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:

The MSAT Specialist (Upstream) is part of the team responsible for Process Transfer, Process Validation and Operational Excellence that support GMP cell culture manufacturing operations, Develops new technologies/equipment, and implements new systems, process improvements, equipment and procedures. 

 

PRINCIPAL RESPONSIBILTIES:

  • Participate as MSAT representative on client project teams.
  • Lead activities to transfer processes to Manufacturing from internal AGC Process Development at other sites or directly from customers, including driving the drafting and revising manufacturing batch records.
  • Perform manufacturability assessments for new process introductions.
  • Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
  • Provide technical leadership to Manufacturing and other departments associated with GMP operations.
  • Serve as the process Subject Matter Expert provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations.
  • Participate in the project team meetings, decisions, and creation of milestones representing MSAT.
  • Serve as the key project designee responsible for identifying new technologies set to improve manufacturing capabilities.
  • Maintain and report process run summaries and continued process verification reports.
  • Prepare and present data associated with manufacturing processes to internal and external clients.
  • Support for process validation preparation, execution, and reporting.
  • Maintenance of Process Control Strategy.
  • Work with clients on process mapping and scale-up of manufacturing processes.
  • Other duties as assigned.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Must be self-motivated, organized and proactive.
  • Demonstrated ability to interface/communicate extensively with internal and external clients.
  • Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, QC, etc.).
  • Proven experience successfully managing multiple projects simultaneously.
  • Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
  • Demonstrated experience leading troubleshooting efforts.
  • Ability to provide technical training to others on GMP manufacturing operations.
  • Strong communication skills necessary to interact with internal stakeholders.
  • Strong presentation skills.
  • Expertise in relevant math, science and engineering disciplines.
  • Expertise in Cell Culture from thaw to API fill.
  • Expertise in Disc-Stack centrifugation.
  • Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function.
  • Large scale stainless steel experience will be preferred.

 

EDUCATION/EXPERIENCE:

  • BS in Biochemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred.
  • 3+ years’ relevant experience from the pharmaceutical industry working in a cGMP environment.
  • Advantage with relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness.
  • Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
  • Must have experience writing, reviewing and approving GMP documentation.
  • Advanced computer skills including Excel and Word.

 

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 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.