Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)
Forge Biologics · Columbus, OH, United States
About The Role
<p><strong>Forge Your Future with Us:</strong></p>
<p>At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.</p>
<p>Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.</p>
<p>What sets Forge apart is our culture of <strong>H.O.P.E.</strong> We are <strong>hardworking</strong>, showing up each day with determination and grit. We are <strong>open</strong>, creating a space where ideas flow freely, and every voice is valued. We are <strong>purpose-driven</strong>, with every task directly tied to changing lives. And we are <strong>engaged</strong>, energized by the challenges we face and the milestones we achieve together.</p>
<p>At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.</p>
<p>If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.</p>
<p><strong>About The Role: </strong></p>
<p><span class="TextRun SCXW113267225 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW113267225 BCX0">The</span></span><span class="TextRun MacChromeBold SCXW113267225 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW113267225 BCX0"> <strong>Associate Manager, Quality Assurance - AAV </strong></span><strong><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW113267225 BCX0">Manufacturing</span></strong></span><span class="TextRun SCXW113267225 BCX0" lang="EN-US" data-contrast="none"> <span class="NormalTextRun SCXW113267225 BCX0">is responsible for</span><span class="NormalTextRun SCXW113267225 BCX0"> the </span><span class="NormalTextRun SCXW113267225 BCX0">supervision and development</span><span class="NormalTextRun SCXW113267225 BCX0"> of</span><span class="NormalTextRun SCXW113267225 BCX0"> junior members of</span><span class="NormalTextRun SCXW113267225 BCX0"> the Quality Assurance team </span><span class="NormalTextRun SCXW113267225 BCX0">and helping oversee AAV GMP manufacturing activities</span><span class="NormalTextRun SCXW113267225 BCX0">. The </span><span class="NormalTextRun SCXW113267225 BCX0">Associate Manager</span><span class="NormalTextRun SCXW113267225 BCX0"> will provide </span><span class="NormalTextRun SCXW113267225 BCX0">expertise</span><span class="NormalTextRun SCXW113267225 BCX0"> and guidance</span><span class="NormalTextRun SCXW113267225 BCX0">,</span> <span class="NormalTextRun SCXW113267225 BCX0">ensuring compliance with regulatory requirements and </span><span class="NormalTextRun SCXW113267225 BCX0">maintaining</span><span class="NormalTextRun SCXW113267225 BCX0"> the highest quality standards</span><span class="NormalTextRun SCXW113267225 BCX0">. </span><span class="NormalTextRun SCXW113267225 BCX0">The </span><span class="NormalTextRun SCXW113267225 BCX0">Associate</span><span class="NormalTextRun SCXW113267225 BCX0"> Manager</span><span class="NormalTextRun SCXW113267225 BCX0"> will </span><span class="NormalTextRun SCXW113267225 BCX0">supervise junior members of </span><span class="NormalTextRun SCXW113267225 BCX0">the Quality Assurance team in activities such as </span><span class="NormalTextRun SCXW113267225 BCX0">document control, batch record review, and </span><span class="NormalTextRun SCXW113267225 BCX0">maintain</span><span class="NormalTextRun SCXW113267225 BCX0">ing</span><span class="NormalTextRun SCXW113267225 BCX0"> a QA presence in AAV gene therapy manufacturing areas.</span></span><span class="EOP Selected SCXW113267225 BCX0" data-ccp-props="{}"> </span></p>
<p><strong>Responsibilities:</strong></p>
<ul>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Serve as a quality resource for the GMP AAV Manufacturing department directly overseeing operations in the cleanroom manufacturing environment,</span> <span data-ccp-parastyle="List Bullet">providing guidance and effective communication of Quality issues that arise during the manufacturing of product by making make fact-based, data driven, compliant decisions regarding products and process. </span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Provide supervision for employee relations through effective communication, coaching, </span><span data-ccp-parastyle="List Bullet">training</span><span data-ccp-parastyle="List Bullet"> and development and </span><span data-ccp-parastyle="List Bullet">eliminate</span><span data-ccp-parastyle="List Bullet"> roadblocks for the team to move forward.</span> <span data-ccp-parastyle="List Bullet">Assist</span><span data-ccp-parastyle="List Bullet"> management in setting </span><span data-ccp-parastyle="List Bullet">clear vision</span><span data-ccp-parastyle="List Bullet"> by ensuring goals and </span><span data-ccp-parastyle="List Bullet">objectives</span><span data-ccp-parastyle="List Bullet"> are aligned with departmental goals and supervising each junior team member’s team </span><span data-ccp-parastyle="List Bullet">support. </span><span data-ccp-parastyle="List Bullet">Oversee</span><span data-ccp-parastyle="List Bullet"> timecard reporting, task oversight, and scheduling.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to </span><span data-ccp-parastyle="List Bullet">established</span><span data-ccp-parastyle="List Bullet"> procedures and cGMP regulations.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality </span><span data-ccp-parastyle="List Bullet">objectives</span><span data-ccp-parastyle="List Bullet">.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Support the documentation control process for AAV gene therapy manufacturing, including creation, revision, review, and approval of batch records, SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Support deviations and continuous improvements related to AAV gene therapy manufacturing processes, </span><span data-ccp-parastyle="List Bullet">assist</span><span data-ccp-parastyle="List Bullet"> with root cause analysis and identification of CAPA measures to prevent recurrence.