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 www.agcbio.com.

 

SUMMARY:

Purification Manufacturing Supervisor - Microbial works collaboratively in executing purification bioprocess operations which includes column packing, chromatography TFF, Filling and CIP/SIP operations (cleaning, assembly, sterilization, disassembly, operation of primary process equipment). The ideal candidate possesses strong computer and multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision.

 

PRINCIPAL RESPONSIBILITIES:

  • Ensure staff compliance with all company / regulatory quality systems, safety procedures, and SOPs
  • Review and ensure errors during manufacturing operations are corrected
  • Provide leadership by establishing priorities, clear expectations, and demonstrating high standards of work practices
  • Train, coach and mentor manufacturing technicians / associates on manufacturing functions.
  • Complete required documentation including but not limited to deviation reports, change control, product change over and maintenance task
  • Review/approval executed manufacturing MBRs.
  • Responsible for daily organization of work flow and delegating responsibilities for shift operations as needed
  • Perform and monitor staff during unit operations as described in standard operating procedures and batch records
  • Develop staff (i.e. goal setting, assignment of development activities, performance reviews, etc.)
  • Promote a safe work environment.
  • Unit operations described in standard operating procedures and batch records (50%-100% of effort)
  • Perform manufacturing operations, column packing, chromatography, solution preparation, tangential flow filtration and filling.
  • Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency
  • Complete required processing documentation including deviation reports, change control, product changeover, etc.
  • Identify, create and revise GMP documentation as required including MBRs
  • Review GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
  • Participate in validation activities including IQ/OQ/PQ and process validation
  • Assist in compliance and technical development projects
  • Perform document revisions to Standard Operating Procedures
  • Initial training and application of GMP regulations (ICH Q7A) as it applies to job function
  • Other duties as assigned

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Working knowledge in relevant math, science, and engineering disciplines
  • Ability to communicate, read, and write legibly in English, as well as possession of strong technical writing skills
  • Ability to apply advanced computer skills including work with spreadsheets(Excel) and word processing (Word)
  • Functional understand and experience operating the AKTA chromatography system and unicorn software.
  • Ability to manage time effectively
  • Must be detail oriented with the ability to complete written and verbally assigned tasks following specific procedures
  • Demonstrated ability to apply excellent aseptic technique
  • Working knowledge of GMP regulations (ICH Q7A), as well as experience with equipment and technology as it applies to job function
  • Ability to interact constructively with peers and support groups, using organizational and communication skills necessary to plan and execute work flow

 

EDUCATION/EXPERIENCE:

  • Bachelor’s Degree and 5+ years of relevant work experience, including prior experience in aseptic processing.
  • Proven experience working in manufacturing operations
  • Proven experience and knowledge in bioprocess operations such as solution compounding or tangential flow filtration
  • Equivalent education and experience may substitute for stated requirements

 

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.

 

#LI-DR1

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.