Lead BioProcess Associate

Emergent BioSolutions, Inc.; Canton (MA); On-site; USD 84,000 - 102,000; Full time

Job summary

Emergent BioSolutions, Inc. in the United States is seeking a Lead Bioprocess Associate to lead a manufacturing team focused on bulk vaccine production, ensuring production goals and schedule adherence within GMP standards.

The role covers Upstream, Downstream, or Final Formulation as needed, with responsibility for coaching junior staff, maintaining cleanroom discipline, and supporting audits and change controls.

Qualifications

• Bachelor's degree in a Scientific, Engineering or Biotech field with 6+ years' GMP biologic production experience.
• Strong knowledge of GMP standards and documentation practices.
• Excellent documentation skills including review/execution of Batch Production Records and SOPs.

Responsibilities

• Operates manufacturing equipment (autoclaves, washers, bioreactors, TFF skids) in aseptic, GMP-compliant conditions.
• Coach and mentor junior staff; act as SME and trainer for equipment and processes.
• Lead the team to ensure cleanroom discipline, audit readiness, and compliant documentation.

Skills

GMP manufacturing

Biologic production

Documentation skills

Education

Bachelor's degree in Science/Engineering/Biotech

Tools

Autoclaves

Bioreactors

TFF skids

Job description

Preparedness today, safer tomorrow.Emergent is a leading public health company that delivers protective and life-saving solutions to

Preparedness today, safer tomorrow.Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job SummaryThe Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. The Lead Bioprocess Associate is primarily a leadership role in the context of the production of bulk vaccines to meet the production schedule and goals of the site. This role is responsible for supporting the overall GMP manufacturing process that may include Central Services, Upstream, Downstream, or Final Formulation. Responsible leading the team to ensure operations are performed in a safe and compliant manner while ensuring production goals are met.

Essential Functions

• Operates pharmaceutical manufacturing equipment such as autoclaves, parts washers, filter integrity testers, incubators, stainless-steel bioreactors, TFF skids, and in process testing equipment. Ability to operate in an aseptic manner within a BioSafety Cabinet.
• Act as the manufacturing SME and qualified trainer for equipment and processes.
• Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
• Ensure the team in work area is properly gowned, SOPs/BPRs are out and being followed, PPE is being used as required.
• Perform and monitor critical processes, execute routine validation protocols. In real time identify process anomalies or unexpected results and report to management.
• Identify and troubleshoot complex events on equipment and systems used in Manufacturing.
• Own document revisions and assist in the execution and implementation of change controls.
• Executes logbooks, forms, solution prep and batch records according to GMP and site quality standards. Coach and mentor more junior staff to ensure compliant execution of quality documentation.
• Perform real time review of BPRs, forms and logbooks.
• Review logbooks, forms, solution and batch records according to GMP and site quality standards.
• Leads the team to ensure propre cleaning and organization of the manufacturing cleanroom. Ensures the area is audit ready at all times.
• Supports MSat, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment. Supports Emergent QA during audits and regulatory inspections.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Minimum Education, Experience, Skills

• Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
• Bachelor's degree in a Scientific, Engineering or Biotech field typically with 6+ years' experience with biologic production processes under GMP compliance or equivalent commensurate experience.
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Excellent documentation skills including comprehension, review & execution of Batch Production Records, SOP's and forms.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $84,000 to $101,700. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

*Eligibility for benefits is governed by the applicable plan documents and policies.

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.