Research Associate - GMP Purification
Listed on 2026-07-14
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Pharmaceutical
Medical Technologist & Lab Technician, Pharmaceutical Manufacturing, Quality Engineering
Pay Range
$40,300.00 - $66,250.00
Position SummaryThis position is responsible for the purification of proteins and polyclonal/monoclonal antibodies in a GMP laboratory environment while adhering to Good Manufacturing Practice (GMP) guidelines. The role supports the production of GMP, ACFP, natural, and other products utilized by pharmaceutical and IVD customers.
Key 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.
- Monitor 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.
Education and Experience
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- Good understanding of GMP regulations, laboratory documentation practices, and controlled environments.
- Knowledge of protein and antibody purification methods and chromatography principles.
- Familiarity with laboratory safety procedures and chemical handling requirements.
- Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
- Strong laboratory technique skills with precision and attention to detail.
- Experience in technical documentation, recordkeeping, and data management.
- Strong planning, organization, time management, and multitasking abilities.
- Capacity to build effective working relationships and collaborate across teams.
- Excellent written and verbal communication, including technical writing.
- Ability to follow detailed procedures and maintain compliance with GMP standards.
- Ability to work independently while managing multiple priorities.
- Discretion in handling confidential and proprietary information.
- Adaptability to changing business and production priorities.
- High level of accuracy in a regulated laboratory environment.
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 RequirementsAbility 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 and Why Join Bio-TechneWe offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and d. We invest in our employees’ financial futures through 401(k) plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. We empower our employees’ careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We…
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