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Syracuse, New York - USD Full Time Posted: Wednesday, 15 January 2020
 
 
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.

The Quality Control Data Assessment Lead working within a quality control environment with bio/pharmaceutical analytical and statistical experience will provide direct data assessment support and lead statistical analysis of method performance as part of the Syracuse Method Performance & Data Trending Team (MPDT). This group partners with BMS biologics Quality Control (QC), Analytical Science and Technology (AST), Process Monitoring Analytics (PMA), Manufacturing Technology (MT), Third Party Manufacturing (TPM), Global Manufacturing & Supply-IT (GMS-IT).

Duties/Responsibilities:
  • Provide routine monitoring and performance analysis of quality control analytical methods using applicable statistical tools.
  • Provide statistical guidance to MPDT team, inclusive of authoring investigational reports, to support findings in QC analytical data related to release data (OOS) and method performance (OOT) generated within Syracuse QC laboratories.
  • Facilitate discussions with QC method subject matter expert (SME) to ensure robust data analysis is completed to support method performance investigations.
  • Provide method performance reports, data and/or statistical support to cross-functional teams (Syracuse QC/QA, AST, MST, TPM, GMS-IT) to drive method performance improvements and/or changes.
  • Provide direct support to QC laboratories to drive method performance improvements.
  • Support QC analytical data request activities including compilation and data verification.
    Collaborate with BMS network analytical QC teams and Analytical Sciences & Technology in the globalization, improvement and standardization of method performance monitoring processes, procedures and systems.
  • Provide direct support in the optimization and standardization of analytical method performance data assessments, monitoring and trending capabilities using SAS, JMP, Discoverant, Analytical Data Mining Tool (ADMT), etc.
    Partner with GMS-IT during build and implementation of Process Management Informatics (PMI) and Lab Execution System (LES) application hierarchy/procedure implementation for all methods performed within the Syracuse Quality Laboratory to ensure method performance monitoring consistency.

    Provide support during PMI/LES application maintenance related activities (Pathfinder, Discoverant, LES, etc.).

QUALIFICATIONS:

Specific Knowledge, Skills, Abilities, etc:

The ideal candidate should demonstrate the following proficiencies:
  • Broad experience in trending/statistical analysis of biological quality control method data.
  • Competent with statistical software (SAS/JMP, Discoverant, Spotfire)
    Working knowledge with data management systems; LIMS, Process Management Informatics (PMI), and LES applications such as SampleManager LIMS, PRIMR/Discoverant, and Accelrys LES.
  • Strong oral and written communication skills.
  • Strong interpersonal skills: this position requires collaboration with cross-functional teams within BMS network.
  • Demonstrates ability to work independently with limited supervision
  • Demonstrates organizational, well developed attention to detail, and time management skills.
  • Thorough understanding of cGMP compliance and laboratory documentation procedures (eg, good documentation practices, SOP's, etc.).

Education/Experience/Licenses/Certifications:

The ideal candidate will have a BS or MS in Statistics or related discipline with minimum of years of bio/pharmaceutical related in relevant fields or M.S. degree with minimum of 3 years of experience. Additionally, the ideal candidate will have a BS degree in Biological Sciences, Chemistry, or related field.

Physical Demands:

This is an office-based position that routinely requires sitting extended periods of time to carry out a variety of both manual and computerized data entry and processing activities. Repetitive arm, hand and finger movements are constant in regards to data entry/processing, and report writing tasks. There will be occasional to frequent use of hand-held devices such as writing utensils, calculators, etc. Occasional standing and walking about the office is required. Lifting, bending, twisting, squatting, crouching, kneeling, reaching, or climbing is not a significant component of the job.

Work Environment:

This position primarily involves working at an office desk, usually using a computer workstation. Employee will be part of a team, but will often work independently. Working during a weekend and occasionally holidays may be expected. This position is based indoors in adequately heated and ventilated work space.

Travel:
  • This position requires up to 5% of travel

Supervisory Responsibilities: N/A

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.

Syracuse, New York, United States of America
IT
USD
Bristol-Myers Squibb Company
Bristol-Myers Squibb Company
JSC7050A67330E1D8C62B079FEEE01AC48856704C14DE327511F/828270210
1/15/2020 6:03:20 AM

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