Senior Specialist II, Technical Quality at Resilience

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

Come join the enthusiastic and collaborative Technical Quality (TQ) team to contribute to the overall success of our novel gene therapies. This position will support the TQ organization through coaching/guidance and quality oversight review, and approval of internal protocols and reports related to process manufacturing and laboratory equipment qualification, technology transfer, and process validation. These activities will encompass IND-enabling, pre-clinical, clinical, and commercial projects.

Primary Responsibilities

• Provide guidance, review, and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
• Provide hands-on support and guidance during internal, regulatory, and customer inspections.
• Works closely with all site functional teams (Manufacturing, MSAT, Engineering, QC, CSV, CQV, etc.) responsible for protocol development and execution to provide Technical and Quality support and oversight.
• QA Approval of change controls, deviations, CAPA’s, and validation lifecycle documents (e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements).
• Represent the Technical Quality group in project teams, audits, and inspections, as required.
• Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
• Drive the revision of policies standards and procedures to support quality systems, as required.
• Exercise judgment within and outside of defined procedures and practices to determine appropriate action.
• Provide Technical QA support, input, and oversight for the manufacturing site for validation activities including:
  • Computer Systems Validation
  • Process Validation
  • Analytical instrument qualification, use and maintenance
  • Equipment Utilities
  • Facilities commissioning, qualification, use and maintenance
  • Validation of Cleaning
  • Sterilization
  • Decontamination processes
  • Aseptic Process Simulation
  • Technology Transfers

Minimum Qualification

• Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer and process validation, and/or Quality oversight in these disciplines.
• Thorough knowledge of current industry practices and regulatory guidance expectations regarding qualification, technology transfer,and validation.
• Strong leadership, relationship management, and organizational planning.
• Experience supporting internal and regulatory inspections
• Experience using risk-based approaches (QRM, FMEA, PHA, etc.).
• Ability to make independent sound decisions and independently manage priorities in alignment with department and site priorities.
• Ability and willingness to learn and adapt skills for various areas
• Independently motivated, detail-oriented, and good problem-solving ability in both teams and as an individual contributor.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Ability to travel approximately 5-10% based on project demand.
• Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

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Preferred Qualifications

• Minimum of 8 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment (FDA, EMA, MHRA).
• Bachelor's degree in Life Sciences, or Engineering and/or equivalent industry experience.
• Knowledgeable of Data Integrity requirements.
• Prior cGMP cell or gene therapy and/or aseptic fill/finish manufacturing experience is highly desired.
• Strong analytical ability
• Experience within a multi-product facility is a plus.
• Exercise judgment within and outside of defined procedures and practices to determine appropriate action.
• Ability to multitask and prioritize independently in a fast-paced environment.
• Project management experience.
• Leadership skills to lead cross-functional teams.
• Continuous improvement mindset
• Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.

This position may also include the following conditions:

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.