Scientist I, Downstream Process Development, Nucleic Acids

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

We are seeking a highly skilled and experienced Scientist I in Downstream Process Development to join our dynamic and innovative team.As a Scientist on this team, you will work collaboratively with colleagues throughout the Resilience network to develop and transfer robust therapeutic downstream bioprocesses for Resilience's Nucleic Acids partners and drive development and implementation of innovative internal technology platforms for biomanufacturing.

Job Responsibilities

Project support:

• Lead or contribute to both internal and external client projects as a downstream SME.

• Support downstream activities including: design and optimization of downstream processes, process characterization, scale-up and technology transfer, and documentation and reporting.

Design and Optimization:

• Lead the design, development, and optimization of downstream purification processes for the recovery and purification of biopharmaceutical products.

• Utilize your expertise in chromatography, filtration, centrifugation, and other relevant techniques to develop efficient and high-yield purification strategies.

• Work collaboratively with cross-functional teams to ensure seamless integration of downstream processes with upstream process and analytical development activities.

Process Characterization:

• Conduct process characterization studies to evaluate critical process parameters, process robustness, and process performance using statistical analysis tools and Design of Experiments (DoE) methodologies.

• Generate, analyze, and interpret data to drive process improvements and enhance process understanding.

• Ensure compliance with regulatory requirements and industry best practices during process characterization and validation activities.

Scale-up and Technology Transfer:

• Collaborate with manufacturing teams to facilitate the transfer of downstream processes from laboratory-scale to pilot-scale and ultimately to full-scale manufacturing.

• Participate in technology transfer activities, ensuring successful implementation of processes at Resilience manufacturing sites.

• Provide technical support and troubleshooting expertise during process scale-up and manufacturing operations.

Documentation and Reporting:

• Prepare and maintain accurate and detailed experimental records, technical reports, protocols, and standard operating procedures (SOPs) according to Good Documentation Practices (GDP).

• Communicate research findings, project updates, and process recommendations to internal stakeholders through written reports, presentations, and team meetings.

• Contribute to the preparation and review of regulatory submissions, including INDs, BLAs, and other relevant documents.

Assist with organizing and streamlining work activities, including:

• Ensuring adequate and appropriate inventory of materials and supplies.

• Ensuring equipment is appropriately maintained and calibrated.

• Interacting with suppliers on design, procurement and testing of PD equipment

Leadership and Mentorship:

• Act as a technical SME within the downstream process development team, providing guidance, mentorship, and training to junior scientists.

• Foster a collaborative and innovative work environment, encouraging the exchange of ideas and knowledge sharing.

Required Qualifications

• Relevant expertise in chromatography techniques (e.g., affinity, ion-exchange, size exclusion), filtration (e.g., ultrafiltration, diafiltration), and other purification methods in an academic or industry development setting.

• Excellent problem-solving skills and the ability to troubleshoot process-related issues.

• Strong analytical and data interpretation skills, with proficiency in data analysis software and statistical analysis tools.

• Excellent communication skills, both written and verbal, with the ability to present complex technical information to diverse audiences.

• Demonstrated leadership abilities and a track record of effectively collaborating within cross-functional teams.

Preferred Qualifications

• Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related field

• 1-3 years of biotech industry experience

• Extensive hands-on experience in downstream process development within the biotech or pharmaceutical industry.

• Experience with high throughput technologies such as Tecan

• Experience with technology transfer and scale-up of downstream processes to commercial manufacturing.

• Familiarity with regulatory guidelines and requirements for biopharmaceutical process development and manufacturing (e.g., cGMP, ICH guidelines).

• Proficiency in process characterization using statistical analysis tools and DoE methodologies.

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 annualized base pay hiring range for this position is $90,000.00 - $116,250.00. 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.