Associate BioProcess Specialist

Location
Baltimore (Bayview), MD
Posted
Jan 22, 2022
Ref
836230000
Hotbed
BioCapital
Required Education
Associate Degree
Position Type
Full time


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary 

 

Emergent BioSolutions is currently seeking a BioProcess Associate for our Manufacturing Operations Department for our Winnipeg site. The successful candidate will have a university degree from a recognized university or an equivalent level of education, experience and skills.  The ideal candidate will have 3 years of related work experience, demonstrated ability to collaborate and negotiate solutions in a fast-paced matrix environment and work on complex problems where analysis of situation or data requires an in-depth evaluation of various factors.

 

In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

II: Essential Functions

  • Provides support to the Production organization (including manufacturing, filling and packaging) to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met.
  • Monitors process performance and interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
  • Main objectives are:
  • Ensure harmonized process performance and product quality
  • Harmonize technical support for production sites and manufacturing processes within the network
  • Champion, promote and coordinate manufacturing innovation and sharing of experience among sites
  • Leading or participating in various cross-functional and/or cross-site technical projects and teams related to drug product manufacturing, filling, and packaging.
  • May lead a project team, determining goals and objectives for the projects.
  • Providing technical support for all the activities related to drug product manufacturing, filling and packaging.
  • Working collaboratively develops harmonized data analysis processes and tools related to drug product manufacturing support, tech transfer and manufacturing innovation management.
  • Developing and driving innovation, best practices, and solutions for manufacturing
  • Initiates and completes technical activities leading to new or improved products or process, for current programs, next-generation programs and to meet strategic goals and objectives of the company.
  • Prepares reports, publishes, and makes presentations to communicate findings.
  • Leads investigations and report writing for both non-product impact and product impact deviations.
  • Develops sound Corrective Action Preventive Action (CAPA) plans and leads them to completion by leveraging resources and SME’s from various departments. Is responsible for change management that is required to close out the CAPA’s.
  • Incorporates business policies and procedures into task completion.
  • Cultivates internal and external network of resources to complete tasks.
  • Serves as a resource in the selection, orientation and training of new employees.
  • Interacts cross-functionally with internal and external customers.
  • Collaborative involvement in the generation of risk assessments focused on process improvements, regulatory compliance, and lean initiatives.
  • Identifies, plans and implements innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner. 
  • Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
  • Performs batch record reviews according to GMP and site quality standards.
  • Writes and revises-controlled documentation (SOP’s, Forms, Technical Reports, Batch Records, Protocols, etc.)

 

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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

 

III: Education, Experience & Skills

 

  • Bachelor degree in relevant field required or sufficient scientific and technical depth has been achieved from professional experience.
  • Minimum 3 years of GMP pharmaceutical experience
  • Demonstrated ability to collaborate and negotiate solutions in a fast-paced matrix environment, interacting with various levels of the organization.
  • Good quality orientation background with knowledge of cGMP’s, regulatory guidelines, and validation practices
  • Knowledgeable of application and practices of current GMP’s, international regulatory requirements and guidelines.
  • Possesses some knowledge of various technical alternatives and their potential impact on the business.
  • Exercises judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results

 

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.