Process Engineer III, Downstream MSAT

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Job description

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.

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Position Summary:

The Process Engineer III role in Manufacturing Sciences and Technology Team (MSAT) is experienced with multiple biologic drug substance / product manufacturing platforms.Downstream manufacturing processing support and Team leader for cross-functional tech transfer and process validation teams (including members from multiple sites) responsible for coordination, execution, and tracking program progress. The position is responsible for both early and late-stage technology transfers. The Process Engineer III is responsible for leading the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing. This position will work cross-functionally to define and support the manufacturing processes for current Good Manufacturing Practice (cGMP) production.

Position Responsibilities:

• Serve as a Downstream (clarification, chromatography, TFF, sterile fill/finish) technical lead for the vector manufacturing process in MSAT Team.

• Provides technical guidance and leadership during on-floor operations and deviation investigations.

• Technology Transfer Technical Leader for cross functional team

• Drives the introduction of new manufacturing processes for clinical and commercial manufacturing of viral vectors.

• Leads the knowledge transfer and gap assessment of new processes.

• Support technical documentation drafting and review with a strong understanding of process control strategies, manufacturing equipment, in-process testing, etc.

• Provides guidance and leads facility fit assessments of manufacturing processes in production suites using FMEA or similar risk-based approaches

• Author and execute tech transfer plans, technical protocols and reports, risk assessments, change controls, and process validation plans/protocols.

• May support other tasks as determined by management.

Minimum Qualifications:

• Strong leadership, relationship management, and organizational planning.

• Ability and willingness to learn and adapt skillsets for various areas of MSAT.

• Knowledge of cGMP compliance around bioprocess drug substance manufacturing.

• Strong technical expertise in downstream operations (clarification, chromatography, ultrafiltration/diafiltration, etc.) and single-use technologies.

• Knowledge of regulatory compliance in pharmaceutical development.

• Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint).

• Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.

Preferred Qualifications:

• BS/MS in Engineering or a related field or Biological Science or related field with 6-8 years of experience in a technical engineering role or related areas (or a combination of education and experience)

• Experience in implementing special project(s) related to operational process improvement.

• Experience in purification process development is a plus.

• Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections is a plus.

• Prior cGMP cell or gene therapy manufacturing experience is highly desired.

• Experience using MS Project and statistical software (such as JMP).

Other Ideal Personal Characteristics:

• Ability to work in a matrixed-team environment and balance work for multiple projects.

• High proficiency for problem solving in teams and as an individual contributor.

• Good verbal and technical writing skills

• Independently motivated, detail oriented and good problem-solving ability.

• Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.

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 $85,000.00 - $126,250.00 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.

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