Research and Development Lab Technician Process Development

Schedule: Monday to Friday 7:30 am to 4:00 pm

JOB SUMMARY

The Process Development Specialist will set up, operate, and maintain laboratory instruments and equipment, make observations, and calculate and record results. The role will participate in the scale-up and manufacture of biological materials and will handle a variety of biological and chemical substances, including human and animal blood, organic and inorganic solvents, and related materials, in compliance with written procedures, and ISO and OSHA requirements. The Process Development Specialist will work and participate in a team environment where shared responsibilities, problem solving, achieving team goals, and continuous improvement of the production process are basic expectations.

ESSENTIAL DUTIES, FUNCTIONS, AND RESPONSIBILITIES

• Aid in production duties including but not limited to, serum depletion, sterile filtration, protein and antibody purification.


• Prepare serum samples from the antibody program – this may include resin conjugation, functional testing, antibody purification, and final packing per customer specifications. It may also include coordination with the team at the Gentry farm to retrieve serum or drop off supplies.


• Perform standard bioprocessing methods to produce biological materials using classical and advanced chromatographic methods.


• Perform contract research work for customers. This may include fermentation projects, antibody projects, formulation changes, etc. for new and existing products.


• Perform process optimization and development studies on existing and new manufacturing procedures to increase yields, decrease costs, increase efficiencies, etc.


• Collaborate with supply chain/sourcing to identify appropriate vendors for supply of raw materials, reagents, etc that supports process development and manufacturing.


• Conduct standard biological, microbiological, or biochemical tests and laboratory analyses (electrophoresis, protein analysis, etc.) and a variety of immunoassays (ELISA, complement assays, etc.) to evaluate the quantity or quality of chemical and biological materials for qualification or release.


• Utilize the ERP system for inventory allocation across all products in bioproduction.


• Comply with all relevant regulatory requirements and internal policies and procedures in completing development of manufacturing activities.


• Exhibit exemplary attendance and punctuality.


• Perform other duties as assigned.

EDUCATION & RELATED EXPERIENCE

• A bachelor's degree in biology, chemistry, biochemistry, biotechnology, bioengineering, or a similar field is preferred with 5+ years of laboratory experience.


• Previous experience in biochemical purification and analytical chemistry preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Knowledge and understanding of safety procedures and industry regulations and guidelines required by the Occupational Safety and Health Administration (OSHA), United States Department of Agriculture (USDA), and Food Safety and Inspection Service (FSIS).


• A familiarity with ISO 9001 standards and biological production.


• Proficiency with Microsoft Office Suite and Google Docs.


• Initiative to take on responsibilities, work independently and make valuable work contributions to the team.


• The ability to analyze information and use logic to address research and manufacturing questions and other work-related issues and problems.


• The ability to understand and comply with all company policies and procedures, and all applicable state and federal laws.

SUPERVISORY RESPONSIBILITIES AND INTERACTIONS WITH OTHERS

The Process Development Specialist has no supervisory responsibilities. However, the role will be expected to frequently interact with co-workers and management.

WORKING CONDITIONS

Work is performed in an indoor environment, but exposure to fluctuations in temperature may be required, including exposure to cold temperatures (-20°C and below) for short periods of time. Work will be conducted in areas where biological products are collected and tested, and the position may face exposure to human/animal blood, inorganic solvents, and other related materials. Work is conducted in the ISO classified areas where standard operating procedures and OSHA requirements must be followed. The noise level in the work environment is usually moderate.

This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. The responsibilities, tasks, and duties may differ from those outlined in the job description and other duties, as assigned, may be required. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, disability, veteran status, genetic information, or any other status protected under applicable local, state, or federal nondiscrimination laws.

This document does not create an employment contract. Employees are employed on an "at-will" basis and may be terminated at any time. Consistent with all federal and state disability laws, Pel-Freez will provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause a direct threat to this individual or others in the workplace and the threat cannot be eliminated by reasonable accommodation or cause undue hardship to the organization Pel-Freez provides equal employment opportunities to all applicants.