Building expert teams to advance science.

About the Role 

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

The Manufacturing Associate I will be responsible for assisting in the manufacturing of GMP products, Research Use Only products, and products for further manufacturing in controlled and un-controlled environments, utilizing guidance documents and batch records for process documentation. This individual shall assist in supporting core manufacturing requirements of the facility, including readying consumables, supporting and maintaining the in/outflow of critical manufacturing components, and contributing to document authorship. The Shift is 10:30am-7:00pm.

Why Rose BioSolutions 

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.

• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.

• Opportunities to grow your technical expertise and take ownership of your work.

• Close interaction with leadership and clients, enabling real influence on project outcomes

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• Participate in aseptic production of human primary cells within the cleanroom suite using accompanying documentation according to GMP guidelines. Verifies entered data by reviewing and sending for correction/reentry of data. Assist with preparing products for dispensing into bags and unit dose packaging.

• Performs tasks to prepare documentation for sampling site, incubator ID, batch number, and microbiological identification outside of clean room. Performs per-batch personnel monitoring on each sterile staff member. Performs weekly and per-batch environmental monitoring in sterile area(s). Reads and records the results.

• Labels blood products, including assigning labels and recording information

• Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and cleaning out-of-place (COP). Performs daily cleanings, monthly cleanings, and checks off on weekly cleanings, as well as ensuring removal of expired APIs.

• Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Maintain proper control of operations by following SOP’s, Manufacturing Procedures, GMP’s, ISO requirements, OSHA guidelines, and other pertinent regulatory requirements.

• Complies with all state and federal laws, rules, and regulations governing the practice of manufacturing and blood banking, including HIPAA. Stops at-risk behavior of others and self.

• Demonstrates thorough knowledge of the job, completing all annual competencies and skill validations, all initial and on-going validations, and advanced media-fill verifications, and continuously attains new knowledge. Prepare, perform, and report proficiency testing. Maintain the ability to a pass cleanroom gowning qualification and work within manufacturing cleanrooms as necessary.

• Use of the cell counter to generate QC data for in-process cleanroom operations. Record, interpret, review and report test results. Ability to use and analyze data from the flow cytometer for in-process cleanroom operations. Ability to recognize and investigate unacceptable test results.

• Ability to identify and aid in the investigation of deviations.

• Generate reports, store completed work in designated locations, and perform backup operations. Resolves discrepancies by using standard procedures or returning incomplete documents for resolution. Ability to review and complete all the documents/results needed for all the GMP product batch records.

• Tracks and maintains raw materials, gowning supplies, and other inventory for the maintenance of the cleanroom and other supportive areas. Responsible for inventory and ancillary supply restocking, expiration date checking, monitoring controlled environments, physical inventory, loading and unloading of various stock items.

• Performs maintenance and cleaning of cGMP/clean room areas. Assist all contractors to assure that work is done properly, and safety guidelines are observed. Supervise cleanroom maintenance work in or outside the cleanroom.

• Trains new staff as needed. Be able to train on new technologies and processes

• Perform some level of technology transfers with coordination and input of necessary stakeholders.

• Assists other technicians and/or staff as necessary, and completes any other duties designated by the supervisor.

• Identify and troubleshoot problems encountered in assigned tasks and properly document corrective actions. Inform supervisory staff of any recommendations for process improvement. Understands when to seek input and when to make independent judgments; prioritizes appropriately and makes productive use of time.

• In addition to the aforementioned tasks, perform/execute other duties as assigned

• Supervisory Responsibilities

• This position has no direct supervisory responsibility

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Meets department quality standards.

• Good time management skills: ability to complete assignments within established timelines.

Education, Experience, and Licensure

• High school diploma or equivalent required. College credits or college degree preferred.

• 1+ years of experience of clinical and/or pharmaceutical lab experience.

• Experience working within a GMP environment preferred.

• Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.

• Ability to quickly learn new software programs as needed.

Technical Skills

• Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.

• Ability to quickly learn new software programs as needed.

Language Skills

• Must have a good command of the English language and be able to communicate clearly and concisely in both written and verbal format.

Mathematical Skills

• Must be able to analyze and present quantitative data. Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.

Reasoning Ability

• Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise.

• Must be able to resolve issues of a general and routine nature and exercise appropriate judgment to escalate issues to senior management.

• Must be able to effectively prioritize routine and nonroutine work assignments to ensure goals and timelines are met.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

• Work is conducted in the Shipping, Laboratory, Donor Center, or standard office environment. Temperatures are regulated by facilities management and are not within the direct control of the individual or company. Most work is conducted in open areas with associated distractions such as noise from telephones, keyboards, machines, doorbells, and talking.

• Work performed in the Shipping, Laboratory, and Donor Center is done primarily while standing (6 to 8 hours a day). Work performed in the office environment is performed primarily while sitting (6 to 8 hours a day). All work environments utilize keyboards, gaze at a monitor(s), utilize hands to grasp, reach, and hold. The employee must frequently lift or move up to 10 pounds over their shoulder and occasionally lift or move up to 50 pounds. Staff who works in the Shipping / Logistics or Warehouse departments may be required to lift or move more than 50 pounds while using proper safety equipment.

• Exposure to standard chemicals used in an office environment is expected. Additional exposure to Shipping, Laboratory, and Donor Room staff includes exposure to water, chemicals, bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen. Refer to the Safety Data Sheets for a complete list.

• Staff must wear Personal Protective Equipment (PPE) when performing tasks that may expose to bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen or as required per policy.

• Employee must use proper safety equipment, as directed

Compensation Data:

The pay rate for this role is $26-$28 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. 

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.