Scientist II, Formulation

About the role

A Scientist II in Protein Purification will join a team performing all tasks related to protein purification in a controlled manufacturing laboratory environment. This role involves using protein purification equipment and analytical techniques to execute manufacturing processes, evaluate performance, troubleshoot issues, and support continuous improvement.

Responsibilities

• Purify protein products in a laboratory setting following standard operating procedures and controlled manufacturing documentation.
• Utilize laboratory techniques, calculations, materials measurement, equipment operation, and accurate record-keeping.
• Perform column purification/chromatography, tangential flow filtration (TFF), buffer preparation, SDS-PAGE analysis, and other protein characterization techniques.
• Operate Cytiva ÄKTA FPLC systems using UNICORN software and Bio-Rad NGC chromatography systems.
• Apply technical knowledge of protein purification and chromatography to analyze process data, evaluate chromatograms, and ensure processes operate within established parameters.
• Identify and troubleshoot routine process and equipment issues; escalate complex or unexpected technical issues and support troubleshooting activities.
• Maintain accurate Batch Data Records, work orders, equipment records, and other required documentation.
• Maintain equipment, materials, product inventories, and related records.
• Support the authoring and revision of technical documents, including standard operating procedures and manufacturing batch records, within the Quality Management System requirements.
• Participate in process improvement activities to enhance product quality, yield, process robustness, and productivity.
• Support validation, qualification, investigations, and implementation of new or revised manufacturing processes.
• Collaborate effectively with team members and cross-functional partners to support production, quality, and technical objectives.
• Comply with company safety procedures, Quality Management System requirements, and EH&S programs; maintain knowledge of Safety Data Sheets (SDSs) for relevant materials.
• Perform other related duties as required or assigned.

Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, or a related discipline, or an equivalent combination of education and relevant experience.
• 3+ years of relevant experience in protein purification within a manufacturing environment or R&D laboratory.
• Hands-on experience with Cytiva ÄKTA FPLC systems and UNICORN software and/or Bio-Rad NGC chromatography systems.
• Experience with multiple chromatography modes, including affinity, ion-exchange, size-exclusion, and/or hydrophobic interaction chromatography, with an understanding of protein/resin interactions.
• Demonstrated ability to execute protein purification processes, analyze results, identify technical issues, and troubleshoot routine problems.
• Experience with tangential flow filtration (TFF) and other downstream protein processing techniques preferred.
• Experience working within a Quality Management System; experience with ISO 9001 and/or GMP environments is preferred.

Skills

• Working theoretical and practical understanding of protein chemistry, chromatography methods, and protein purification techniques.
• Demonstrated scientific troubleshooting and problem-solving skills, with the ability to recognize when additional technical support or escalation is required.
• Ability to execute scientific procedures with limited supervision, analyze results, recognize unexpected outcomes, and communicate findings effectively.
• Results-oriented and data-driven with excellent attention to detail and documentation practices.
• Proactive approach to identifying potential issues and contributing to effective solutions.
• Strong collaborative and communication skills with the ability to work effectively within a multidisciplinary team.
• Ability to manage multiple priorities effectively in a manufacturing environment.
• Intermediate Excel skills.

Working Conditions

• Works in a clean, controlled manufacturing laboratory environment with specialized equipment.
• Regularly required to lift up to 20 pounds; may occasionally lift 45 pounds or more with assistance and/or appropriate equipment.
• May be required to stand for extended periods while performing duties.
• Must be flexible to work varying schedules and hours as needed.
• Must be able to work safely with chemicals and hazardous materials.
• Must be able to work in a +4°C cold room.

Pay

The pay range for this position is $30.00 - $31.00 per hour. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance.
• Critical Illness, Accident, and Hospital insurance.
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents).
• Short- and long-term disability.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation, or Sick Leave).

Schedule

This is a contract position based in Carlsbad, CA, and requires a fully onsite presence. The role may require flexibility in working hours and schedules.