BioVectra Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.
BioVectra Inc. has an opening for a Purification and Downstream Processing Manager. This is a permanent, full-time position located in Windsor, NS.
The candidate will be responsible for:
· Leading process development, scale up and technology transfer from Process Development to GMP manufacturing
· Establishing product specifications, selects materials and executes risk assessment
· Development of and approval of associated process SOP’s, training documents, and associated reports
· Facilitating alignment of development and operations technical decisions necessary through completion of process performance demonstration, engineering and validation runs to ensure commercial viability of the manufacturing process
· Managing manufacturing investigations
· Managing process characterization and advances bioprocess technology
· Overseeing and coordinating, in conjunction with other manufacturing teams, engineering, quality control and other stakeholders the development, scale-up and manufacturing of projects; including development of budgets, time lines, and quality guidelines.
· Coordinating, prioritizing and managing multiple projects.
· Developing, utilizing and reporting metrics for the performance of the downstream processing group
· Leading, identifying and setting goals for the downstream processing group.
· Administering HR policy with respect to subordinates.
· Supporting regulatory filings and inspections
The successful candidate for this position should have:
· Minimum B.Sc. degree preferably with a discipline in Chemistry, Biochemistry, or Chemical Engineering; M.Sc. an asset
· 10 years of relevant industrial experience with API and/or drug product manufacturing, with technology transfer and manufacturing experience.
· Thorough knowledge of current Good Manufacturing Practices (cGMP)
· Thorough knowledge of ICH, FDA and relevant agency guidelines and requirements.
· Demonstrated leadership, project management experience with cross-functional team direction skills.
· Excellent verbal, written, interpersonal, and organizational skills
· Experience in technology transfer accomplishments in a biotechnology company.
· Willingness to travel when necessary.
Closing Date: December 13, 2017
We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.