Research Associate - GMP Purification

Responsibilities

• Purify proteins and polyclonal/monoclonal antibodies using column chromatography and associated purification techniques.
• Perform filtration, aliquoting, and bottling of products using aseptic laboratory practices.
• Complete batch records and manufacturing documentation in accordance with GMP requirements.
• Assist with GMP bottling and production activities as needed.
• Clean and validate laboratory equipment and procedures to maintain audit readiness.
• Support internal and external audits by ensuring laboratory compliance and organization.
• Revise specifications, standard operating procedures (SOPs), and controlled documents; submit revisions for management review and approval.
• Maintain inventory levels of chemicals, raw materials, consumables, and stock buffers; initiate replenishment requests as needed.
• Ensure equipment calibrations and laboratory maintenance activities remain current.
• Utilize Microsoft Office applications, including Word, Excel, and Outlook, to support documentation and communication needs.
• Maintain confidentiality of sensitive, proprietary, and regulated information.
• Follow all company policies, safety procedures, AWAIR requirements, Chemical Hygiene guidelines, and Exposure Control procedures.
• Perform additional duties and projects assigned.

Qualifications

• Requires a bachelor’s degree in Biochemistry, Biotechnology, Biology, Chemistry, or a related scientific discipline and 0–2 years of relevant laboratory experience.
• Experience with chromatography techniques is preferred.

Knowledge, Skills, And Abilities

• GMP regulations, laboratory documentation practices, and controlled environments.
• Protein and antibody purification methods and chromatography principles.
• Laboratory safety procedures and chemical handling requirements.
• Microsoft Office applications, including Word, Excel, and Outlook.
• Performing laboratory procedures with precision and attention to detail.
• Technical documentation, recordkeeping, and data management.
• Planning, organization, time management, and multitasking.
• Building effective working relationships and collaborating across teams.
• Written and verbal communication, including technical writing.
• Following detailed procedures and maintaining compliance with GMP standards.
• Handling confidential and proprietary information with discretion.
• Adapting to changing business and production priorities.
• Maintaining a high level of accuracy in a regulated laboratory environment.

Working Conditions

• Work is performed primarily in a GMP laboratory and production environment.
• Frequent use of laboratory equipment, chemicals, buffers, and purification systems.
• Use of personal protective equipment (PPE) is required.
• Minimal or no travel required.

Physical Requirements

• Ability to lift and handle materials weighing 5–50 lbs.
• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Manual dexterity required to operate laboratory equipment and perform precise laboratory techniques.
• Ability to move materials and equipment throughout the laboratory and production areas.

Benefits

• Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• Investment in employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Empowerment of employees to develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• Employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• An accrued leave policy with paid holidays, paid time off, and paid parental leave.
• A culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.