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Title: Assistant Scientist, Clinical QC Microbiology

Location: Warren, NJ

The Assistant Scientist, Development QC role is responsible as single point of contact for all deviations, OOS, CAPA and training management. Additional responsibilities include, assisting in technical transfer activities from research to clinical QC and managing the general operation, workflow of the QC function. The candidate’s responsibilities include, but are not limit to, creating technical protocols, reports, SOPs, risk assessments, and specifications.

Qualifications & Experience:

Bachelor’s Degree required, preferably in Science.Advanced Degree preferred.5-8 years of relevant work experience, preferably in a regulated environment.An equivalent combination of education and experience may substitute.Advanced experience and knowledge of Compendial methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)Minimum of 5 years of QC experience or related GMP laboratory experience in the pharmaceutical industry.Advanced ability to accurately and completely understand, follow, interpret, apply Global.Advanced knowledge if investigation writing, CAPA and deviation management.Knowledge of Sample Management and QC operations in a cGMP regulated environment.Advanced knowledge of risk management and the proven ability to apply the concepts of risk management effectively.Familiar 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 technical writing skills.Advanced problem-solving ability/mentality, technically adept and logical.Ability to represent the interests of the group on cross-functional teams.Ability to work with management locally and globally.Advanced ability to communicate effectively with peers, department management and cross- functional peers.

Key Responsibilities:

Responsible for managing Development Operations QC Quality System records in compliance with company guidelines.Ensures control of systems, processes and product through supporting the maintenance of a Quality System.Ensures QC procedures and processes are maintained, adequate and efficient.Leads and coordinates QC team member reviews of protocols and procedures.Ensures deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents.Designs and/or implements and sustains Lean lab initiatives such as 5S, deviation reduction, right first time, permanent inspection readiness, visual management.Provides oversight to risk management activities using FMEA.Author SOPs, assay qualification, protocol, report and transfer and gap analysis reports.Identify opportunities to improve technical and operational systems, practices, and technologies.Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents.Responsible for assisting in Development Operations QC sample management programs.Collaborates with the QC Sample Management team and ensures GMP compliance of the laboratory area and operations under her/his responsibility.Ensures the chain of custody of QC samples is maintained throughout the complete life span of samples including raw materials, bulk drug substances, packaging materials and stability samplesDrive and Manage projects within the group.Using technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department.Participate on tech transfer QC teams for assay qualification of molecular and cell- based assays for cell therapy programs. Design and generate assay qualification protocols and reports.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.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.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.

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.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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