Biochemist II - GMP Recombinant Protein Manufacturing

BioLegend, Inc.; San Diego (CA); On-site; USD 42,000 - 62,000; Full time

Job summary

BioLegend, Inc. in San Diego is seeking a GMP recombinant protein Biochemist to purify, conjugate, and formulate recombinant proteins for GMP product release.

You will support manufacturing, collaborate with QA/QC, and help manage raw materials, inventory, and batch records in a cross-functional team. The role involves purification using IMAC, size exclusion, ion exchange, and AKTA FPLC, with a focus on compliance and documentation within ISO 9001:2008/13485 environments.

Qualifications

• BS in Life Science or related field required.
• 2+ years experience in biotech protein/antibody manufacturing.
• Experience in purification and formulation of recombinant proteins/antibodies.
• Experience in ISO/GMP manufacturing environment.
• Detail-oriented, organized, and able to work in small teams.
• Proficient with MS Office and Outlook.

Responsibilities

• Purify recombinant proteins using chromatography and purification methods (e.g., IMAC, size exclusion, ion exchange).
• Conjugate and formulate proteins following SOPs under ISO/GMP guidelines.
• Support GMP product release and quality control processes.
• Assist cross-functional manufacturing tasks and document control.
• Maintain QA compliance and traceability; support CAPA systems.

Skills

Protein purification

GMP/ISO compliance

Quality control

Documentation & record-keeping

Attention to detail

Team collaboration

Education

Bachelor of Science in Life Science or related area

Tools

MS Office

Job description

BioLegend | About Us

At BioLegend, we are committed to providing researchers with the most comprehensive and cutting-edge high-quality reagents for life science research. Being part of Revvity, a global provider of health science solutions, technologies, expertise and services for life sciences and diagnostics, allows us to extend the mission of enabling our customers to do legendary discovery. Join us and make a difference!

Job Summary

This GMP recombinant protein Biochemist at BioLegend will primarily be responsiblefor performingprotein purification,conjugation,formulation, and quality control for GMP product release. This position will assistinGMP proteinmanufacturingforGMP products. The position plays an important part in the success of the robust GMP recombinant protein productmanufacturingand will actively support team members in managingraw material, inventory,and batchrecordsthrough efforts collaborating with other departments such as manufacturing, quality assurance, and quality control teams.

The Biochemist will perform purifying recombinant proteins using various preparative chromatography methods and separationusing methodssuch as IMAC, size exclusion, and ion exchange, conjugationand formulate the recombinant proteins according to standard operating procedurescompliant with ISO and GMP regulation.

This position will also support a variety of cross-function manufacturing tasks including work order processing and closure ofpilot lotsrelated to product release or validation.

His/her role also assists in activities for technical support, document control, validation, training, nonconformance, and CAPA systems.

Essential Functions

• Following standard procedures to conductrecombinant protein or antibody purificationusingaffinity matrix such asIMAC and Protein A Sepharose.
• Following standard procedures to conduct proteinconjugation and polishing using varioustypesofchromatography andAKTA FPLC.
• Conduct the in-processquality testingsuch as purity analysis, endotoxintestingforthein-house made or customizedbulkmaterialof finished goods.
• Support internalsafety and regulatory compliance audits
• Supportequipmentoperationtrainingand validation activities fornew process and equipment validation
• Providebenchworksupportforproduct releasing or troubleshooting of complicated manufacturing problems in recombinant protein production to ensure sustainable manufacturing design
• Support reviewingof quality system documentsand corrective actions(NCR, or CAR)to ensure laboratory setting and proceduresarein compliance withISO9001:2008/ 13485:2016
• Proactively identify opportunities to improve current manufacturing proceduresin order toincrease efficiency and consistency to ensure QA compliance in traceability and equivalency.
• Other projects or responsibilities may be required.

Minimum Qualifications–Education And Experience

• Bachelor of Science in Life Science or related area.

Preferred Qualifications – Education And Experience

• Bachler's Degree in Life Science or related area with at least2yearsof working experience in related biotech protein or antibody product manufacturing.
• Extensive experience inprotein or antibody purification.
• Experienced in purification and formulation of recombinant protein or antibody.
• Experienced inmanufacturing under ISO/GMP environment.
• Demonstrated ability to be detail-oriented, organized and work well in small work groups
• Able to perform basic computer operations such as MS Office and Outlook and other computer-based software

Work Environment & Physical Demands

Lab

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

The base salary range for this full-time position is $20.00 - 30.00/hr. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our page. Log-In instructions are provided towards the bottom of the Bswift page.

For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.