Sr BioProcess Associate

Emergent Biosolutions•Canton, MA

1d•$70,500 - $85,200•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.