Senior Scientist, Process Robustness & Investigations (CPV/APQR)

Job Description

Job Description

Job Description

• 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.

• 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 BMS standards and participating in best practice forums consistent with function responsibilities

• Identify key Opex opportunities, using data driven evaluations

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 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

• 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

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 of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

\nCompany Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities