BioProcess Associate

Emergent BioSolutions; Canton (MA); Presencial; USD 58.000 - 70.000; Jornada completa

Descripción de la vacante

Emergent BioSolutions in Canton, MA, seeks a Bioprocess Associate to support GMP manufacturing across upstream, downstream or final formulation. The role requires prior GMP manufacturing experience and the ability to document processes in GMP-compliant logbooks and batch records under supervision.

You will operate equipment such as autoclaves and bioreactors, maintain aseptic conditions, assist in GMP documentation revisions, support QA during audits, and collaborate with cross-functional teams

Formación

• Experience in GMP-compliant biologic production environments.
• Strong documentation capabilities including batch records and SOPs.
• Ability to apply scientific principles to daily manufacturing tasks.

Responsabilidades

• Operates GMP manufacturing equipment and aseptic tools.
• Adheres to GMP standards and safety procedures.
• Documents logbooks, forms, and batch records per GMP.
• May assist in revision of GMP documentation.
• Cleans and organizes manufacturing cleanrooms to stay audit-ready.
• Supports QA during audits and regulatory inspections.
• Collaborates with cross-functional teams to meet manufacturing goals.

Conocimientos

GMP manufacturing experience

Excellent documentation skills

Scientific principles application

Educación

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

Descripción del empleo

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 Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, including operation of GMP process equipment and documenting in a GMP compliant manner. 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, stainless steel bioreactors, centrifuges, TFF skids, and in process testing equipment. Ability to operate in an aseptic manner within a BioSafety Cabinet.
• Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures
• Communicates effectively with team members and supervisors regarding status of daily production tasks.
• Executes documentation for logbooks, forms, solution prep and batch records according to GMP and site quality standards.
• May assist in revision of GMP Documentation.
• Perform cleaning and organization of the manufacturing cleanrooms. Ensures the areas are audit ready at all times.
• 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 2+ 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 & 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 $58,000 to $70,300 . 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.]

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

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.

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.