Process Engineer, MS&T
Forge Biologics
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 Team
Manufacturing Science and Technology is a team of highly skilled Scientist responsible for the technology transfer of processes developed by Process Development into the GMP Manufacturing area. They are responsible for technical and scientific support for existing clients and internal production. The Manufacturing Science and Technology team develops and implements robust technology transfer, provides data analytics for existing processes and supports continuous improvement of cGMP Manufacturing. Manufacturing Science and Technology interacts with clients through the generation of reports, risk assessments and face to face meetings.
About The Role
As a Process Engineer at Forge Biologics, you will be responsible for developing, optimizing, and supporting gene therapy manufacturing processes within our Manufacturing Science and Technology (MS&T). This is a multidisciplinary position, and you will work closely with cross-functional teams, including R&D, manufacturing, quality, and regulatory teams, to ensure that upstream, downstream, and fill finish processes are scalable, robust, and compliant with regulatory requirements. This role focuses on feasibility evaluation, design, implementation, and documentation of engineering studies to support continuous improvement of processes towards the goals of process validation and the commercial manufacturing of gene therapy products. Process Engineering also provides technical support and troubleshooting for assigned processes and equipment in the cGMP biological manufacturing areas, ensuring that all improvements are sustainable and aligned with overall business goals.
What You’ll Do
- Provide technical support for process improvement and technology transfer activities involving cross-functional teams including Manufacturing, Quality, and Process Development, including upstream production, downstream purification, final formulation, and aseptic drug product filling.
- Identify and implement continuous process optimizations, automation, new technology, critical reagents, and material selection initiatives to drive operational efficiency, reduce costs, and enhance product consistency.
- Partner with clients and internal cross functional teams in technology transfer plans, gap analysis, mapping of process flows, and PFMEAs to ensure smooth and efficient technology transfer of gene therapy processes into manufacturing.
- Assist in the development of project justification, engineering proposals, and capital planning processes, including drafting URS and SIA documentation, facilities and equipment selection, and development of maintenance and training plans.
- For new equipment, may participate and/or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and IQ/OQ/PQ.
- Support for process qualification and validation preparation, execution, monitoring, and reporting.
- Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
- Develop and maintain external technical relationships with equipment and material suppliers to assist in the scheduling of training, repairs, maintenance of manufacturing equipment and to procure supplies and spare parts.
- Support the development of technical documents such as study plans, manufacturing batch records, and SOPs, protocols, and reports.
- Assist in investigations, document findings and maintain accurate records of all investigations, ensuring timely resolution of deviations.
- Additional responsibilities not listed may be assigned as needed by managemen
What You’ll Bring
- Bachelor’s degree, in life sciences, engineering or related field and 3+ years of industry experience; Masters degree with 2+ years of experience; PhD and 1+ years of experience
- Strong understanding of GMP, deviation management, change control processes, and continuous improvement methodologies.
- Working understanding of the overall bioprocessing workflow including upstream cell culture, bioreactors, chromatography, centrifugation, ultrafiltration, process analytics, data analysis, various lab and bioprocess equipment.
- Excellent verbal and written communication skills, with the ability to effectively interact with cross-functional teams.
- Strong scientific and engineering aptitude, including demonstrated experience in post-experimental data analysis and data-driven decision making.
- Excellent attention to detail and ability to accurately document and record experimental data and manufacturing activities.
- Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
- Ability to adapt to changing priorities and work effectively under pressure.
Preferred Skills
- In-depth understanding of cGMP manufacturing, Quality, and regulatory regulations in a biologics Pharma/ Biotech industry.
- Experience in Process Development, Manufacturing, and/or Manufacturing Science and Technology (MS&T) for cell or gene therapies.
- Working knowledge of industry systems (ERP, Veeva), statistical tools (JMP, SIMCA), and advanced experience with business software (i.e. Excel, Visio).
- Experience in training and developing manufacturing personnel to enhance their skills and knowledge.
Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) occasionally. Employees may need to wear clean room gowning or personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
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