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M

Global Product Development and Supply - Sr. Scientist Engineer Investigator

Mindlance
  • 🇺🇸 United States
  • On-site
  • Senior
  • 14 hours ago
  • JMP
  • Python
  • GMP
  • SPC
  • Minitab
  • SAS
  • Lean Manufacturing
14 hours ago
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Global Product Development and Supply - Sr. Scientist Engineer Investigator
Job Title: Sr. Scientist Engineer Investigator
Location: Madison, NJ – 07940 | Hybrid - 50% onsite
Duration: 06 Months (Possibility of extension)

(W2 Assignment)
Must Have List:
  • Strong working knowledge of data preparation tools in R.
  • Strong working knowledge of general statistical analysis tools in JMP, R, or Python and specifically tools for process monitoring and capability analyses.
  • Ability to successfully engage and support stakeholders as part of a matrix team.
  • 5+ years pharmaceutical experience in a GMP-regulated setting.
  • 3+ years in a data management and analytics role.

Position Summary:
  • Senior Scientist, Process Robustness & Investigations (CPV/APQR)
  • Work Location: 50% onsite at Giralda Farms, Madison, NJ
  • Hours: Mon-Fri 9am-5pm
  • The Senior Scientist is a member of the Global Manufacturing Science and Technology Process Robustness and Investigations team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting.
  • The incumbent will support the monitoring/trending of production and release testing parameters, in support of the cell therapy network’s mission to provide personalized cell therapy products for both global commercial supply. The Incumbent will contribute to our mission of driving manufacturing success by assess data completeness, merging data, trending CPV parameters, and configuring analytic/monitoring systems/platforms for the process monitoring network.
  • The purpose of a CPV program is to provide evidence that a process is running under a state of control. The CPV program includes supporting the APQR, as required by regulatory agencies. The incumbent will monitor/trend , alerting stakeholders of any gaps or drifts while supporting or directly authoring reports to support established timelines.
  • Work scope will include commercial manufacturing for all cell therapy products and in-network cell therapy manufacturing sites. This role will work with site and global stakeholders, including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
  • This position is based in Madison, NJ. Global travel up to 10% of time may be required.

Duties/Responsibilities:
  • Provides support to maintain the site Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
  • Provide multivariate analysis (MVA) or other statistic 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
  • Supporting any proactive initiatives or investigations related to drift in product performance
  • Author and support review/approval of global and site documents within the scope of CPV and APQR
  • 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 Client standards and participating in best practice forums consistent with function responsibilities
  • Identify key Opex opportunities, using data driven evaluations

Working conditions:
  • The incumbent will be required to adhere to the current Client policies and procedures.
  • The incumbent will be required to gown to access classified manufacturing areas when needed.
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
  • Reports to Associate Director, Global Manufacturing Science & Technology (MSAT), Cell Therapy.

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 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
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

Global Product Development and Supply - Sr. Scientist Engineer Investigator · Mindlance

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