Analytical Quality Control, Analyst I (2nd Shift) bei Forge Biologics

Summary:

We are currently seeking a Quality Control (QC) Analyst I, Analytical Testing, to join the Forge Biologics team. This role will perform characterization and release testing QC for AAV vectors, plasmids, and cell banks, while maintaining meticulous records and ensuring the accuracy of data for all products. This position is responsible for routine test method execution, assisting in method qualification and validation, instrumentation troubleshooting, and data analysis. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector. The Analyst I role offers an excellent opportunity to gain hands-on experience in the field of gene therapy.

Shift Requirement:

This position is intended for Second Shift. However, to ensure a successful onboarding experience, the selected candidate will begin on First Shift for the initial training period, which is expected to last several months. After training is complete, the role will transition to its regular Second Shift schedule.

Responsibilities: 

• Performs in process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories 

• Performs raw materials testing to ensure they conform to manufacturer specifications 

• Provides Biochemistry and/or Molecular Biological expertise for the Forge GMP facility 

• Executes the procedures designed to demonstrate safety efficacy, and purity of the drug products under evaluations 

• Performs technical writing, routine testing, and all other associated activities.   

• Responsible for training, sampling, routine testing, method qualification/validations, and investigations.   

• Adheres to all GMP requirements, maintains a solid understanding of FDA/EMEA regulations, and interacts/communicates with Quality Management.   

• Supports the QC management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. 

• May be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular “platform” process for the entire AAV program portfolio 

Requirements: 

• Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline with 0-4 years of related experience 

• Experience in qPCR, ELISA, Western Blot, Cell Culture, and immunoassays is preferred 

• Proficiency with Microsoft Office 

• Excellent verbal and written communication skills 

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 

• Ability to work with a high attention to detail 

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 

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. 

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