QC Scientist Analytical Method Validation - Genezen : Job Details

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 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 Manger 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 EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/Desired BS or MS in Chemistry/Biochemistry or other related Life Sciences Essential ON-THE-JOB EXPERIENCE 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 COMPETENCIESCommitted 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. GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 9 observed holidays + 1 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&D) Insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museumto name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.