Cell Therapy Case Manager
Orca BioSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
QC Analytical Manager, Molecular, Cell Therapy in Devens, MA at Bristol-Myers Squibb
Devens, Massachusetts, United States
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Cell TherapyIndustries
Requirements
- Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment
- Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Excellent organizational and critical thinking skills
- Advanced problem-solving ability/mentality, technically adept and logical
- Advanced ability to communicate effectively with peers, department management, and cross functional peers
Responsibilities
- Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
- Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities
- Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Hire, mentor, and develop team members to support the business operations and employee career development
- Oversee training of the team members
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings
- Perform other tasks as assigned
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What shifts are available for the QC Analytical Manager role?
The available shift is Wednesday through Sunday, 6am to 2pm.
What is the salary range for this position?
This information is not specified in the job description.
What are the key responsibilities of this role?
The role involves supervising QC Analytical lab staff, overseeing daily lab activities for testing cell therapy drug product, performing data review, tracking metrics, driving improvements, managing change controls, and hiring/mentoring team members.
What is the company culture like at Bristol Myers Squibb?
The culture is described as challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and a focus on balance, flexibility, and reimagining cell therapy to transform patient lives.
What makes a strong candidate for this QC Analytical Manager position?
A strong candidate has experience managing QC lab operations in cell therapy or biopharma, skills in bioanalytical testing, data review, compliance, team leadership, hiring, mentoring, and driving continuous improvement.
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
Benefits
Flexible Work Hours
Hybrid Work Options
Professional Development Budget
Risks
Increased competition in oncology from emerging biotech firms like ArsenalBio.
BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.
Rapid AI and digital tech evolution may pose integration challenges for BMS.
Differentiation
BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.
The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.
BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.
Upsides
BMS's partnership with Medidata enhances clinical research processes and patient outcomes.
The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.
BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.
Related Jobs
RemoteRemoteInstrument Sales Representative - Molecular Spectroscopy
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years), Mid-level (3 to 4 years)
RemoteSenior Director, Quality Control Analytical Sciences
Abata TherapeuticsSalary not specified
- Full Time
- Expert & Leadership (9+ years)