{"id":784422,"url":"https://alion.io/job/forgebiologics-director-quality-control-raw-materials","title":"Director, Quality Control - Raw Materials","company":{"id":673246,"name":"Forge Biologics","domain":"forgebiologics.com","url":"https://alion.io/company/forgebiologics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Columbus, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":124000,"max_usd":241000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":628},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"ELISA","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"qPCR","optional":false}],"status":"closed","first_seen_at":"2026-08-31T14:31:20Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-22T16:08:24Z","board_verified":false,"closed_at":"2026-10-22T16:08:24Z","days_open":52,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":52},"description":"Forge Your Future with Us:\nAt 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.\nOur 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.\nWhat sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.\nAt 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.\nIf 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.\nSummary: \nWe are seeking a Director, Quality Control (Raw Materials) to join the Forge Biologics team. The Director of Quality Control (QC), Raw Materials (RM) will actively contribute to the strategic, operational, and laboratory activities required to support the development and management of the raw material testing program. The Director manages the QC Raw Materials department and will collaborate with internal Manufacturing, Supply Chain, Facilities, and Quality Senior Management, as well as external suppliers, to address quality-related issues. This role will also support continued development of phase-appropriate raw material qualification, laboratory readiness, external testing oversight, and inspection-ready quality systems to support pre-clinical, clinical, and commercial manufacturing activities. \nResponsibilities: \nProvides strategic and operational leadership to a Quality Control department responsible for raw material sample receipt, incoming inspection and testing, and release of all starting materials (raw materials, consumables, etc.). \nProvides strategic leadership and guidance to the organization to develop and implement a material qualification program in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities. \nRemains current on new technologies, and regulatory requirements that may have an impact on the company’s development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. \nAccountable for ensuring adherence to strict regulatory requirements to ensure product quality. \nContributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications. \nWorks directly with Leadership and Senior Management to ensure process communications are occurring in a timely manner, and budget and timelines are being adhered to. \nServe as a Subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices. \nParticipates in the Engineering effort (i.e., CAPEX) to assure analytical equipment and supporting materials are in place and meet GMP requirements from design through procurement, installation and operational readiness, and associated required documentation. \nCreate, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls. \nQualifications: \nBachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related discipline (Master’s Degree or PhD is preferred). \n8+ years of experience in leadership, management, or supervisory roles, preferably within the Gene Therapy/Cell Therapy industry. \nComprehensive experience with the analytical methods used for raw materials testing. \nExpert-level knowledge of raw material requirements described in global pharmacopeias such as USP, EP, JP, BP, Ph. Eur. \nWorking knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques. \nExpert-level knowledge of CMC analytical and regulatory requirements. \nExpert-level knowledge of cGMP requirements as they pertain to Quality Control raw material testing. \nDemonstrated experience in departmental budgeting, CAPEX procurement, IQ/OQ, safety, and status reporting to Leadership and Senior Management. \nAbility to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. \nAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. \nAbility to present to and interact with Leadership and Senior Management. \nAbility to work hours necessary to support production and/or product transfer activities. \nPreferred: \nExperience starting up, scaling, or managing multiple QC laboratories or testing groups, including release, stability, raw materials, primary packaging, printed materials, and in-process testing. \nHands-on or leadership experience with analytical instrumentation troubleshooting, laboratory equipment qualification, computerized laboratory systems, and implementation of new technologies or laboratory workflows. \nExperience in high-level interactions with domestic and international Regulatory agencies. \nExperience building, managing, or improving QC raw material programs, GMP testing operations, laboratory readiness activities, or supplier/material qualification processes. \nExperience with laboratory quality systems, including OOS/OOT investigations, deviations, CAPAs, change controls, data integrity expectations, and inspection readiness activities. \nExperience working with external contract laboratories, outsourced testing, supplier quality issues, method alignment, or material specification lifecycle management. \nASQ certification, Lean/Six Sigma certification, or other relevant quality, laboratory, or operational excellence credential. \nThis 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. \nWork Environment and Physical Demands \nThis position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs. \nForge 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. \nWe’ve Got You Covered: \nAt 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:\nHealth from day one\nHealth, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.\nTime to recharge\nA competitive paid time off plan - because rest fuels innovation.\n12 weeks of fully paid parental leave so you can focus on family when it matters most.\nRewarding your impact\nAnnual bonus opportunities for all full-time team members.\n401(k) with company match to help you plan for the future.\nSpecial employee discounts, including childcare and dependent care savings.\nYour wellness, supported\nOnsite fitness facility at The Hearth.\nMental health counseling and financial planning services through our Employee Assistance Program.\nEmployer-paid short and long-term disability coverage to protect your peace of mind.\nFuel for your workday\nA fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what’s next.\nGrow with us\nOngoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.","description_format":"text","description_chars":9357,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Natural Resources","Cell & Gene Therapy","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-09-12T01:26:52Z"},{"event":"close","at":"2026-10-22T16:08:24Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":7,"green_card_filings_12m":0,"median_offered_wage_usd":107500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":null,"pay":null,"html_url":"https://alion.io/job/forgebiologics-director-quality-control-raw-materials","json_url":"https://alion.io/job/forgebiologics-director-quality-control-raw-materials.json","meta":{"generated_at":"2026-10-24T23:18:31Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":34289,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":673246},"rest":"https://alion.io/mcp/rest/get_company?id=673246"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fforgebiologics-director-quality-control-raw-materials"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fforgebiologics-director-quality-control-raw-materials"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fforgebiologics-director-quality-control-raw-materials"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/forgebiologics-director-quality-control-raw-materials\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fforgebiologics-director-quality-control-raw-materials"}]}