General Application

AGC Biologics, where your work makes a difference for patients every day. Join a diverse, global team as we create life-changing therapeutic solutions for patients around the world. As industry leaders in the biopharmaceutical space, our growth is only possible thanks to the exceptionally strong partnerships we forge with our employees. By empowering you as a whole person, we create opportunities for you to grow individually and for us all to grow as a team.

 

SUMMARY:

The Supervisor, Manufacturing is responsible for overseeing staff in the execution of production processes for GMP manufacturing operations, monitoring compliance with established processes and standards, and ensuring all safety regulations are strictly adhered. 

 

PRINCIPAL RESPONSIBILITIES:

  • Develop and lead successful manufacturing teams during manufacturing set up and design as well as during routine operations.
  • Lead cross functional teams with Engineering, Project Management, and Process Development.
  • Ensure training of manufacturing staff for critical bioprocess operations, both upstream and downstream.  
  • Identify and drive process optimization solutions.
  • Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.
  • Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.
  • Responsible for the daily organization of workflow; delegate responsibilities for shift operations as needed.
  • Responsible for completing the required documentation including, but not limited to, deviation reports, change control, product change over and maintenance task.
  • Responsible for the review and approval of executed manufacturing MBRs.
  • Monitor staff during operations as described in standard operating procedures and batch records.
  • Ensure staff complies with all company/regulatory quality systems, safety procedures, and SOPs.
  • Review and ensure errors during manufacturing operations are corrected.
  • Establish priorities, set clear expectations, and demonstrate high standards of work practices.
  • Promote a safe work environment.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Knowledge of Aseptic Techniques and adherence to cGMP practices
  • Must be able to communicate clearly, both verbal and written, in English
  • Demonstrated expertise using Microsoft Excel and Word; Technical writing skills preferred
  • Strong organization skills with the ability to prioritize tasks for staff
  • Ability to work hours necessary to support production and/or maintenance activities
  • Ability to lift up to 40 lbs. with assistance
  • Ability to work in confined spaces and near operating equipment
  • Ability to work in loud noise environments

 

EDUCATION/EXPERIENCE:

  • 5+ years GMP operations experience, including 3+ years leading a team/group
  • BS in Biochemistry, Biology, Chemistry or related field desired
  • Equivalent education and experience may substitute for stated requirements
  • Experience in one or more of the following Bioprocess operations (filtration, purification, cell culture or recovery) a plus

 

We are AGC Biologics, a leading global Contract Development and Manufacturing Organization with a deep commitment to improving life quality through biopharmaceuticals. Join us in our pledge to deliver a reliable and compliant drug substance supply, Right. On time. We offer a competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. For more information, visit www.agcbio.com.

 

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 www.dol.gov/ofccp.

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 www.dol.gov/ofccp.

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.