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Sr. Analyst II, Quality Control (Flow Cytometry)

Employer
Resilience
Location
East Norriton, PA
Start date
Jun 11, 2024

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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:

Resilience seeks an Senior Analyst II, Quality Control (QC) supporting the QC Analytical department. The successful candidate will not only perform activities for routine release testing and stability samples of cell therapy products, but will also contribute to Assay Qualification and Validation.

The Sr. Analyst II, Quality Control will partner with Manufacturing and QC and QA operations teams to ensure that all required testing is performed, meeting all partner needs in compliance with standard operating procedures and testing methods.

The Sr. Analyst II, Quality Control will act as a Flow Cytometry Subject Matter Expert (SME) for the QC Analytical team and will troubleshoot and provide support to other team members, as needed.

Position Responsibilities:

  • Perform routine sample analysis in support of manufacturing release and stability activities.

  • Sample testing of cell therapy products using protein-based assays, molecular methods, and cellular assays.

  • Participate in method transfer/qualification/validation activities as assigned by QC management.

  • Support Flow Cytometry methods troubleshooting and investigations.

  • Analyze, document, and report experimental data in accordance with Resilience requirements.

  • Perform general laboratory maintenance activities per established schedule.

  • Maintain, calibrate, and operate analytical equipment; Qualify equipment related to testing, as necessary.

  • Review data, identify discrepancies, and escalate issues to management

  • Author SOPs, methods, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use.

  • Investigate OOS or OOT events and develop/implement preventive and corrective actions.


Minimum Qualifications:

  • Knowledge of general analytical methods;

  • Experience in Flow Cytometry methods;

  • GLP or GMP experience required

  • Ability to thrive in ambiguous or complex situations

  • Highly motivated and self-directed

  • Thrives in matrix environment

  • Excellent interpersonal, verbal and written communication skills


Preferred Qualifications:

  • BS in relevant discipline (immunology, cell biology, or related field) with 2-5 years of relevant experience in life science field

  • Experience in mammalian cell culture

  • Background in Cell Therapy/Gene Therapy


This position may also include the following conditions:

  • Visual acuity

  • All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role


The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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 $100,000.00 - $137,500.00 per year. 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.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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