you have the opportunity to be part of a culture
where we value the passion of our employees to innovate and give
them the power to change.
Production Specialist III Cell Culture Technology Center YOUR
TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Production Specialist
III Cell Culture Technology Center , are to:
Responsible for all aspects of clinical manufacturing in the
following areas: Cell Expansion, Cell Culture, Purification,
Solution Preparation and Weigh/Dispense. Employee will work
seamlessly across all areas and will be a subject matter
expert (SME) for not less than (NLT) one area.
Participates in new products introductions (NPIs) into CCTC with
support from Biologics Development (BD) and Manufacturing Sciences
and Technology (MSAT). Ensures all activities are performed to
schedule. Acts as delegate to Sr. Production specialist.
Collaborates with BD and MSAT to ensure cross functional
alignment with platform process, equipment, raw materials and/or
automation for not less than (NLT) one area.
Manufactures products in various phases of product life cycles
from clinical thru launch. Clearly understands, communicates,
and manages differences in terms of documentation, sample handling,
automation and Curent Good Manufacturing Practice (cGMP)
for different phases of product life cycle.
Handles and troubleshoots Single Use Technology (SUT) from end
to end in manufacturing process.
Monitors and controls processes using data trending and / or
statistical process control. Works cross functionally to ensure
process is controlled and issues are escalated and
Authors, redlines and reviews controlled documents for various
equipment/processes. Ensures alignment with platform philosophy for
CCTC. Assesses documentation impact of proposed changes in
materials, equipment and provides decision making recommendations
Effectively employs all methods of communication (oral, written,
presentation) to ensure knowledge and information transfer across
shifts, to management, and cross functionally.
Creates, owns, and drives business processes of moderate
complexity in CCTC. Owns and drives to ensure operational readiness
and manufacturing of products efficiently.
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.
Participates in regulatory and internal audits. Leads internal
Performs commissioning and IOPQ of CCTC equipment and executes
Participates in safety investigations for CCTC and promotes safe
behaviors at all times. Partners cross functionally to identify and
implement corrective actions.
Supports development of training curricula and generates
training materials for CCTC team. Delivers training as SME. Ensures
own training is always in compliance.
Actively looks for opportunities to improve, proposes solutions,
and encouragessame of others. Drives continuous improvements.
Challenges the status quo and embraces change.
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:
Bachelor's Degree with 4+ Years of industry experience, or
Master's Degree or PhD with no prior industry experience
Demonstrates strong tendency towards independent thinking and
decision making. Able to make logical decisions independently for
multiple process work streams with limited information or
supervision available. Clearly articulates decision making
Works with highest level of flexibility. Responds easily to last
minute changes to production schedule. Must be able to change shift
schedule based on business and process needs. Must provide off-hour
(night and weekend) coverage to meet business requirements on short
Understands functionality of multiple types of equipment such
that can troubleshoot and resolve equipment and process related
Self-motivated. Drives own development, sets goals, teaches and
encourages others. Provides formal and informal feedback
Experienced with data integrity, regulatory, and cGMP
requirements for pharmaceutical manufacturing
Previous experience in technology transfers or New Product
Introduction is beneficial
Experienced with Lean manufacturing principles
Experienced with business IT systems
Experienced with Microsoft Office. Excellent computer skills
Acts as a change agent of equipment with moderate complexity and
processes. Applies effective change management
Ability to lift 45 lb.
Your application Bayer offers a wide variety of competitive
compensation and benefits programs. If you meet the requirements of
this unique opportunity, and you have the "Passion to Innovate" and
the "Power to Change", we encourage you to apply now. To all
recruitment agencies: Bayer does not accept unsolicited third party
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
Country: United States
Reference Code: 49559
Functional Area: Production&Manufacturing
Entry Level : Professional
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