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 and cell and gene therapies. 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



AGC Biologics is looking for a QA Principal Scientist to provide Quality support for a biologics manufacturing plant startup, implementing robust and compliant processes and systems required for commercial manufacturing operations. The ideal candidate will possess a scientific background to help in the resolution of issues associated to the Manufacturing or any other critical process at AGC Biologics. The Principal Scientist will take a leadership role in solving extremely complex problems, such as critical Deviations and Change Records, which involve cross-functional teams outside of the QA department and clients. They will act as the point of contact for critical investigations, ensuring all reports performed are scientifically sound and well written. They will provide guidance to others in the documentation and submission of investigations for approval.



  • Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with critical deviations.
  • Exercises independent judgment in interpreting and applying regulations to GMP systems. May make recommendations for QA policies and procedures. Interprets complex regulations and guidelines critical for advancing and improving the QA systems.
  • Leads efforts to identify and implement processes and procedure optimization to facilitate compliance.
  • Directly involved in the execution and closure of investigations and the implementation of the associated Corrective Actions/Preventive Actions (CAPAs).
  • Takes a leadership role in planning and implementation of long range Quality goals as they relate to the corporate goals.
  • Has signature authorization for multiple Quality Systems.
  • Accountable for decisions and results that promote the efficiency of the processes at ACG and increase the customer satisfaction level with the internal and external clients.
  • May lead projects or represent QA interests in multidisciplinary project teams. Works closely with other team members in a cooperative fashion to ensure project progression.  May act as an advisor to multiple project teams.
  • Supports and provides leadership to the direction and decisions of AGC Biologics project/transfer teams.
  • Responsible for making recommendations and decisions in accordance with federal and international regulatory requirements and industry standards.
  • Ideally, but not strictly required, the candidate should possess scientific background and expertise in areas such as Quality Control (i.e. testing profiles and Laboratory Investigations) and be familiarized with the Manufacturing and Development processes.
  • The candidate should be familiar with the Operational Excellence tools (i.e. Kaizen, Value Stream Mapping, etc.), basic Risk Management techniques and their applicability in the pharmaceutical industry.



  • Strong technical and analytical understanding of Biologics Manufacturing and testing.
  • Ability to articulate compliance strategy and rationale via oral and written communication techniques. Good organizational skills. Demonstrates leadership in areas of teamwork, conflict resolution, and problem-solving.
  • Expert knowledge of regulatory principles and concepts as they relate to Operations and GMP.
  • Expert knowledge of GMP and regulatory submission requirements.
  • Knowledge in Operational Excellence and Risk Management.



  • BA, BS, or advanced degree in Life Sciences or Engineering with at least 15 years QA-related experience or equivalent work experience.
  • Experience with interpretation and application of regulatory principles, which drive QA strategy.


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

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at AGC Biologics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

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.

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 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.