Manager - Senior Manager Quality Control Bioanalytical

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose and Scope of Position

The Manager/Senior Manager, Quality Control Bioanalytical, is responsible to work both independently and with the team to manage the general operation and workflow of the bioanalytical function and perform routine and non-routine testing. The candidate’s responsibilities include, but are not limit to, creating technical protocols, reports, SOPs, risk assessments, and specifications. The successful candidate will have the opportunity to provide innovation, disciplined scientific methods, critical thinking, and collaboration, to develop and implement new cell therapy methods for Development QC.

Required Competencies: Knowledge, Skills, and Abilities

Advanced hands-on experience with various analytical techniques including but not limited to: ELISA, qPCR, Flow Cytometry and scientific knowledge in the cell therapy product release field.

Able to perform responsibilities independently with minimal management oversight.

Advanced ability to accurately and completely understand, follow, interpret, apply Global

Regulatory and cGMP requirements.

Advanced technical writing skills.

Advanced ability to accurately and completely understand, follow, interpret and apply Global

Regulatory and cGMP requirements

Advanced problem-solving ability/mentality, technically adept and logical.

Ability to represent the interests of the group on cross-functional teams.

Ability to set priorities of the group and manage timelines.

Ability to work with management locally and globally.

Advanced ability to communicate effectively with peers, department management and cross- functional peers.

Duties and Responsibilities

Responsible for maintaining the laboratory test schedule, allocation of resources and delivery of results within established clinical batch release timelines.

Using technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department.

Review routine test results such as, but not limited to, qPCR, Elisa, and Flow Cytometry for In process and Finished drug products.

Represent QC in cell therapy CMC teams and sub-teams as a Technical Project Lead, to coordinate multi-functional analytical activities for early-phase clinical programs.

Lead investigations for OOS/Deviation/CAPA if required.

Author SOPs, assay qualification, protocol, report and transfer and gap analysis reports.

Identify opportunities to improve technical and operational systems, practices, and technologies.

Drive and Manage projects within the group

· Accepts responsibility for group projects; designs and executes experiments, analyzes

results, and writes technical summary reports.

· Capable of handling complex issues and solving problems with minimal guidance.

· Prepare and present continuous improvement projects to management.

· Utilize advanced scientific principles to assist in analytical testing methods and the proper

use of laboratory equipment.

· Comprehensive understanding of guidelines and can independently develop, write

and execute method, protocols, reports, and other related documents.

· Assist senior management with investigations and deviations.

Carry out management authority for review and approval activities

Serve as author or technical reviewer of appropriate departmental procedures.

Review documentation as required by laboratory procedures.

Perform approvals for relevant laboratory activities.

Provide Guidance and Leadership

Support the development and career progression of laboratory personnel

Perform on-the-job training (OJT) for laboratory employees.

Assist senior management with the development, implementation, and deployment of training.

Coach analyst on troubleshooting analytical methods and scientific equipment.

Teach junior scientists on theory and application of analytical methods.

Lead and develops best practices.

Education and Experience

Bachelor’s Degree required, preferably in Science.

Advanced Degree preferred.

10-15 years of relevant work experience, preferably in a regulated environment.

An equivalent combination of education and experience may substitute.

Working Conditions

The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.

The incumbent must analyze numerical values on a daily basis.

The incumbent will be working a laboratory setting up to six (6) hours per day.

The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com