Genezen
QC Scientist Analytical Method ValidationLexington, MA
Genezen, Lexington, Massachusetts, United States, 02421
Qc Scientist Analytical Method Validation
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. Working at Genezen 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 QC Scientist Analytical Method Validation is a key role within our Quality Control Technical Services (QCTS) department. The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines. Essential Job Functions Works under guidance of QC Manager responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production Writes protocols and reports related to QC Method transfer, qualification, feasibility and validation May assist in writing protocols or participate in instrument qualifications Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements Assist with data trending and aid in compilation of trend reports Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting Present to cross-functional teams and effectively communicate critical analytical issues and solutions Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, PCR / qPCR, ELISA, Potency Assay, SDS-PAGE and western blot) and/or viral vector manufacturing Familiar with FDA and EMA guidance documents relevant to gene therapy Working knowledge of quality systems requirements Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Demonstrated leadership skills and the ability to collaborate with and effectively influence others Establish, revise, review and maintain procedures (including protocol and technical report) Assure that laboratory procedures are current and facilitate updates as required As applicable perform routine/non-routine testing of in-process, final product in accordance with Standard Operating Procedures (e.g., Q-PCR, Potency Assay, Western Blot, Refractometry, ELISA, etc.) as needed Complete documentation in accordance with current Good Manufacturing Practices (cGMP) Maintain QC lab and related systems to ensure compliance with industry standards Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency Troubleshoot equipment and analytical testing methods Training of other QC Analysts within the department Special Job Requirements 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 BS or MS in Chemistry/Biochemistry or other related Life Sciences Essential Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer. Essential Prior experience with analytical method validations, analytical data trending/statistical analysis Essential Understanding of QC instrument qualification is preferred. Desired Thorough understanding of industry testing requirements/standards Desired Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential. Essential Thorough understanding of industry testing requirements/standards related to gene/cell therapy products. Essential Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy Desired Working knowledge of quality systems requirements Desired Skills / Abilities Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) Essential Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential Essential Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Essential Proven demonstration of technical writing skills such as protocol, reports, procedures etc. Essential Effective project management and presentation skills Desired Good/effective communication and organizational skills with the ability to work well with others and independently Desired Ability to work collaboratively with cross functional departments Desired Physical Demands While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels 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 25 pounds Occasionally lift and/or move up to 50 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 Urgency in Action for the Patients Resilience & Grit in Operations Execute with Excellence & Integrity Solutions Driven for Our Partners Genezen's 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 care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD
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. Working at Genezen 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 QC Scientist Analytical Method Validation is a key role within our Quality Control Technical Services (QCTS) department. The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines. Essential Job Functions Works under guidance of QC Manager responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production Writes protocols and reports related to QC Method transfer, qualification, feasibility and validation May assist in writing protocols or participate in instrument qualifications Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements Assist with data trending and aid in compilation of trend reports Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting Present to cross-functional teams and effectively communicate critical analytical issues and solutions Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, PCR / qPCR, ELISA, Potency Assay, SDS-PAGE and western blot) and/or viral vector manufacturing Familiar with FDA and EMA guidance documents relevant to gene therapy Working knowledge of quality systems requirements Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Demonstrated leadership skills and the ability to collaborate with and effectively influence others Establish, revise, review and maintain procedures (including protocol and technical report) Assure that laboratory procedures are current and facilitate updates as required As applicable perform routine/non-routine testing of in-process, final product in accordance with Standard Operating Procedures (e.g., Q-PCR, Potency Assay, Western Blot, Refractometry, ELISA, etc.) as needed Complete documentation in accordance with current Good Manufacturing Practices (cGMP) Maintain QC lab and related systems to ensure compliance with industry standards Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency Troubleshoot equipment and analytical testing methods Training of other QC Analysts within the department Special Job Requirements 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 BS or MS in Chemistry/Biochemistry or other related Life Sciences Essential Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer. Essential Prior experience with analytical method validations, analytical data trending/statistical analysis Essential Understanding of QC instrument qualification is preferred. Desired Thorough understanding of industry testing requirements/standards Desired Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential. Essential Thorough understanding of industry testing requirements/standards related to gene/cell therapy products. Essential Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy Desired Working knowledge of quality systems requirements Desired Skills / Abilities Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) Essential Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential Essential Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Essential Proven demonstration of technical writing skills such as protocol, reports, procedures etc. Essential Effective project management and presentation skills Desired Good/effective communication and organizational skills with the ability to work well with others and independently Desired Ability to work collaboratively with cross functional departments Desired Physical Demands While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels 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 25 pounds Occasionally lift and/or move up to 50 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 Urgency in Action for the Patients Resilience & Grit in Operations Execute with Excellence & Integrity Solutions Driven for Our Partners Genezen's 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 care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD