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Manager, Lab Operations

Location: 

Winnipeg, MB, CA, R3T 5Y3

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. 

 

MANAGER, LAB OPERATIONS

 

Emergent BioSolutions is currently seeking a Manager, Lab Operations for our Winnipeg location. The successful candidate will have a University degree or technical diploma in biology, immunology, chemistry or another related field of study and have a minimum of 7 years of directly related experience. Must have strong technical writing capabilities, strong communication skills, demonstrated technical competence and strong organizational and interpersonal skills. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

The Manager, Lab Operations manages the routine plasma donor screening for development programs and approved programs requiring testing done in BIAD. This role works with subject matter experts (SMEs) in BADV to monitor assay performance and implement changes if needed. In addition, they also manage/coordinate QC release/stability testing done in BADV.

The Manager supports our Quality system with SME’s across BADV for LIRs, CAPA, deviation, etc. This role is responsible for instrument and equipment, Capex approvals, qualifications, software validation, and yearly re-qualifications. In addition, they will also manage the general lab operations, maintenance, cleaning, GXP compliance infrastructure, etc.

 

DUTIES & RESPONSIBILITIES

 

  • Responsible for leading, mentoring, developing scientists in the Lab operations group through hiring, onboarding, performance review, and ongoing training and talent development. 
  • Develop and coach direct reports to achieve goals and results by optimizing resources and building team capabilities/effectiveness.
  • Regularly communicates corporate mission/values, portray the values, and recognize staff exhibiting the values and hold people accountable if values are not exhibited.
  • Work with cross-functional teams and department leadership to direct the work activities for unit staff to ensure that corporate, project and unit objectives are completed efficiently within defined timelines.
  • Design and implement plans and procedures such that work areas meet all company policies and standards for hygiene, safety and security and lab activities are conducted according to safety guidelines, policies and legislation.
  • Review and approve unit procedures relating to testing, sampling, or related analytical operations.  
  • If required, provide data and support including technical writing for regulatory submissions (INDs, BLAs, etc.). Represent functional area as a subject matter expert in meetings, telecons, etc, with regulatory agencies
  • Define and provide clarification on unit objectives based on corporate objectives and cascade to unit staff for setting individual goals in-line with departmental and corporate objectives.
  • Contribute to departmental strategy and manage lab requirements and improvements.
  • Contribute and manage annual operating and capital budgets within their scope for the department, including approval of purchase requisitions.
  • Contribute to project-specific budgets to support existing contracts or budgets and if required, technical narrative for new proposals/work packages.
  • Ensure that laboratories and procedures are in compliance with GLP/GMP requirements, participate in internal and external/regulatory audits and manage corrective actions/responses.
  • Coordinate/support sample testing performed at external CRO’s/CMO’s.

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned. 

  
EDUCATION, EXPERIENCE & SKILLS: 

 

  • University degree or technical diploma in biology, immunology, chemistry or related field of study.
  • Minimum of seven years directly related experience in a recognized professional or technical/scientific field. Previous experience in a leadership role preferred.
  •  Experience in a pharmaceutical/biopharmaceutical cGXP environment.
  • Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
  • Proficient and professional communicator, verbally and in writing.
  • Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
  • Strong organizational and interpersonal skills and the ability to work collaboratively with others.
  • Proficient in complex procedures and problem solving.
  • Proven ability to manage with leadership and independence with a focus on excellence, innovation, and teamwork.
  • Proficient in Microsoft Office including Word, Excel, PowerPoint, Outlook, and Teams.
  • Comprehensive knowledge of pharmaceutical GLPs and GMPs.
  • Comprehensive knowledge of laboratory techniques and safety precautions.
  • Comprehensive knowledge of WHMIS and biohazard safety.
  • Comprehensive knowledge of regulatory/industry guidance.

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.