Senior Specialist Quality Assurance Engineering Cell Therapy

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist is responsible for providing quality oversight for Site Technology Transfer activities in accordance withBMS policies, standards, procedures and Global cGMP in a fastpaced, highly collaborative clinical manufacturing facility producing cell therapy CAR T and engineered T Cell products for first-in-human and early phase trials.

REQUIRED COMPETENCIES :

Knowledge, Skills, and Abilities

Must have GMP, Quality, and in-depth risk management knowledge.


Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.
Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
Effectively communicates internally within the function and with internal and external crossfunctional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Consults management for advice on complex issues.
Work is self-directed.
Is recognized Subject Matter Expert within the group.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
Understands fundamental scientific problems.
Able to write and review reports with clarity and brevity.
Able to produce data reports with precision. DUTIES AND RESPONSIBILITIES :
Supports all activities for the QA Engineering group.
Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
Review media simulation activities to ensure successful execution and documentation.
Ensure site is compliant with global and regulatory data governance and data integrity requirements.
Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.
Review/approval of technology transfer related deviations/discrepancies.
Ensure the site stability program meets global and regulatory requirements.
Ensure process and method transfers, method qualification/verification, and analyst trainings meet company and regulatory requirements. EDUCATION AND EXPERIENCE (As Applicable):
Bachelor's degree Required.
Minimum of 7 years of Quality Assurance and/or Quality Control-related GMP experience in the pharmaceutical industry.Strong Knowledge of Method Validation, Method Qualification or Technology/Process Transfer RequiredStrong Knowledge of GMP GuidelinesWorking knowledge of qPCR, Elisa or Flow Cytometry Testing Techniques Preferred.
Equivalent combination of education and experience acceptable.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 with the resources to pursue their goals, both at work and in their personal lives. Company: Bristol-Myers Squibb Req Number: R1526978_EN Updated: 2020-07-01 00:00:00.000 UTC Location: Warren,New Jersey


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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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