About this role
Job Description
BIOVECTRA, now a part of Agilent, is recognized as a leader in the contract development and manufacturing space of active pharmaceutical ingredients specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharma and biotech companies.
BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics.
The Manager of Quality & Regulatory oversees a dynamic team of microbiologists and environmental technicians to provide timely and accurate microbiological testing and environmental monitoring in support of the manufacturing of pharmaceuticals.
- Developing senior members of their team in their roles and mentoring them in their careers
- Collaborating with manufacturing, engineering, and the other members of the Quality team for the continuous improvement and refinement of our manufacturing process to provide our clients and patients with safe, effective products.
- Designing, outlining and executing investigation plans to determine the root cause and prevention of microbial contaminants/environmental isolates.
- Writing, reviewing and approving Quality Control deviations.
- Organizing and prioritizing department workflow.
- Ensuring follow up actions arising from quality system events including but not limited to audits, corrective action plans, deviations and out of specification investigations are completed and documented.
- Seeking continuous refinement and improvement of departmental SOPs to ensure facility wide compliance and following current good manufacturing practices
- Taking a lead role in overseeing the day-to-day activities of the quality control microbiology laboratories and maintaining the highest standards of quality.
- Building and maintaining close communication with clients and project managers on microbiological and environmental monitoring issues.
- Implementing continuous improvement of departmental SOPs to ensure compliance with USP<61>, <62>, and <71> other compendial microbiological test methodologies.
Qualifications
- B.Sc. in Microbiology or related field.
- Prior team management and leadership with a minimum of supervisory experience is required.
- MSc or PhD are considered an asset.
- Experience leading and developing a team in a high throughput environment.
- Ability to relay scientific information to project managers and clients through presentations.
- Previous experience in a regulated microbiology lab.
- Experience with manufacturing contamination control strategy.
- Technical proficiency with qualifications of laminar flow hoods and BSC’s.
- Experience with laboratory instrumentation such Vitek II, Growth Direc.t
- Experience with microbial speciation.
- 10+ years of Quality and Regulatory experience.
Additional Details
This job has a full time weekly schedule.The full-time equivalent pay range for this position is $110,186.00 - $172,166.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required:
OccasionalShift:
DayDuration:
No End DateJob Function:
Quality/RegulatoryOther facts
About Agilent Technologies
Agilent customers are finding new ways to treat cancer, ensure food, water, air, and medicine quality and safety, discover new drug treatments, research infectious diseases, and create alternative energy solutions for a greener planet. From start to finish, we have them covered with our vast product solutions and services portfolio.
Around the world, Agilent’s people bring innovations, technologies, and services to the forefront of science. Our teams design and manufacture a wide array of advanced analytical, research, and diagnostic solutions and tools for use inside and outside laboratories.
Additionally, the unique expertise of Agilent’s CrossLab and technical teams provides valuable insight and support to our customers, helping them fully optimize their laboratories and resources to better focus on what's important: bringing great science to life.
In fiscal 2022, Agilent Technologies generated revenue of (US) $6.85 billion.
What you'll do
- The Manager of Quality & Regulatory oversees a team to ensure timely microbiological testing and environmental monitoring for pharmaceutical manufacturing. They are responsible for continuous improvement of processes and compliance with quality standards.
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