AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit



The Quality Control Scientist I – Biochemistry will perform routine and more complex tasks in the Quality Control laboratory, including testing of in-process, release, and stability samples, execution of method transfer and validation studies, and instrument qualification. The ideal candidate will have extensive experience in a GMP laboratory, strong technical writing skills, and proficiency with HPLC, CE-SDS, ELISA and other biopharmaceutical analytical techniques.



  • Perform in-process, release and stability testing of biopharmaceutical test samples in a GMP QC laboratory using a wide variety of technologies, including HPLC/UPLC, capillary electrophoresis (CE-SDS and icIEF), ELISA, and cell-based bioassays.
  • Execute method transfer and validation studies, develop data processing and report templates, and troubleshoot assays and instruments.
  • Author, review and approve test methods, procedures, specifications, and validation documents.
  • Assist in the onboarding and qualification of new laboratory instruments. Author user requirement specifications, IOQ protocols, data integrity risk assessments, and operation and maintenance
  • Mentor and train analysts on test methods and laboratory procedures, good documentation practices, data review, and other QC quality systems.
  • Lead change controls, investigations, and CAPAs in support of GMP operations. Drive Quality deliverables to closure by agreed upon due dates.
  • Represent QC during client audits and regulatory inspections. Maintain the QC laboratory in an inspection ready state.



  • Extensive experience with biopharmaceutical analytical techniques such as HPLC, CE-SDS, ELISA, bioassay, and/or compendial testing.
  • Experience with GMP laboratory data systems, including LIMS, Empower, SoftMax Pro, or other analytical systems.
  • Knowledge of FDA and ICH requirements for method transfer, validation, data integrity, and compendial verification.
  • Demonstrated ability to work effectively on cross-functional teams, including with Analytical Development, Quality Assurance, Manufacturing, and Validation personnel.
  • Strong organizational and project management skills, including technical writing and presentation of technical data.



  • Education: Minimum BS in Biochemistry, Biology or other scientific discipline  
  • Experience: Minimum of 5+ years in a GMP laboratory environment, preferably in the biopharmaceutical industry.
  • Trained in fundamental GMP quality systems, including good documentation practices, data integrity, change management, and laboratory controls.  
  • Experience with the design, operation, validation, and maintenance of complex laboratory equipment and software systems.



$87,417 - $104,900 annually


AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Apply for this Job

* Required

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in AGC Biologics ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.