Senior Cell Therapy Account Manager (Raleigh)
ArcellxSalary not specified
Senior Specialist, QC Compliance, Cell Therapy at Bristol-Myers Squibb
Summit, New Jersey, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Cell Therapy, Biotechnology, PharmaceuticalsIndustries
Requirements
- Bachelor’s degree in science, engineering, or related discipline (or equivalent combination of higher education and experience)
- 4+ years of experience in QC lab operations
- 2+ years of prior deviation/investigation experience
- 1 year of QC Microbiology lab experience
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- High problem-solving ability/mentality, critical thinking, technically adept and logical
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs
- Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work
- Knowledge of cell therapy analytical and microbiological testing
- Demonstrated experience with Quality management systems
- Demonstrated technical writing skills
- Demonstrated experience in laboratory or biomanufacturing
- Investigations and root cause analysis techniques
Responsibilities
- Lead and author QC deviation, laboratory investigations, CAPAs and change control
- Work with QC SMEs to conduct root cause analysis
- Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls
- Perform document revision, project, CAPA and deviation/investigation, change mgmt. actions, related tasks and/or continuous improvement efforts
- Train and mentor others on deviation, investigation, CAPA and change control process/procedures
- May support health agency inspection as equipment area subject matter expert
- Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums)
Skills
QC Deviation
Laboratory Investigations
CAPA
Change Control
Root Cause Analysis
Document Revision
GMP Compliance
Training
Mentoring
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
