Technical Lead, Downstream Manufacturing - Bristol Myers Squibb
Devens, MA
About the Job
Working with Us
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. Read more: careers.bms.com/working-with-us .
MAJOR DUTIES AND RESONSIBILITIES:
+ Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. - striving for right first time through adherence of GMP activities.
+ Change control identifiers - works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation.
+ Communicate and resolve operational variances.
+ Serve as the acting Shift Supervisor/Manager in absence of Shift Supervisor/Manager - Coordinate, direct and oversee work execution and manage personnel related issues.
+ Executes real time process monitoring - including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions.
+ Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
+ Participate in performance review discussion.
+ Leads routine investigations in Infinity as a low-level lead investigator - drives technical issues working with cross functional team members.
+ Support complex investigations and CAPAs - author, review, approval, in case of excess investigation beyond planned capacity.
+ Actively involved in safety related GEMBA, safety 4-box and safe IM investigation.
+ Actively involved in coaching of team members to prevent human related error and quality events.
+ Supports issue escalation with key stakeholders, troubleshooting systems and equipment issues, and working collectively to drive resolution.
+ Support real time process reports review and resolve open issues. Trend issues and strives to right first time.
+ Execute and drive continuous improvements such as procedure updates in electronic document repository (DCA)
+ Supports Tech transfer team through active participation in ensuring that new process can fit and executes in a sustainable manner.
+ Assigned area owner - drive facility upkeep through escalation of service requests, area walkthroughs, safety escalations (SAFE IM) and generation of safety communications.
+ Adheres to Good Manufacturing Practices and standard operating procedures.
+ Weighs and checks raw materials. Assembles, cleans, and sterilizes process equipment, monitors processes.
+ Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
+ Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.). Regularly provides training and operational guidance to staff.
+ Effectively uses process automation systems (i.e., Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e., SAP, Infinity, Maximo etc.).
+ Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
+ Support mentoring and coaching of operators on safety, executing task with a quality mindset, and prioritizing daily task to drive schedule adherence.
+ Assists with the coordination and implementation of special projects such as validation, complex investigations, and protocol execution.
+ May provide scheduling and work assignment guidance to peers. Modifies group work plan, schedule, or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary.
+ May attend departmental meetings as area representative (Schedule Review, Operations Huddle, Frozen, etc.).
+ Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action.
KNOWLEDGE AND SKILL:
+ B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
+ A minimum of 5+ year's process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
+ Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
+ Demonstrated experience in solving complex technical issues in biologics manufacturing.
+ Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
+ Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
+ Previous work experience where attention to detail and personal accountability were critical to success.
+ Demonstrates good interpersonal skills, is attentive and approachable.
+ Maintains a professional and productive relationship with area management and co-workers.
+ Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
CONTACTS:
+ The Manufacturing Technical Leads work in teams and interact with other teams, Quality Assurance, Manufacturing Technology, Materials Management, and Maintenance staff during the manufacturing process. They also have daily contact with their supervisory staff for work assignments and coaching. Technical Leads lead shift huddles with cross-functional team members and may have occasional contact with other line management staff for specific project responsibilities.
WORKING CONDITIONS:
+ Work is performed in a state-of-the-art large scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustic, and steam.
+ N ight Shift Rotation 5pm to 5am
DECISION MAKING:
+ Take action, final decision, recommend
+ May work on assignments that are extremely complex in nature where independent action and a high degree if initiative are required in resolving problems and developing recommendations.
SUPERVISION RECEIVED:
+ Incumbents act independently to determine methods and procedures on new assignments
SUPERVISION EXERCISED:
+ This role has no direct reports. In the absence of shift supervisor, the Technical Lead may modify the group work plan, schedule, or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, and regularly provides training and operational guidance to staff.
The above statements are intended to describe the general nature of work being performed by people assigned to these roles. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586531
Updated: 2024-10-25 02:04:30.417 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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. Read more: careers.bms.com/working-with-us .
MAJOR DUTIES AND RESONSIBILITIES:
+ Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. - striving for right first time through adherence of GMP activities.
+ Change control identifiers - works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation.
+ Communicate and resolve operational variances.
+ Serve as the acting Shift Supervisor/Manager in absence of Shift Supervisor/Manager - Coordinate, direct and oversee work execution and manage personnel related issues.
+ Executes real time process monitoring - including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions.
+ Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
+ Participate in performance review discussion.
+ Leads routine investigations in Infinity as a low-level lead investigator - drives technical issues working with cross functional team members.
+ Support complex investigations and CAPAs - author, review, approval, in case of excess investigation beyond planned capacity.
+ Actively involved in safety related GEMBA, safety 4-box and safe IM investigation.
+ Actively involved in coaching of team members to prevent human related error and quality events.
+ Supports issue escalation with key stakeholders, troubleshooting systems and equipment issues, and working collectively to drive resolution.
+ Support real time process reports review and resolve open issues. Trend issues and strives to right first time.
+ Execute and drive continuous improvements such as procedure updates in electronic document repository (DCA)
+ Supports Tech transfer team through active participation in ensuring that new process can fit and executes in a sustainable manner.
+ Assigned area owner - drive facility upkeep through escalation of service requests, area walkthroughs, safety escalations (SAFE IM) and generation of safety communications.
+ Adheres to Good Manufacturing Practices and standard operating procedures.
+ Weighs and checks raw materials. Assembles, cleans, and sterilizes process equipment, monitors processes.
+ Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
+ Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.). Regularly provides training and operational guidance to staff.
+ Effectively uses process automation systems (i.e., Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e., SAP, Infinity, Maximo etc.).
+ Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
+ Support mentoring and coaching of operators on safety, executing task with a quality mindset, and prioritizing daily task to drive schedule adherence.
+ Assists with the coordination and implementation of special projects such as validation, complex investigations, and protocol execution.
+ May provide scheduling and work assignment guidance to peers. Modifies group work plan, schedule, or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary.
+ May attend departmental meetings as area representative (Schedule Review, Operations Huddle, Frozen, etc.).
+ Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action.
KNOWLEDGE AND SKILL:
+ B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
+ A minimum of 5+ year's process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
+ Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
+ Demonstrated experience in solving complex technical issues in biologics manufacturing.
+ Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
+ Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
+ Previous work experience where attention to detail and personal accountability were critical to success.
+ Demonstrates good interpersonal skills, is attentive and approachable.
+ Maintains a professional and productive relationship with area management and co-workers.
+ Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
CONTACTS:
+ The Manufacturing Technical Leads work in teams and interact with other teams, Quality Assurance, Manufacturing Technology, Materials Management, and Maintenance staff during the manufacturing process. They also have daily contact with their supervisory staff for work assignments and coaching. Technical Leads lead shift huddles with cross-functional team members and may have occasional contact with other line management staff for specific project responsibilities.
WORKING CONDITIONS:
+ Work is performed in a state-of-the-art large scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustic, and steam.
+ N ight Shift Rotation 5pm to 5am
DECISION MAKING:
+ Take action, final decision, recommend
+ May work on assignments that are extremely complex in nature where independent action and a high degree if initiative are required in resolving problems and developing recommendations.
SUPERVISION RECEIVED:
+ Incumbents act independently to determine methods and procedures on new assignments
SUPERVISION EXERCISED:
+ This role has no direct reports. In the absence of shift supervisor, the Technical Lead may modify the group work plan, schedule, or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, and regularly provides training and operational guidance to staff.
The above statements are intended to describe the general nature of work being performed by people assigned to these roles. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586531
Updated: 2024-10-25 02:04:30.417 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
