Sr BioProcess Associate

Emergent BioSolutions, Inc.; Canton (MA); On-site; USD 71,000 - 85,000; Full time

Job summary

Emergent BioSolutions is seeking a Senior Bioprocess Associate to support GMP manufacturing of bulk drug substance and drug product. The role involves operating autoclaves, bioreactors, filtration and testing equipment, while adhering to GMP and aseptic practices.

The candidate should have a scientific/engineering/Biotech background with 4+ years of relevant biologics production experience, strong documentation skills, and the ability to train others as a subject matter expert.

Qualifications

• Bachelor’s degree in a scientific field with 4+ years’ GMP biologics production experience.
• Strong knowledge of GMP principles and aseptic manufacturing.
• Excellent documentation and batch record handling.

Responsibilities

• Operates GMP manufacturing equipment and maintains aseptic conditions.
• Acts as manufacturing SME and trainer for equipment/processes.
• Supports QA during audits and regulatory inspections; maintains records and forms.
• Revises batch records and SOPs as required; ensures audit readiness.

Skills

Strong technical knowledge

GMP experience

Documentation skills

Aseptic technique

Education

Bachelor's degree in a Scientific, Engineering or Biotech field

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 Summary The Senior Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk drug substance and bulk drug product for commercial GMP manufacturing. This role is responsible for supporting the overall GMP manufacturing process that may include Central Services, Upstream, Downstream, or Final Formulation.
Essential Functions

• Operates pharmaceutical manufacturing equipment such as: autoclaves, parts washers, filter integrity testers, incubators, single use and stainless steel bioreactors, centrifuges, disruptors, TFF skids, single-use mixers and in process testing equipment. Ability to operate in an aseptic manner within a BioSafety Cabinet.
• May act as the manufacturing SME and qualified trainer for equipment and processes.
• Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
• Perform and monitor critical processes, execute routine validation protocols.
• Identify and troubleshoot simple unexpected events on equipment and systems used in Manufacturing.
• Executes logbooks, forms, solution prep and batch records according to GMP and site quality standards. Perform department review of logbooks and forms.
• Revises Batch Records, SOPs and forms as required.
• Perform cleaning and organize 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.
• Supports other manufacturing process teams and cross functional partners as necessary to achieve Manufacturing team goals.

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 4+ 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 $70,500 to $85,200. 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.