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Laboratory and Stability Program Manager

Forge Biologics

Forge Biologics

Operations
Columbus, OH, USA
Posted on Tuesday, June 25, 2024

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help 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 Laboratory and Stability Program Manager is responsible for coordination of client stability programs executed within the Quality Control (QC) department and ensuring that the laboratory spaces are operating efficiently. This position will work directly with QC Management to coordinate stability program documentation needs, material storage, testing pull dates, method execution, and COA/report creation. This role will oversee the coordination for the Quality Control team between vendors, clients, facilities, supply chain, and EHS. This role will also support coordination of laboratory training for staff, and equipment maintenance and calibration as needed.

What You'll Do

  • Defines client release and stability project/program requirements and identifies all elements of scheduling, cost, and technical performance. Develops and/or refines the resource structure to a level sufficient to identify all the work required for task or project completion.
  • Develop sample organization systems by partnering with QC team members to ensure proper location, clear results and logging of samples is accurate.
  • Partner with QC Management and testing staff to schedule and execute regular preventive maintenance checks for all laboratory instruments. Coordinate with F&E and external vendors for PM and calibrations.
  • Serves as the point of contact for both scientific and financial discussions with clients in both engineering and GMP testing. Establishes and maintains client relationships. Hosts client visits for programs and is adept at facilitating virtual meetings.
  • Coordinate material availability with Manufacturing/GMP, Process Development (PD), and Analytical Development (AD) department teams.
  • Manages cost, schedule and performance using standard program management tools such as Smartsheet. Assigns work to task team members while assessing scope, schedule and budget change requests and takes requisite action. Ensures that the task is maintained within the scope, budget, and schedule of the baseline agreement.
  • Works in collaboration with tech sales and QC management to initiate proposal preparation on Stability Programs or Laboratory Testing contracts. Translates the technical approach into the program’s schedule and budget.
  • Prepares and facilitates presentations to internal management and to external customers to provide reviews and updates on testing results and scheduling.
  • Identify and lead improvement opportunities as determined through department objectives, data analysis, user feedback, and other quality-related programs.
  • Actively manages risk using risk management fundamentals and terminology. Applies processes and procedures to identify, analyze, classify, and mitigate the prioritized project risks.
  • Applies safety standards and procedures to complete safety checks and verifies compliance with the safety plans of a task. Is knowledgeable regarding regulations and policies on workplace safety, and actively incorporates safe workplace practices into task work.
  • Stays abreast of Project Management best practices. Understands, embraces, and executes relevant Quality Systems and applicable industry regulations. Maintains a basic understanding of and ensures compliance with applicable government and industry regulations.
  • Assist in the development of business level goals & objectives, critical operating tasks, and client and process improvement plans.
  • Coordinate QC laboratory training with PD and AD staff.

What You'll Bring

  • Bachelor’s degree in biology, chemistry, a related discipline, or equivalent
  • Demonstrated project management skills with ability to work collaboratively with both internal and external counterparts on complex internal/external projects.
  • Multiple years of relevant experience in a pharmaceutical, biotechnology, or lab related environment
  • Experience with Smartsheet, Microsoft Excel & Powerpoint, Electronic Lab Notebook System (ELN), Veeva QMS, and Laboratory Information Management Systems (LIMS)
  • Excellent communication and organizational skills

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) 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
  • 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