National Guard Employment Network
Manager, QA Engineering (Analytical Lead) - Warren, NJ
National Guard Employment Network, Warren, New Jersey, us, 07059
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
This role is responsible for providing quality oversight of quality control bioanalytical and microbiological safety testing for release of clinical and developmental products in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Key Responsibilities:
QA lead on quality control bioanalytical and microbiological related activities:
Review and approve phase appropriate validation protocols/reports, stability protocols/reports, other GMP-related documentation and resolve discrepancies as needed.Review and approve drug product and raw material specifications.Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.Interact and collaborate with cross-functional teams to achieve common goals.Must be knowledgeable on change control process.Must be knowledgeable on the process and associated methods for the assigned product.Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.Complete quality oversight of documentation and processes to assure compliance with company procedures, FDA, EU, and other regulations outside of the US.Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.Ensure SOPs (Standard Operating Procedures) are adequate to review and confirm appropriateness of data.Display Leadership Qualities
Create an environment of teamwork, open communication, and a sense of urgencyPromote a mindset of continuous improvement, problem solving, and preventionDrive strong collaboration within the site and across the networkBuild trust and effective relationships with peers and stakeholdersDrive improvements to remove inefficiencies, improve quality and optimize productivity.Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
Additional Qualifications/Responsibilities
Qualifications & Experience:
B.S. degree required.Minimum of six years of experience in the pharmaceutical or related industry.Equivalent combination of education and experience acceptable.Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.Must have knowledge of technology transfer for manufacturing processes. Knowledge of cell therapy manufacturing, flow cytometry and/or PCR is preferred.Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.Work is self-directed.Must effectively communicate and interact with management and stakeholders with clarity and accuracy.Understands fundamental scientific problems.Must have strong quality background.Working Conditions:
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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.
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
This role is responsible for providing quality oversight of quality control bioanalytical and microbiological safety testing for release of clinical and developmental products in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Key Responsibilities:
QA lead on quality control bioanalytical and microbiological related activities:
Review and approve phase appropriate validation protocols/reports, stability protocols/reports, other GMP-related documentation and resolve discrepancies as needed.Review and approve drug product and raw material specifications.Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.Interact and collaborate with cross-functional teams to achieve common goals.Must be knowledgeable on change control process.Must be knowledgeable on the process and associated methods for the assigned product.Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.Complete quality oversight of documentation and processes to assure compliance with company procedures, FDA, EU, and other regulations outside of the US.Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.Ensure SOPs (Standard Operating Procedures) are adequate to review and confirm appropriateness of data.Display Leadership Qualities
Create an environment of teamwork, open communication, and a sense of urgencyPromote a mindset of continuous improvement, problem solving, and preventionDrive strong collaboration within the site and across the networkBuild trust and effective relationships with peers and stakeholdersDrive improvements to remove inefficiencies, improve quality and optimize productivity.Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
Additional Qualifications/Responsibilities
Qualifications & Experience:
B.S. degree required.Minimum of six years of experience in the pharmaceutical or related industry.Equivalent combination of education and experience acceptable.Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.Must have knowledge of technology transfer for manufacturing processes. Knowledge of cell therapy manufacturing, flow cytometry and/or PCR is preferred.Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.Work is self-directed.Must effectively communicate and interact with management and stakeholders with clarity and accuracy.Understands fundamental scientific problems.Must have strong quality background.Working Conditions:
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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.