Biostatistician

Senior Scientist of Biostatistics

Location: Summit West, NJ

Work Schedule: Mon -- Fri, Business Hours

Client Hybrid role

Hybrid = 2 days onsite 1 week, 3 days onsite the next week, subject to change based on the needs of the business.

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.

Position Summary:

The incumbent will 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.

The Incumbent will 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. The incumbent will 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. The incumbent will support the CPV and APQR reports and approvals.

This position is based in Summit, 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) 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 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.

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