Project Manager, GMP Facilities & Validation

About Forge Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most. Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. About The Role The Facilities & Validation Project Manager at Forge Biologics plays a critical role in managing projects related to the growth and development of GMP facilities and systems. This role requires strong leadership, organizational, and communication skills to ensure projects are completed on time, within scope, and on budget. The Project Manager will work closely with cross-functional teams, stakeholders, and external partners, primarily collaborating with Forge's Facilities & Engineering, Manufacturing, Supply Operations, and Quality Validation Teams. The ideal candidate will have experience managing projects in GMP environment with a focus on equipment validation, facility release, and quality change controls. What You'll Do * Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets. * Lead project teams to meet quality and compliance standards, ensuring timely execution. * Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication, alignment on project goals, and effective issue resolution. * Manage project resources, including personnel, budget, and technology, to support project success. * Ensure adherence to quality standards, best practices, and compliance. * Maintain project documentation, including status reports, project charters, and other relevant documents, and provide regular updates to senior leadership and stakeholders. * Implement change management strategies and communicate project changes as needed. * Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of equipment and systems. * Oversee the validation process for critical systems, including HVAC, water systems, and production equipment to ensure all systems are compliant with GMP regulations and company SOP's. * Work closely with internal stakeholders, including Quality Assurance, Manufacturing, and Engineering teams, to ensure seamless project execution and compliance with GMP standards. * Identify potential risks associated with GMP facilities and systems projects and develop mitigation strategies to address these risks proactively. * Maintain detailed project documentation, including validation protocols, change controls, and status reports, ensuring all documentation meets regulatory and company requirements. * Drive continuous improvement initiatives related to GMP facilities and systems, identifying opportunities for process optimization. * Serve as the primary point of contact for all GMP facility and systems projects, providing regular updates to senior management and other stakeholders. What You'll Bring * 5+ years of project management experience within a GMP-regulated environment, ideally in CDMO or pharmaceutical manufacturing. * Strong knowledge of GMP regulations, particularly in facility and system validation. * Experience partnering with quality systems teams/function. * Proven experience managing complex, cross-functional projects. * Excellent communication, organizational, and problem-solving skills. * Ability to work independently and manage multiple priorities in a fast-paced environment. Preferred Skills * Knowledge of regulatory requirements for system validation (e.g., FDA, EMA). * Familiarity with Lean Six Sigma or other process improvement methodologies. * Project Management Certifications (e.g., PMP). Work Environment and Physical Demands This 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. 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. 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. Life at Forge We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by. HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key. OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback. PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies. ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals. We've Got You Covered We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable. * Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents * Flexible PTO (plus 14 paid company holidays) * Annual bonus for all full-time employees * 401(K) company match * Fully-stocked kitchen with free food/drinks * 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care * Employee Assistance Program * Wellness benefits (financial planning services, mental health counseling, employer paid disability) * Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches

Created: 2024-11-02