Genezen
MFG Specialist II - Compliance (1st Shift) Lexington, MA
Genezen, Lexington, Massachusetts, United States, 02421
Manufacturing Specialist II - (1st Shift)
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. Job Summary
The MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. This position is located in Lexington, MA and reports to the MFG Compliance and Improvement Manager. Essential Job Functions
Primary responsibilities include the following: Practices and promotes safe work habits and adheres to safety procedures and guidelines Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change. Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events. Identifies and drives Manufacturing corrective and/or preventative actions. Provide Manufacturing support for tech transfers Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing. Participates on cross functional teams to drive complex manufacturing operations changes or improvements Supports document revisions and/or document management including batch production records and manufacturing procedures Performs training with staff on the floor Provides expertise for processing technology (chromatography, filtrations, digital systems, etc) Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance Reviews the work of others and provides feedback Creates and presents trending and metrics reports Participates in equipment start-up, commissioning, and validation activities Works in a manner that requires consistent exercise of discretion and judgment Special Job Requirements
Normally requires 2 to 3 years related industry or manufacturing experience with a Bachelor's degree. A Master's degree with 1 to 2 years' experience will be considered as also acceptable. Some experience with owning, investigating, and writing deviations, creating and executing CAPAs, and writing and managing Change Controls. Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures Some experience in biomanufacturing unit operations (USP and/or DSP) Good technical writing and oral communication skills Hands-on experience in writing and reviewing documentation Prior experience preferred performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc. and/or scientific methods Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned Knowledge, Skills and Experience
Education / Certifications / Licenses
Essential/Desired
High School Diploma Essential Bachelor's Degree in Life Sciences/Engineering Essential Master's Degree in Life Sciences/Engineering Desired On-the-Job Experience 3-4 years related industry experience Desired Skills / Abilities Ability to apply systems thinking as part of problem-solving Essential Demonstrates industrial empathy when working with stakeholders Essential Is detail oriented and able to self-organize Essential Is able to communicate in professional way on diverse levels and channels Essential Takes the initiative to own and resolve issues Essential 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 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 Genezen's Cures Value-Based Competencies
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in Action for the Patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in Operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions Driven for Our Partners We are committed to being a proactive, collaborative, creative and open-minded partner. Genezens Benefits
Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. Job Summary
The MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. This position is located in Lexington, MA and reports to the MFG Compliance and Improvement Manager. Essential Job Functions
Primary responsibilities include the following: Practices and promotes safe work habits and adheres to safety procedures and guidelines Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change. Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events. Identifies and drives Manufacturing corrective and/or preventative actions. Provide Manufacturing support for tech transfers Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing. Participates on cross functional teams to drive complex manufacturing operations changes or improvements Supports document revisions and/or document management including batch production records and manufacturing procedures Performs training with staff on the floor Provides expertise for processing technology (chromatography, filtrations, digital systems, etc) Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance Reviews the work of others and provides feedback Creates and presents trending and metrics reports Participates in equipment start-up, commissioning, and validation activities Works in a manner that requires consistent exercise of discretion and judgment Special Job Requirements
Normally requires 2 to 3 years related industry or manufacturing experience with a Bachelor's degree. A Master's degree with 1 to 2 years' experience will be considered as also acceptable. Some experience with owning, investigating, and writing deviations, creating and executing CAPAs, and writing and managing Change Controls. Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures Some experience in biomanufacturing unit operations (USP and/or DSP) Good technical writing and oral communication skills Hands-on experience in writing and reviewing documentation Prior experience preferred performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc. and/or scientific methods Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned Knowledge, Skills and Experience
Education / Certifications / Licenses
Essential/Desired
High School Diploma Essential Bachelor's Degree in Life Sciences/Engineering Essential Master's Degree in Life Sciences/Engineering Desired On-the-Job Experience 3-4 years related industry experience Desired Skills / Abilities Ability to apply systems thinking as part of problem-solving Essential Demonstrates industrial empathy when working with stakeholders Essential Is detail oriented and able to self-organize Essential Is able to communicate in professional way on diverse levels and channels Essential Takes the initiative to own and resolve issues Essential 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 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 Genezen's Cures Value-Based Competencies
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in Action for the Patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in Operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions Driven for Our Partners We are committed to being a proactive, collaborative, creative and open-minded partner. Genezens Benefits
Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision