Bristol-Myers Squibb Company

RSCR Scientist

Location
New Brunswick, NJ, US
Posted
Dec 04, 2018
Ref
R1511976
Required Education
Bachelors Degree
Position Type
Full time
Highly motivated and productive scientist with expertise in either analytical support of manufacturing and/or development of biotechnology products or analytical support of manufacturing and/or development of pharmaceuticals in general. An experienced scientist with a strong background and well-developed perspective on GMP environments and the workflow and documentation associated with the approval and use of pharmaceutical product. Will review scientific reports, compile data and support operations for both development and commercial reference standard/critical reagent programs. Contribute to continuous improvement, harmonization and alignment across the RSCR organization. Experience working with pharmaceutical reference standard programs is desirable but not required.

The position will require the ability to work well in team situations, and have the flexibility to succeed in a dynamic and changing environment. Working knowledge and/or experience in modern analytical techniques is required. Previous direct experience/familiarity with electronic laboratory notebooks and electronic documentation systems would be a plus. The position requires sustained, intense communication with various departments within and outside of BMS so the candidate must have a firm command of the English language, as well as, excellent verbal, written and interpersonal communication skills. A solid background in computers and/or data acquisition systems is highly desirable. In all cases, the candidate will be responsible for managing documentation of analytical and operational data in compliance with cGLP/GMP's and departmental SOP's and will actively participate in interdepartmental project teams as required.

POSITION SUMMARY:

Highly motivated and productive scientist with expertise in either analytical support of manufacturing and/or development of biotechnology products or analytical support of manufacturing and/or development of pharmaceuticals in general. An experienced scientist with a strong background and well-developed perspective on GMP environments and the workflow and documentation associated with the approval and use of pharmaceutical product. Will review scientific reports, compile data and support operations for both development and commercial reference standard/critical reagent programs. Contribute to continuous improvement, harmonization and alignment across the RSCR organization. Experience working with pharmaceutical reference standard programs is desirable but not required.

The position will require the ability to work well in team situations, and have the flexibility to succeed in a dynamic and changing environment. Working knowledge and/or experience in modern analytical techniques is required. Previous direct experience/familiarity with electronic laboratory notebooks and electronic documentation systems would be a plus. The position requires sustained, intense communication with various departments within and outside of BMS so the candidate must have a firm command of the English language, as well as, excellent verbal, written and interpersonal communication skills. A solid background in computers and/or data acquisition systems is highly desirable. In all cases, the candidate will be responsible for managing documentation of analytical and operational data in compliance with cGLP/GMP's and departmental SOP's and will actively participate in interdepartmental project teams as required.

Duties/Responsibilities:

Support qualification of critical reagents and reference standards including report and Certificate of Analysis authoring, Author/review qualification protocols (as needed), support testing order management (forms, submissions) and data review. Act as AST-QC group RSCR liaison at regular resource/project meetings to provide updates, discuss testing commitments, timelines, updates, etc. Update monthly dashboard, managing scheduling and annual book of work. Monitoring inventory of critical reagents and reference standards using burn rate analysis/stock out calculations Provide backup assistance for Sample Management including inventory management updates, and troubleshooting Managing current work scheduling tool and qualification database

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

Proficient in the use of SharePoint and site management and customization Experienced in operating within a GMP environment and in strict adherence to SOPs Effective communication (verbal and written skills) Proficient in the maintenance, support and optimization of established operational processes and workflows Proficient in the use of analytical instrumentation (Waters UPLC, HPLC) Proficient in the operation of computer and data acquisition programs (Waters Empower AUC Software) Ability to operate in a complex, matrix environment Ability to apply effective time management, planning and coordination around multiple deliverables Positive attitude and ability to work well with others Ability to multitask

Education/Experience/ Licenses/Certifications:

Position requires a BS with 5 or more years of experience in a pharmaceutical research and development environment or in providing quality/coordination support for clinical or commercial production of pharmaceuticals, MS with 3 or more years of similar relevant experience.

Physical Demands:

This is primarily an operational support/laboratory role for a development/commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting, including, working independently or within a team, working in laboratory settings, and handling chemicals.

Work Environment:

This position requires both laboratory and office work.

Travel:

This position may require travel based on business need, domestic and internationally.

Supervisory Responsibilities:

N/A