What are the responsibilities and job description for the Senior Associate Scientist position at Axelon Services Corporation?
Pay Range :$50 - $53/hr
Job Description: 50% onsite required
Senior Scientist
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.
The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
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
Job Description: 50% onsite required
Senior Scientist
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.
The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.
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
Salary : $50 - $53