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Assist</span><span data-ccp-parastyle="List Bullet"> in the preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">6</span><span data-ccp-parastyle="List Bullet">+</span><span data-ccp-parastyle="List Bullet"> years in a </span><span data-ccp-parastyle="List Bullet">Q</span><span data-ccp-parastyle="List Bullet">uality </span><span data-ccp-parastyle="List Bullet">A</span><span data-ccp-parastyle="List Bullet">ssurance </span><span data-ccp-parastyle="List Bullet">or related </span><span data-ccp-parastyle="List Bullet">role within the pharmaceutical or biotechnology industry</span><span data-ccp-parastyle="List Bullet">.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Experience mentoring and developing junior team members, including providing guidance on </span><span data-ccp-parastyle="List Bullet">QA</span><span data-ccp-parastyle="List Bullet"> best practices and fostering professional growth.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Thorough understanding of pharmaceutical </span><span data-ccp-parastyle="List Bullet">cGMP</span><span data-ccp-parastyle="List Bullet"> requirements and strong working knowledge of FDA and EU requirements/guidance documents.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="none">Experience using an Electronic Quality Management System, preferably Veeva Vault or a comparable document management platform. </span><span data-ccp-props="{}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Ability to collaborate with cross-functional technical groups to resolve issues, close </span><span data-ccp-parastyle="List Bullet">gaps,</span><span data-ccp-parastyle="List Bullet"> and ensure compliant outcomes which are efficient and robust.</span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="none">Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance. </span><span data-ccp-props="{}"> </span></li>
<li><span data-contrast="none">Proficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint. </span><span data-ccp-props="{}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Calibri",469777842,"Times New Roman",469777843,"Calibri",469777844,"Calibri",469769226,"Calibri,Times New Roman",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Ability to work the hours necessary to support production and </span><span data-ccp-charstyle="normaltextrun">participate</span><span data-ccp-charstyle="normaltextrun"> in an on-call rotation providing off-hours support for AAV manufacturing needs and issues.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Ability to work in a GMP cleanroom environment </span><span data-ccp-charstyle="normaltextrun">as</span><span data-ccp-charstyle="normaltextrun"> needed to support manufacturing operations, including wearing required PPE such as gowns, gloves, masks, and safety glasses.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<p><strong>Preferred Skills:</strong></p>
<ul>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment. </span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Experience working in the production of biologics (ex. gene therapies). </span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Familiarity with CDMO operations and client-driven project timelines. </span></span><span data-ccp-props="{"335559738":30,"335559739":30}"> </span></li>
<li><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Experience supporting internal audits and </span><span data-ccp-charstyle="normaltextrun">participating</span><span data-ccp-charstyle="normaltextrun"> in external audits or inspections.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<p><em>This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.</em> </p>
<p><strong>Work Environment and Physical Demands </strong> </p>
<p><span class="TextRun SCXW15796509 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW15796509 BCX0" data-ccp-parastyle="paragraph" data-ccp-parastyle-defn="{"ObjectId":"aaed607e-c2a3-5841-9fb4-41037bfa0faf|1","ClassId":1073872969,"Properties":[268442635,"24",469777841,"Times New Roman",469777842,"Times New Roman",469777843,"Times New Roman",469777844,"Times New Roman",469769226,"Times New Roman",469775450,"paragraph",201340122,"2",134233614,"true",469778129,"paragraph",335572020,"1",134233118,"true",134233117,"true",469778324,"Normal"]}">This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.</span></span><span class="EOP Selected SCXW15796509 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p>
<p>Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. </p>
<p><strong>We’ve Got You Covered: </strong></p>
<p>At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:</p>
<p><strong>Health from day one</strong></p>
<ul>
<li>Health, dental and vision insurance start your first day – with 90% of premiums covered for you <em>and</em> your family.</li>
</ul>
<p><strong>Time to recharge</strong></p>
<ul>
<li>A competitive paid time off plan – because rest fuels innovation.</li>
<li>12 weeks of fully paid parental leave so you can focus on family when it matters most.</li>
</ul>
<p><strong>Rewarding your impact</strong></p>
<ul>
<li>Annual bonus opportunities for all full-time team members.</li>
<li>401(k) with company match to help you plan for the future.</li>
<li>Special employee discounts, including childcare and dependent care savings.</li>
</ul>
<p><strong>Your wellness, supported</strong></p>
<ul>
<li>Onsite fitness facility at The Hearth.</li>
<li>Mental health counseling and financial planning services through our Employee Assistance Program.</li>
<li>Employer-paid short and long-term disability coverage to protect your peace of mind.</li>
</ul>
<p><strong>Fuel for your workday</strong></p>
<ul>
<li>A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.</li>
</ul>
<p><strong>Grow with us</strong></p>
<ul>
<li>Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.</li>
</ul>
Similar roles you might like
See all →This is an external listing. JobSpring does not represent or verify the employer. Report this listing