BioProcess Specialist

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 - 1 YEAR, 5 MONTH TERM

The BioProcess Specialist provides strategic and operational support to the Production organization to ensure efficient manufacturing processes, optimize existing workflows, and help achieve production targets. You will serve as a key interface between various teams to successfully integrate new products and processes into the manufacturing environment.

The primary objectives of this role is to:

• Ensure harmonized process performance and consistent product quality across production sites.
• Facilitate robust and streamlined process transfers within the manufacturing network.

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

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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.

   

• Analyzes and solves problems from basic scientific principles, theories and concepts 
• Incorporates business policies and procedures into task completion. Understands the business needs of the company and has knowledge of the customer needs of our business. Understands the business cycle and foresight of emerging technologies trends.
• Cultivates internal and external network of resources to complete tasks.
• Serves as a resource in the selection, orientation and training of new employees.
• Mentors employees by sharing technical expertise and providing feedback and guidance.
• 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.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Bachelor degree in relevant field or sufficient scientific and technical depth has been achieved from professional experience.
• 5 years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience.
• Demonstrated ability to collaborate and negotiate solutions in a fast-paced matrix
  environment, interacting with various levels of the organization
• Strong quality orientation with extensive knowledge of cGMP’s, regulatory guidelines and validation practices
• Comprehensive knowledge of a particular technological field.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

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.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. 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.