What are the responsibilities and job description for the Biostatistician position at Montek System?
Job Details
Biostatistician
Summit, NJ
50% onsite
Duration: 12 months
The Senior Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.
Duties/Responsibilities:
- Provides support to maintain the site Statistical Process Control (SPC)
program, manufacturing performance trending and reporting.
- Provide multivariate analysis (MVA) modeling for improved process
understanding and robustness
- Continuously monitor CPV parameters, evaluate Statistical Alert Events
(SAEs), and take needed actions.
- Collaborate and support investigations by providing data and analysis
- Meet CPV and APQR timelines
- Establish and support predictive process monitoring analytics
- Supporting any proactive initiatives or investigations related to drift in
product performance
- Represent the site MSAT CPV team in cross-functional forums
- Performing review and approval of site documents within the scope of CPV
and APQR
- Ensuring safe and compliant cGMP operations and maintaining permanent
inspection readiness; actively supporting regulatory inspections
- Interacting with other teams including Operational Excellence, PMO (Project
Management Organization), site MSAT, Global MSAT, Quality Assurance,
Process Support/Engineering and Manufacturing Support, Manufacturing
Operations, Supply Chain Operations
- Staying current with industry trends and BMS standards and participating in
best practice forums consistent with function responsibilities
- Identify key Opex opportunities, using data driven evaluations
Qualifications Specific Knowledge, Skills, Abilities:
- Excellent knowledge of evaluating data using statistics and statistical tools, to
make data driven decisions.
- Proficiency in major statistical software packages and programming languages
(e.g., R, JMP, MINITAB, or SAS). JMP software preferred.
- Must be detail oriented and proven track record of impeccable time
management, to meet timelines.
- Possess strong verbal/written communication skills to enable working with
internal/external parties and/or collaborating with cross-functional teams.
- Expert knowledge of cGMP s and multi-national biopharmaceutical/cell
therapy regulations.
- Experience of facility/clean room design, process, equipment, automation,
and validation.
- Experience with the start-up, validation, and licensure of new
biopharmaceutical manufacturing facilities.
- Hands-on experience with single-use technologies, closed systems, and cold
chain/cryogenic technologies.
- Experience with Operational Excellence and Lean Manufacturing
Education, Experience, Licenses, Certificates:
- Bachelor s Degree required (science or engineering is preferred); Graduate
or higher-level Degree is preferred
- 8 or more years of work experience in the biopharmaceutical or related
industry
- 8 or more years of manufacturing support or related experience in the
biopharmaceutical industry
- Experience in CPV and/or APQR reporting preferred. May be substituted for
relevant experience in monitoring/trending performance of Quality
attributes
- Experience in cell therapy, biologics, or vaccine manufacturing/support
required
- Experience with Operational Excellence and Lean Manufacturing is a plus
