Your next role as a Miracle Maker

TriLink is seeking a talented professional to join our Process Development team as a Staff Process Development Specialist/Engineer. In this role, you will oversee and manage process development initiatives, leveraging your expertise in single-use components, equipment, test design, statistical analysis, and overall process development.

You will be responsible for designing and testing innovative concepts, optimizing existing processes, and ensuring their successful transition into manufacturing-from Discovery to the commercial phase. This includes developing robust and efficient processes that adhere to phase-appropriate regulatory standards, with a specific focus on nucleic acids. Additionally, you will support interdepartmental biomolecule R&D and CDMO projects, ensuring compliance with Good Manufacturing Practices (GMP) throughout all process development activities.

How you will make an impact:

• Oversee process development projects from concept to commercialization, ensuring alignment with timelines and regulatory requirements.
• Develop PPQ protocol and support execution of PPQ including testing, verification, and documentation activities.
• Specification and requirement setting for raw materials, supplies, and equipment.
• Develop and analyze product life cycle with emphasis on risk assessment for materials and process.
• Assist in the launching of new NPIs through development and scale-up.
• Gather and analyze data using statistics, measurement systems analysis, and design of experiments efforts and their associated analysis tools.
• Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.
• Optimize and develop equipment and processes through DOEs, CPPs, and CQAs.
• Mentor and guide junior specialists, fostering a culture of continuous learning and development within the team.
• Follow design, quality, and safety guidelines based on GMP, regulatory, and ISO guidelines and related Quality and Safety Standards and Practices.
• Create detailed process documentation including SOPs and Batch Records, and train staff on new processes.
• Handles complex issues and conducts thorough evaluations to devise methods and procedures for new assignments. Exercises judgment in selecting and adapting techniques, ensuring work aligns with departmental goals.
• Perform other functions and duties as required.

The skills and experience that you will bring:

• A Bachelor of Science in scientific field; preferably Molecular Biology, Biochemistry, Chemical Engineering or equivalent with minimum of 8 years of related experience; or 6 years and a Master's degree; or a PhD with 3 years of experience.
• Extensive experience to develop and resolve complex models and procedures, aligning them with company goals. Offers creative solutions, understands interdisciplinary interactions, and drives policy development.
• Proficient with large scale purification skids and have a strong understanding of UFDF
• Strong understanding of regulatory requirements (FDA, EMA, ISO, etc.) and experience in developing processes compliant with these standards.
• Experience statistical analysis software (e.g., JMP, Minitab) is highly desirable.
• Experience in nucleic acid wet lab techniques including but not limited to the following;
  • Precipitation
  • Column purification
  • Gel/capillary electrophoresis
  • In vitro enzymatic reactions (e.g. restriction digest, PCR, transcription)
• Extra consideration for experience in the following techniques;
  • Cell culture
  • Immunohistochemistry/ELISA
  • Gene editing
  • Bioinformatics
  • Diafiltration
• Self-motivated with ability to multitask, meet project deadlines, and work in fast-paced dynamic environment
• Ability to communicate clearly and precisely, both orally and in writing
• Ability to identify problems and offer effective solutions
• Willingness and ability to manage projects through completion

The anticipated salary range for this position is $132,300 - $147,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.