Group Leader - Biologics
AI Summary
Manages a group of biologics analysts and scientists, coordinating project workloads, scheduling, and resource allocation while ensuring compliance with cGMP/GLP standards. Leads investigations for test failures, writes and reviews technical protocols and reports, and manages staff performance and client proposals. Executes experiments and analyzes testing data using laboratory instruments and electronic systems.
About this role
Group Leader - Biologics
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
- Monitor and maintain the flow of work and schedule daily/weekly activities of staff
- Provide weekly, monthly or as required team updates to the Department Head. This includes safety reports, revenue reports, resource allocation summaries, improvement and new business opportunities, general concerns and any other business.
- With aid of Department Head, manage staff performance, personnel issues, concerns, etc.
- Manage resource allocation and project prioritization and work across groups and functions to manage resources efficiently.
- Write, review, and approve protocols, drafts methods and technical reports. Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute CAPA.
- Evaluate client requests, scope of work plans and provide customer proposals for their work.
- Write and review technical data, documents, SOPs and proposals as required.
- Executes experiments, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
- Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in timely manner.
- Coordinate method transfers between clients and SGS.
- In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.
- Maintain analyst and scientist work schedule and project plans in accordance with project timelines and key milestones.
- Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer.
Qualifications
- BSc or MSc/PhD with bioseparations experience
- Experience with the following instruments: HPLC, UPLC, Mass Spec, Electrophoresis
- Elisa, qPCR, ddPCR,Enzyme Activity assays, SPR, BLI Sanger sequenecing an asset.
- 5+ years with demonstrated ability to complete more complex role/duties
- Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
- Demonstrated understanding of cGMP/GLP
- Ability to coordinate and manage a group and its workload.
- Ability to critically interpret and analyze data
- Able to read, understand, communicate and follow work instructions in a safe, accurate and timely manner.
- Capable of interacting with all levels of management, suppliers and clients.
- Proven time management skills and a strong attention to detail.
- Extended hours and shift work may be required from time to time
Additional Information
Salary Range: $65,000 to $90,000 CAD
Some Benefit Highlights:
- 80% coverage Health, Dental and Vision
- Paid time off
- RRSP Program Eligibility
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression and Indigenous status, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.
Skills
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