Sr. Process Engineer

AskBio Inc.; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

AskBio is seeking a Sr. Process Engineer, Manufacturing Science and Technology (MSAT) to support scale-up, technology transfer, and cGMP manufacturing for clinical and commercial programs.

The role involves onboarding clinical programs into the MSAT lab, conducting scale-up runs, and transferring programs to a contract manufacturing facility. Collaboration with internal and external teams is essential to ensure PPQ readiness.

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline with relevance to biopharmaceutical manufacturing.
• Experience in a biopharmaceutical manufacturing environment and a strong understanding of process development.
• Excellent written and verbal communication skills and ability to interact with internal and external stakeholders.
• Proficiency with Microsoft Office Suite and data analysis tools.

Responsibilities

• Collaborate with cross-functional teams to transfer small-scale gene therapy processes into MSAT and scale up to cGMP manufacturing.
• Design, execute, analyze and interpret process characterization experiments to define PPQ strategies.
• Develop predictive small-scale models for scale-up.
• Author protocols and reports and maintain organized electronic lab records.
• Communicate results effectively in technical presentations with stakeholders.
• Lead investigations with data-driven root-cause analysis to resolve issues.
• Maintain a clean, organized laboratory and manage scheduling and materials.

Tools

JMP software

DOE design of experiments

Job description

Opportunity for Secondment to AskBio

We’re pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. If you’re interested in exploring this opportunity, we encourage you to: Speak with your direct manager to discuss your interest and alignment with your development goals.

Our vision

Pioneering science to create transformative molecular medicines.

Our mission

Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles

Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential.

Our values

Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary

AskBio is seeking a Sr. Process Engineer, Manufacturing Science and Technology (MSAT) to join our Process Engineering team and support current and future commercialization efforts. This position supports scale-up, technology transfer of AskBio’s portfolio of gene therapy products into cGMP manufacturing for clinical production, process validation and commercial launch. The incumbent will onboard clinical programs into the MSAT laboratory, perform scale-up runs, and transfer programs to AskBio’s contract manufacturing facility. Additionally, this position will be responsible for performing Phase III clinical enabling activities including scale-down model development, process characterization, and process control strategy definition to enable process performance qualification (PPQ) readiness for both drug substance and drug product manufacturing campaigns. This position is highly collaborative and will require internal and external team interactions to ensure successful process scale-up, technology transfers, and cGMP manufacturing operations to ensure continuity of supply while adhering to global regulations and standards. This role is based on-site at our RTP (Research Triangle Park) Headquarters in NC and reports to an Associate Director, MSAT.

Job Responsibilities

• Collaborate with cross-functional teams to transfer small-scale gene therapy processes from Process Development into the MSAT laboratory and subsequently perform scale-up and transfer to the cGMP manufacturing scale
• Design, execute, analyze and interpret process characterization experiments to generate robustness data and define the process control strategy for PPQ manufacturing campaigns.
• Develop small-scale models that are predictive of the cGMP manufacturing scale
• Author technical protocols and reports to support experimental work and maintain clear, organized electronic laboratory notebooks
• Provide effective communication of experimental results in technical presentations with internal and external stakeholders
• Lead cross-functional investigations by contributing technical expertise to the root-cause analysis and using a data-driven approach for driving issue resolution
• Ensure the laboratory is clean, organized and maintained in an efficient working order, securing supplies and materials for experiments, and proper scheduling of laboratory work

Minimum Requirements

• Bachelor’s Degree in a scientific discipline with 5+ years of relevant work experience in the biopharmaceutical industry OR Master’s Degree in a scientific discipline with 3+ years of relevant work experience in the biopharmaceutical industry
• Hands-on upstream and/or downstream biomanufacturing laboratory experience
• Excellent written and verbal communication skills, with experience interacting with a range of internal and external stakeholder groups
• Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint)
• Highly motivated, organized, and disciplined, with a strong desire to contribute as part of a best‑in‑class, collaborative tech transfer team
• Adaptable and eager to learn, thriving in a fast‑paced, highly interactive environment
• Genuinely interested in building proficiency in upstream and downstream biomanufacturing operations, including process scale‑up, technology transfer, process characterization, and process control strategy development
• Continuous improvement‑oriented, seeking opportunities to optimize process operations and performance through proactive problem solving
• Open to domestic and international travel up to approximately 10%, as needed.

Preferred Education, Experience and Skills

• Prior upstream experience
• Prior experience supporting cGMP manufacturing operations, process characterization, and/or PPQ activities
• Knowledge of the Design of experiment (DOE) methodology with an ability to design, execute, and analyze experiments with minimal oversight.
• JMP Statistical Software proficiency is highly preferred undefined

Equal Opportunity Employer

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‑related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening.