JOB SUMMARY

Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.

With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. 

This position is located in Lexington, MA and reports to the MFG Supervisor.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.

Primary responsibilities include the following:

• Attend daily meetings including shift hand off and ensure relevant information is shared between shifts
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state 
• Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
• Demonstrating general knowledge of aseptic techniques 
• Perform troubleshooting activities according to SOPs 
• Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed
• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms   
• Perform page reviews in BPRs, SLRs, Logbooks, and Forms  
• Carry out work in a safe manner, notifying management of safety issues and risks 
• Maintain up-to-date training folder for applicable processes 
• Required to work holidays and overtime as needed to support the manufacturing process

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment 
• Perform standardization of equipment 
• Support product change over activities 
• Support equipment and process qualifications if needed 
• Escalate work requests to Senior or Lead Technicians for submission in work request management system 

Staff Technical Training and Development:

• Propose continuous improvement, process, and human performance document revisions
• Escalate and contributes to process improvement and manufacturing Continuous Improvement items
• Develop and maintain personal development plan
• Provide annual performance self-assessment

SPECIAL JOB REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP
• Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization  
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures  
• Hands-on experience in writing and reviewing documentation  
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills  
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods
• Comfortably able to lift up to 40lbs  
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 20 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 2:00-10:30pm. The Supervisor will report to the Director of Manufacturing and Compliance.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.
• Oversee external GMP cleaning team's training and activities to ensure compliance with internal procedures.

JOB QUALIFICATIONS

• Prior leadership experience in GMP manufacturing facility
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Experience completing moderate to complex schedules
• Hands -on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

Compensation: 

The compensation range for this position is $105,000-$130,000 dependent upon experience level of the successful candidate. 

Work Environment:

• Regularly sit for long periods of time

Movement:

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting:

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication:

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will report to the Manufacturing Manager.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.

JOB QUALIFICATIONS

• Prior leadership experience in GMP manufacturing facility
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Experience completing moderate to complex schedules
• Hands -on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

Compensation: 

The compensation range for this position is $105,000-$130,000 dependent upon experience level of the successful candidate. 

Work Environment:

• Regularly sit for long periods of time

Movement:

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting:

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication:

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.

With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. 

This position is located in Lexington, MA and reports to the MFG Supervisor.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.

Primary responsibilities include the following:

• Attend daily meetings including shift hand off and ensure relevant information is shared between shifts.
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state 
• Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
• Demonstrating general knowledge of aseptic techniques 
• Perform troubleshooting activities according to SOPs 
• Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed.
• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms   
• Perform page reviews in BPRs, SLRs, Logbooks, and Forms  
• Carry out work in a safe manner, notifying management of safety issues and risks 
• Maintain up-to-date training folder for applicable processes 
• Required to work holidays and overtime as needed to support the manufacturing process

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment 
• Perform standardization of equipment 
• Support product change over activities 
• Support equipment and process qualifications if needed 
• Escalate work requests to Senior or Lead Technicians for submission in work request management system 

Staff Technical Training and Development:

• Propose continuous improvement, process, and human performance document revisions
• Escalate and contributes to process improvement and manufacturing Continuous Improvement items.
• Develop and maintain personal development plan
• Provide annual performance self-assessment

SPECIAL JOB REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization  
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures  
• Hands-on experience in writing and reviewing documentation  
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills  
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods
• Comfortably able to lift up to 40lbs  
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 20 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail