Create and maintain business tools and standard operating procedures for Vector SPC and CPV programs creating standard work for all manufacturing sites and seamless integration of cross site data trending to enable root cause analysis, CAPA identification, and process monitoring documentation.
Serve as the interface for CMO sites, product teams and laboratories ensuring consistent data monitoring activities.
In partnership with product and site teams execute "end to end" product robustness reviews by analyzing, vector process and analytical data.
Promote innovative and efficient approaches to SPC and CPV based on risk-based elements and considerations unique to cell therapy production.
Manage complex cross-functional projects/programs using project management techniques and tools that is appropriate for the given project.
Partner with IT, MS&T, and AS&T to create and maintain required data structures or hierarchies to include new molecule/modality in new or existing sites.
Train end users on process robustness systems and procedures.
Requirements
Bachelor’s degree or equivalent in relevant discipline with a minimum of 8-10 years of relevant experience.
Masters preferred (but not required).
Time spent in advanced degree programs may be considered as equivalent relevant experience.
Expertise in statistical data analysis and experience with statistical programs such as Discoverant, JMP, etc.
Ability to program using data science programming languages such as Python, R, etc., is a plus.
Expert understanding of cGMP regulations and/or business and documentation processes.
Highly proficient in technical writing and technical presentations, contributing to broader external and internal scientific community as appropriate.
Ability to work in a self-driven, performance/results oriented, fast paced matrix environment.
Strong interpersonal skills required to work with teams in different functions and organizations.
Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
Detail oriented with excellent verbal and written communication skills.
Benefits
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical data analysisprogrammingPythonRtechnical writingtechnical presentationsdata scienceprocess monitoringroot cause analysisCAPA identification
Soft skills
interpersonal skillsself-drivenperformance orientedresults orienteddetail orientedcommunication skillsability to meet deadlinesprioritizationcross-functional teamworktraining