Senior Scientist

Job Description:

• 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.
• Support the monitoring/trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply.
• Trend CPV parameters, including but not limited to Manufacturing process parameters and Quality Control Release attributes for the MSAT organization, to support the Summit, NJ Cell Therapy facility.
• The purpose of a CPV program is to provide evidence that a process is running under a state of control.
• Monitor/trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines.
• The CPV program includes supporting the APQR, as required by regulatory agencies.
• Support the CPV and APQR reports and approvals.
• Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ.
• This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
• 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 standards and participating in best practice forums consistent with function responsibilities
• Identify key Opex opportunities, using data driven evaluations
• Required to adhere to the current policies and procedures.
• Required to gown to access classified manufacturing areas when needed.

Qualifications:

• Bachelor's Degree required (science or engineering is preferred)
• Graduate or higher-level Degree is preferred
• 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.
• 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
• Summary Report creation/Review in support of CPV (Continuous Process Verification) and APQR (Annual Product Quality Review).

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.