Associate Principal Scientist, Custom Cell Culture Media

Job description

3168230
Additional Cities

Logan
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Life Sciences
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Utah
Postal Code

84321
Role Summary/Purpose

Custom Media Qualifications Subject Matter Expert, will work cross functionally with Sales, Field Application Specialists, Manufacturing Sciences, Customers and Manufacturing to define the requirements for customer qualifications and new custom product opportunities, and coordinate between the customer and the rest of the team during the qualification process. Customer Qualifications SME will also provide internal guidance for alignment with customer and industry requirements.
Essential Responsibilities

Duties include (but are not limited to):
1. Liaison between sales, FAS, customer, MSAT and manufacturing for qualification studies or new custom product opportunities.
2. Create preliminary plan for qualification drawing from customer requirements, manufacturing capabilities, and regulatory requirements.
3. Write final customer facing reports for final release of qualification products.
4. Identify, develop and qualify current process improvements to ensure first time success with new custom products.
5. Mentor leaders and scientists specifically concerning use of systems such as Oracle, Master Control, Magic and others.
6. Mentor leaders and scientists on urgency, meeting deadlines, writing appropriate study designs which would include resource requirements and timelines.
7. Provide technical support and customer contact for complaint investigations. Be the contact with the customer to understand the complaint and provide input on resolving the complaint in a timely manner.
8. Be instrumental in writing customer facing reports for complaint/failure investigation. Provide technical approval for written customer reports.
9. Resolve urgent issues with standard and custom products
10. Maintain accurate records of projects and experiments
11. Provide safe processes that comply with all local and federal regulations

Quality Specific Goals:
1. Aware of and comply with the GEHC quality manual, quality management system, quality management policy, quality goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned quality & compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure compliance/closure of regulatory and quality requirements before approving design outputs/program deliverables
5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements

1. BS in Biology, Microbiology or a related field with minimum of 5 years’ experience in biopharmaceutical manufacturing and project management
2. Experience with Oracle, document management systems and other IT systems.
3. Experience with management or mentoring of scientific personnel.
4. Effective communicator, strong interpersonal and interdepartmental coordination skills
5. Self-motivated, organized and good problem solver
Desired Characteristics

1. MS / PhD in chemistry, biochemistry or a related field with minimum of 3 years experience in cell culture media development
2. Demonstrated record of innovation in process development
3. Experience with cell culture media manufacturing processes, single use process development, and drug development (small molecule or biologics)
4. Excellent oral and written communication skills
5. Self-starter who is results oriented, has good problem solving skills, and able to multi-task
6. Demonstrated ability to work in a collaborative, matrixed, and customer focused environment
7. Strong understanding of Quality by Design and Risk Management
About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen.
Primary Country

United States
Primary State/Province

Utah
Primary City

Logan