Job Details

Manager, Purification and Downstream Processing

Title
Manager, Purification and Downstream Processing
Length
Full Time
Salary
not disclosed
Employer

BioVectra

Location
Windsor
Nova Scotia
Date Posted
01/12/2017 - 07:45
Closing Date
01/01/2018 - 07:45
Job Description
Summary: 

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 Manager, Purification and Downstream Processing.  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.

 

BioVectra offers a competitive salary and benefit package. . Interested candidates are asked to apply by choosing the “Apply Now” button below.

Closing Date: December 15th, 2017

We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.

 

Other Information: 

Please apply at www.biovectra.com