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Associate Bioprocess Specialist Jobs
Company | Emergent BioSolutions |
Address | Winnipeg, Manitoba, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology |
Expires | 2023-07-18 |
Posted at | 11 months ago |
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.
- Prepares reports, publishes, and makes presentations to communicate findings.
- Harmonize technical support for production sites and manufacturing processes within the network
- Providing technical support for all the activities related to drug product manufacturing, filling and packaging.
- DUTIES & RESPONSIBILITIES
- Working collaboratively develops harmonized data analysis processes and tools related to drug product manufacturing support, tech transfer and manufacturing innovation management.
- 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.)
- Developing and driving innovation, best practices, and solutions for manufacturing
- Leading or participating in various cross-functional and/or cross-site technical projects and teams related to drug product manufacturing, filling, and packaging.
- Serves as a resource in the selection, orientation and training of new employees.
- Leads investigations and report writing for both non-product impact and product impact deviations.
- Interacts cross functionally with internal and external customers.
- 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.
- Incorporates business policies and procedures into task completion.
- Ensure harmonized process performance and product quality
- Collaborative involvement in the generation of risk assessments focused on process improvements, regulatory compliance, and lean initiatives.
- May lead a project team, determining goals and objectives for the projects.
- 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.
- Cultivates internal and external network of resources to complete tasks.
- Main objectives are:
- 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.
- Monitors process performance and interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Champion, promote and coordinate manufacturing innovation and sharing of experience among sites
- 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.
- Minimum 3 years of GMP pharmaceutical experience
- Bachelor degree in relevant field required or sufficient scientific and technical depth achieved from professional experience.
- Good quality orientation background with knowledge of cGMP’s, regulatory guidelines, and validation practices
- Possesses some knowledge of various technical alternatives and their potential impact on the business.
- Demonstrated ability to collaborate and negotiate solutions in a fast-paced matrix environment, interacting with various levels of the organization.
- Exercises judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
- Knowledgeable of application and practices of current GMP’s, international regulatory requirements and guidelines.
- Successful Completion of a Criminal Record Check.
- Citizenship/Permanent Resident or Valid Work Permit.
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