BioProcess Engineer III, Manufacturing Engineering-MSAT

Pick a challenge that is bigger than your lifetime.

New ideas are all around us, but only a few will change the world. That’s our focus at Nutcracker. We are an early-stage company looking at mRNA and its production in a completely different way. We are challenging the conventional and merging both innovative science with engineering to not just save lives, but to improve the manufacturing and delivery of critical health solutions. Yes, as our name implies, we are working to crack some of the toughest scientific and engineering nuts out there. If you are driven to discover, create, and inspire something that moves science and technology forward, and lasts a lifetime and beyond, you’re ready to be a Nutcracker.

Responsibilities

• Responsible for downstream Therapeutics manufacturing engineering, which includes acidification of mRNA, formulation mixing of mRNA with a lipid delivery vehicle followed by Tangential Flow Filtration, dilution, filtration and Fill and Finish.
• Lead continuous improvement projects (CIP) to streamline and improve process performance, yield, cost and cycle time.
• Lead and assist in the execution of experiments to support process improvement and optimization efforts. This may involve preparing buffers and reagents, setting up equipment, monitoring and collecting data, and maintaining detailed records.
• Lead, facilitate, and assist in risk assessments (pFMEA, FMECA), gap analyses, and other related risk analyses.
• Analyze data using statistical tools and software to identify trends, patterns, and opportunities for process improvements. This may include performing data cleaning and preprocessing, conducting statistical analyses, and developing control charts, process trend charts to help visualizations to communicate results.
• Work with cross-functional teams to ensure successful technology transfer of processes and equipment into manufacturing. This may involve assisting with the design and implementation of scale­ up experiments, troubleshooting process issues, and collaborating with cross-functional teams to address technical challenges.
• Assist in the preparation of technical reports, presentations, and other documentation to support process manufacturing engineering and optimization efforts. This may include summarizing experimental results, developing recommendations for process improvements, and presenting findings to internal and external stakeholders.
• Participate in cross-functional teams to provide technical expertise and support for manufacturing-related issues. This may involve collaborating with Process R&D, Quality(QA,QC), Manufacturing Operations, and other functions to identify and resolve process issues, troubleshoot equipment problems, and ensure compliance with regulatory requirements and company standards.
• Partner with Manufacturing Operations and HW Engineering to investigate equipment and process related issues or failures.
• Use structured problem-solving methodologies to implement containment, correction actions, identify root-cause and develop solutions that can be implemented in manufacturing.
• Drive and support major/critical deviation investigations, CAPAs, and change controls. Lead product impact assessments for deviations.
• Develop, review, and revise manufacturing process descriptions, master batch records, process performance/process validation protocols, equipment qualification protocols, and associated reports.
• Support on-the-floor Manufacturing production activities, as required.
• Collaborate with peers and mentors to share knowledge, best practices, and lessons learned, and actively seek out opportunities to develop new skills and deepen technical expertise.
  
  

Requirements

• Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline preferred.
• 2 years' manufacturing and development operations related experience preferred.
• Applicable experience in aseptic manufacturing environment preferred.
• Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus.
• Knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
• Working knowledge of scientific and engineering principles.
• Ability to function in a fast-paced small company environment with minimal direction and ability to adjust workload based upon changing priorities.
• Ability to think critically with demonstrated trouble shooting and problem-solving skills.
• Excellent interpersonal, verbal and written communication skills.
• Self-motivated and flexible, with the willingness to take on temporary responsibilities as needed to support team or business goals.
• Excellent computer skills, MS Office proficiency.
• Familiarity with statistical analysis and modeling software (e.g., JMP).
• Experience with laboratory techniques and equipment commonly used in biopharmaceutical manufacturing (e.g., pipetting, filtration, sampling, etc.).
• Strong analytical and problem-solving skills, with an ability to think creatively and identify innovative solutions to technical challenges.
• Excellent written and verbal communication skills, with an ability to convey technical information clearly and concisely to both technical and non-technical audiences.
• Ability to work independently and in a team environment, with a willingness to learn and collaborate with others.
  
  

$125,000 - $140,000 a year

The expected range for BioProcess Engineer III, Manufacturing Engineering-MSAT is $125,000 to $140,000 per year based on candidate experience, education, location, and other job-related factors.

Nutcracker Therapeutics is an early-stage life science company building a workplace where highly collaborative and diverse teams thrive. If your best work is performed in a fast-paced entrepreneurial work environment where meaningful work is mastered each day, we’d love to hear from you.

Nutcracker Therapeutics is an equal opportunity employer and values diversity, as such, we do not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), taking or requesting  statutorily protected leave, or any other basis protected by law.

Agency Disclaimer

Nutcracker Therapeutics, Inc. (hereafter, Nutcracker) does not accept unsolicited resumes from recruiters or employment agencies in response to the Nutcracker Careers page or a Nutcracker social media post. Recruiters, agencies and other persons need to have written agreement with Nutcracker, and written approval from a Nutcracker Human Resources representative, to submit resumes for a specific position in order to receive credit. Nutcracker will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes and without a written agreement. Nutcracker explicitly reserves the right to hire said candidate(s) without any financial or other obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Nutcracker.