Job Description

Req #1137

Wednesday, April 19, 2023

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 has an opening for a Manager Production, Finish & Fill Operations. This is a permanent, full-time position located in Charlottetown, PEI.

The candidate will be responsible for:

• Leading Aseptic Vial production processes from receipt of Bulk Drug Substance through Aseptic Operations and final packaging of the Sterile Vial
• Operational understanding of manual, electronic, pneumatic, or computerized equipment to monitor and optimize process quality and efficiency in the Aseptic Processing Areas
• 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, EM/Micro, QA, maintenance, or technical operations. Scheduling and supervising the Fill Finish technicians to meet the required production schedule.
• Establishing Drug Product Fill/Finish departmental and individual expectations, provide direction and balanced performance feedback, coach, develop, and challenge reports, enforce company policies, and deal with personnel issues promptly. Maintain open communication via one-on-one and team/departmental meetings.
• Encouraging and oversee a culture of compliance regarding Safety, Environmental, and Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards / policies. This includes participating and supporting site regulatory audits and inspections.
• Providing regular process updates to internal or external project stakeholders.
• Creating and revising Batch Production Records or other related SOPs for precise match to process requirements and equipment capabilities. Managing manufacturing deviations, investigations, and Drug Product Fill/Finish Key Performance Indicators (KPI\'s).
• Engaging in cross-functional project teams and technology networks, interacting as a fully participating member, and representing process development issues and assumptions.
• Offering expert advice in troubleshooting equipment or processes and engaging required assets as required.
• Assuming primary accountability for managing Drug Product Fill/Finish assets and equipment.
• Additional duties assigned, based on business needs and the department supervisor\'s request.

The successful candidate for this position should have:

• Minimum B.Sc. degree, preferably with a discipline in Engineering, Chemistry, or Biochemistry
• M.Sc. or MBA preferred.
• 7+ years of relevant industrial experience with Aseptic Drug Product manufacturing, technical support of drug product manufacturing, or drug development experience with accomplishments at a biotechnology company.
• Minimum 5-7 years of experience in a supervisory role.
• Experience in a GMP Aseptic vial production environment working with pharmaceutical/biopharmaceutical equipment preferred.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the \xe2\x80\x9cApply Now\xe2\x80\x9d button.

Closing Date: May 19, 2023

Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply! We thank all interested parties; however, only those applicants considered for an interview will be contacted.

Other details

• Pay Type Salary

BioVectra