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Bioprocess Technician II

2 months ago

East Norriton, United States Resilience Full time

 

 

A career at Resilience is more than just a job – it’s an opportunity to change the future.

 

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

 

For more information, please visit www.resilience.com

 

 

Position Summary & Role

The Technician II, Cell Therapy Manufacturing position is responsible for the hands-on clinical manufacturing of cell therapy product according to current Good Manufacturing Practices (cGMPs) and procedures.  The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process Development and report to the Bioprocess and Cell Therapy Supervisor.

Job Responsibilities

Leads small teams in the execution of individual activities / unit procedures associated with the manufacture of cell therapy products, using state-of-the-art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer).

Identifies in-process manufacturing deviations and escalates to the area lead and/or management.

Follows and executes batch records and standard operation procedures.

Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.

Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.

Performs delegated work assignments in a timely and complete manner.

Authors and maintains controlled documents including but not limited to SOPs, forms and batch records.

Assists with deviation investigations

Leads corrective/preventative action (CAPA) and Change Control (CC) implementation in the local Quality Management System (QMS).

Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.

Maintains manufacturing facility in a 5S and inspection-ready state.

Cross trains in other areas including Vector Manufacturing to perform additional job functions, as necessary.

Lead personnel training on individual equipment.

Must be able to work in setting with Biohazards and various Chemicals.

Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE).

Must be able to work in environment with variable noise levels.

Ability to stand, sit, and walk for long periods of time.

Ability to lift, push and pull 40 lbs. routinely.

Ability to crouch, bend, twist, and reach.   

Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.

Must be able to perform activities with repetitive motions.

Ability to climb ladders and stairs.

 

Minimum Qualifications

Direct experience in a GMP pharmaceutical manufacturing environment

Excellent oral and written communication skills.

Strong organization skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently.

Good attention to detail and ability to follow written procedures.

Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines. 

Preferred Experience, Education & Qualifications

Associates/Bachelor’s (science preferred) degree with 1-3 years of relevant or equivalent experience.

 

Other Ideal Personal Characteristics:

Reliable

Adaptable

Willingness to learn

Will occasionally require weekend, late evening, and overtime work to support scheduled and unscheduled cell therapy manufacturing operations.

 

 

 

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

 

 

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.