Location: Winnipeg, MB, CA, R3T 5Y3
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.
ASSOCIATE BIOPROCESS SPECIALIST (CANADA)
Emergent BioSolutions is currently seeking an Associate BioProcess Specialist for our Manufacturing Department at our Winnipeg site location. The successful candidate will have a bachelor degree in a relevant field or sufficient scientific and technical depth from previous experience. Minimum of 3 years of GMP pharmaceutical experience, the demonstrated ability to collaborate and negotiate solutions and the knowledge of application and practices of current GMP’s, regulatory guidelines, and validation practices. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
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.
DUTIES & RESPONSIBILITIES
- 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
DUTIES & RESPONSIBILITIES
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.
EDUCATION, EXPERIENCE & SKILLS:
- Bachelor degree in relevant field required or sufficient scientific and technical depth 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
- Citizenship/Permanent Resident or Valid Work Permit.
- Successful Completion of a Criminal Record Check.
Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!