Biochemist I – GMP

BioLegend, Inc.; San Diego (CA); On-site; USD 28,000 - 37,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Life and Disability Insurance

Paid Time-Off

Parental Benefits

Comprehensive Care Leave

401k with Company Match

Employee Stock Purchase Plan

Job summary

BioLegend, Inc. is seeking a Biochemist I – GMP to support manufacturing of regulated products in our US FDA registered cGMP facility in San Diego.

You will formulate and vial products, maintain batch records, inspect buffers, and prepare materials for lyophilization, ensuring compliance with GDP and ISO13485. The role requires a bachelor’s degree and 1 year biotech experience, strong attention to detail, and teamwork in a fast-paced environment.

Qualifications

• Bachelor’s degree with 1-year biotechnology industry experience.
• 1 year of working experience with Good Documentation Practices (GDP)

Responsibilities

• Prepare various buffers for manufacturing activities.
• Perform incoming inspection of raw materials.
• Perform formulation and vialing of regulated products, which includes filling, capping, and labeling.
• Assist in troubleshooting the manufacturing process.
• Maintain batch records and other documentations in compliance with ISO13485:2016 and cGMP.
• Maintain/troubleshoot laboratory equipment and manage supplies.
• Perform data entry tasks, including processing production orders.
• Work as a team to advance multiple projects simultaneously
• Other projects or responsibilities may be required.

Skills

Attention to detail

Communication skills

Teamwork

Documentation practices

Education

Bachelor’s degree in biology/biochemistry/chemistry or related areas

1 year biotechnology industry experience

GDP knowledge/experience

Job description

Job Summary

The Biochemist I – GMP position will be responsible for the different stages of manufacturing various BioLegend’s regulated product produced in our US FDA registered cGMP manufacturing facility.

This rolewill be responsible for formulating and vialing, completing batch records, putting away finished good inventory (FGI), data entry, equipment maintenance and supply inspections & storage. Other responsibilities include buffer preparation and inspection of incoming buffers into the GMP suite, as well as material preparation for Lyophilization and post lyophilization processes.

This role will prepare product/project related documentation and maintain the device history records for all the regulated products and will work closely with product development on new products in order to establish a smooth transition into manufacturing.

The Biochemist I – GMP will work independently and as a team player. The ideal candidate will be organized and detail oriented, have strong communication skills, and is able to work in a very fast paced environment.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prepare various buffers for manufacturing activities.
• Perform incoming inspection of raw materials.
• Perform formulation and vialing of regulated products, which includes filling, capping, and labeling.
• Assist in troubleshooting the manufacturing process.
• Maintain batch records and other documentations in compliance with ISO13485:2016 and cGMP.
• Maintain/troubleshoot laboratory equipment and manage supplies.
• Perform data entry tasks, including processing production orders.
• Work as a team to advance multiple projects simultaneously
• Other projects or responsibilities may be required.

Minimum Qualifications – Education and Experience

• Bachelor’s degree with 1-year biotechnology industry experience.
• 1 year of working experience with Good Documentation Practices (GDP)

Preferred Qualifications – Education and Experience

• Bachelor’s degree in biology, biochemistry, chemistry, or other related areas
• Working experience in the Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.

• 1 year of experience in a laboratory and/or biotech manufacturing environment, performing filling, bottling, and packaging.

• Advanced pipetting skill is highly preferred.
• Familiarity with raw material supply receiving and inspection processes.
• Excellent verbal and written communication skills
• Demonstrated knowledge of aseptic techniques in biosafety cabinet
• Demonstrated ability to work well in small groups and adhere to timelines.
• Excellent attention to detail and organizational skills

Applicants must be currently authorized to work in the United States on a full-time basis for any employer.

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.

Compensation

The base salary range for this full-time position is $20.50 - 27.00/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
• Comprehensive Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Bswift 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.