Job Title: Cell Therapy Operator/Res. Associate
Date: January 16, 2025
FLSA Status: Full-Time/Exempt
Manager: Director, Product Development
Departent: Product Development
Location: Pittsburgh
Job Code: BSB-25-004
BlueSphere is a Pittsburgh-based immunotherapy company developing novel T-cell therapies to treat individuals diagnosed with liquid and solid tumors. The established proprietary platform technologies in Neoantigen and tumor-specific TCR discoveries have provided a rich foundation for various TCR-T cell therapy pipelines and cancer vaccines to address unmet medical needs in both blood and solid tumors.
The Research & Development (R&D) organization at BlueSphere Bio aims to accelerate the translation of innovative research discoveries into new cancer therapeutic medicines by collaborating with CMC, clinical, and business development functions.
The Development team is looking for a motivated team member to join the fast-paced group and contribute to the process and analytical activities to take our TCR products into clinical production. We are looking for someone interested and eager to learn cutting-edge technologies and assist in the tech transfer and production of the products.
Responsibilities
- The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the level of training and experience of the employee
- Work is primarily in Grade B and Grade C aseptic manufacturing environments but may also include support of process development runs in the Manufacturing Science and Technology laboratory
- Performs cell manufacturing-related activities while wearing clean room attire in an aseptic cGMP manner
- SME on unit operations
- Documents production operations in corresponding batch records and log books per established procedures, ensuring accuracy and timely completion
- Identifies real-time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner
- Inputting and uploading of manufacturing data in real-time to the existing database
- Works with the Quality team to author out-of-specification (OOS) reports, deviation investigations and corrective and preventative actions
- Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned
- Handles human blood and human blood-based product intermediates; Helps with warehouse management, critical reagents and material inventory reports
- Review of Batch Records and logbooks / comment resolution
- Work on project teams (continuous improvement initiatives)-
- Organize and support process development studies in the PD laboratory
- Train new or junior employees on equipment and unit operations
- This is a start-up situation, so schedules and shifts will change over time
- Other duties as assigned
- Title may vary with experience
Qualifications
- Bachelor’s or Master’s degree in a cell biology, bioengineering, or medical technology-related field, or equivalent experience is required
- Ability to work flexible hours with some night and weekend availability is required
- Ability to stand for multiple hours and lift 20 pounds
- Excellent verbal and written communication skills are required
- Computer literacy is required, including Microsoft Outlook, Word, Excel, and PowerPoint
- 0-5 years’ experience working within cGMP regulated environment, including Good Documentation Practices (GDP)
- 0-5 years’ of research laboratory experience
- Experience with Mammalian Cell Culture
Physical and Mental Requirements
- You will be expected to occasionally (1% to 20% of the time):
- Climb stairs, ramps, ladders. Etc.
- Stoop/crouch by bending your legs or bending down/forward at the waist
- Reach by extending the hands/arms
- Lift objects from one level to another (30 lbs. or less)
- Carry objects (30 lbs. or less)
- Travel (up to 20%)
- You will be expected to frequently (21% to 50% of the time):
- Walk around the facility on foot
- Stand on your feet
- You will be expected to constantly (at least 51% of the time):
- Sit in a normal seated position
BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.
