Upstream Production Manager
in Windsor, NS

Windsor, NS
Full-time - Permanent
Experienced
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Competition Number: Req #1031
Company Website: http://www.biovectra.com/

BIOVECTRA Inc. has an opening for an Upstream Production Manager.This is a permanent, full-time position located in Windsor, NS.

The candidate will be responsible for:

  • Providing technical leadership and hands-on technology development for existing product development projects; as required, articulating strategies to key clients.
  • Controlling fermentation processes from start-up to shutdown, isolating and preparing process units for production, cleaning or maintenance.
  • Operating manual, electronic, pneumatic or computerized equipment to monitor and optimize process quality and efficiency in the fermentation of drug products.
  • Reporting equipment problems to maintenance and follow up on any issues needed to resolve these problems on the production floor.
  • Scheduling and planning manufacturing operations to achieve project goals. Communicating and aligning other supporting resources such as QC, QA, maintenance or operations. Scheduling and supervising the fermentation technicians to meet the required production schedule.
  • Mentoring and managing the Fermentation Production Team: evaluating employees, hiring, training, leading team meetings and directing the workflow.
  • Providing regular process updates to internal or external project stakeholders.
  • Successful onboarding of new projects in Upstream in liaison with Technical Operations
  • Creating and revising Batch Production Records or other related SOPs for precise match to process requirements and equipment capabilities.
  • Engaging in cross-functional project teams and technology networks, interacting as a fully participating member, and representing process development issues and assumptions.
  • Ensuring that sound scientific discipline (scientific method, technical documentation, intellectual property management and peer review) is applied against all projects.
  • Offering expert advice in troubleshooting equipment or processes and engaging required assets as required.
  • Support internal, client and regulatory audits as SME for Upstream Manufacturing and ensure departmental readiness for the audit
  • Assuming primary accountability for managing laboratory fermentation assets.
  • Acting as the site Biological Safety Officer.
  • Conducting and promoting strong adherence to cGMP and data integrity principles.

The successful candidate for this position should have:

  • Minimum B.Sc. degree preferably with a discipline in Microbiology, Biochemistry, or Bio-Engineering
  • M.Sc. Considered an Asset
  • Five (5) years of relevant industrial experience with API and/or drug product manufacturing, technical support of drug product manufacturing or drug product development experience with technology transfer accomplishments in a biotechnology company.
  • Minimum Two (2) years' experience in a supervisory role
  • Working experience in a production environment working with biopharmaceutical equipment
  • Experience in fermentation process development, bench scale to large manufacturing
  • Thorough knowledge of current Good Manufacturing Practices (cGMP)
  • Thorough understanding of operations including manufacturing operation, supply chain, quality assurance, and quality control.
  • Thorough knowledge of ICH, FDA and relevant agency guidelines and requirements.
  • Ability to work in a fast-paced environment with minimal supervision
  • Ability to work and communicate in a dynamic, project driven team environment

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

Closing Date: December 15, 2022

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About BioVectra Inc.

BioVectra is a contract development and manufacturing organization (CDMO) that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients (APIs). With over 45 years of experience, we are a reliable and innovative partner, specializing in: 

  • Microbial Fermentation
  • Complex Chemistry
  • High Potency APIs
  • Biologics
  • Process & Analytical Development
  • Drug Development
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