Program Manager, Quality Control (Analytical Testing)
Apply NowCompany: Forge Biologics
Location: Columbus, OH 43230
Description:
About Forge
Forge Biologics, 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 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.
Summary:
We are currently seeking a Program Manager, Quality Control to join the Forge Biologics team. In this newly created role, the Program Manager will work as part of a cross functional team coordinating Quality Control Analytical Testing activities to support critical internal and client projects.
This position will support documentation and testing activities related to analytical method execution, stability programs, method qualification, and method validation for final products and raw materials. This role will also be responsible for fostering interdepartmental relationships, enabling the QC team to execute various projects supporting gene therapy product characterization and release. The QC Program Manager role will have the opportunity to significantly impact the success of client gene therapy programs.
What You'll Do:
What You'll Bring:
Nice To Have:
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) for extended periods of time. Employees regularly wear 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
Competitive paid time off plan
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)
Onsite fitness facility
Professional & Personal development resources
Forge Biologics, 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 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.
Summary:
We are currently seeking a Program Manager, Quality Control to join the Forge Biologics team. In this newly created role, the Program Manager will work as part of a cross functional team coordinating Quality Control Analytical Testing activities to support critical internal and client projects.
This position will support documentation and testing activities related to analytical method execution, stability programs, method qualification, and method validation for final products and raw materials. This role will also be responsible for fostering interdepartmental relationships, enabling the QC team to execute various projects supporting gene therapy product characterization and release. The QC Program Manager role will have the opportunity to significantly impact the success of client gene therapy programs.
What You'll Do:
- Lead project and routine business coordination of QC Analytical Testing activities, ensuring resources, documentation/deliverables, and schedules are in alignment across site efforts
- Work cross-functionally with Program Management, Planning, and Functional Teams including Manufacturing, Facilities & Engineering, Quality Engineering, Quality Management, Technology Services, and Supply Chain/Warehouse.
- Maintain and manage Projects, Quality Events, Analytical Testing Program Initiatives, and the QC documentation dashboard
- Provide progress updates around release and stability testing, communicating risks and opportunities to management
- Prepare updates for routine Leadership meetings, as required by Quality Management Leadership
- Support QC continuous improvement objectives, SOPs, and associated controlled documents (templates, forms, controlled lists, work instructions, etc.)
- As necessary, provide review and approval of Quality Control deliverables.
- QC deliverables to include, but not limited to, drafting of all testing documentation (SP, SPC, stability protocols, etc.), completion of routine and stability testing activities, lab investigation closure, and study reports
What You'll Bring:
- Bachelor's degree in a scientific field or related discipline.
- Project Management/Coordination experience within an FDA/EU regulated pharmaceutical, biotech, or related industry/manufacturing company
- Proficiency in Smartsheet, MS Project, PowerPoint, Word, Excel, Outlook, etc.
- Experience using electronic Quality Management Systems (e.g., Veeva)
- Working knowledge of laboratory systems
- Ability to communicate with respect to technical or project management issues.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Nice To Have:
- Familiarity with analytical testing equipment and processes
- Experience in the application of pre-clinical, clinical, and commercial cGMPs
- Cell & Gene Therapy Industry Experience
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) for extended periods of time. Employees regularly wear 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
Competitive paid time off plan
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)
Onsite fitness facility
Professional & Personal development resources