Process Development Scientist, Analytical Services

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 Process Development (PD) Analytical Services Scientist must have knowledge of analytical or bioanalytical chemistry and possess problem solving skills with the ability to work independently. Process Development Analytical Services Scientists will provide timely analytical support to other PD groups during the development stage of projects, with the long-term goal of transferring the technologies to the Quality group. Additionally, the Process Development Analytical Service Scientists will be responsible for performing laboratory activities in a manner compliant with the internal quality systems.

ESSENTIAL FUNCTIONS:

• Development and qualifications of HPLC methods is required.

• Carrying out literature searches as appropriate to evaluate currently known    analytical methods and preparing analytical research and development plans as required.

• Providing timely analytical support for process development projects.

• Developing  appropriate   in-process  QC  procedures   in   conjunction  with  Process  Development Scientists.

• Developing modern analytical methodologies using quality by design (QbD) and design of  experiments (DoE) methodologies to identify and understand design space and critical instrument parameters

• Training and supervising fellow scientists, technicians and students in analytical methodology.

• Transferring technology to technical staff, as a member of the project team working effectively with both the Process Development and Quality groups.

• Maintaining accurate, real-time records of all laboratory activities.

• Executing assigned housekeeping responsibilities.

• Following  the  company’s  quality  standard  (quality  management  system  procedures  and cGMP regulations).

• Preparing purified analytical standards if required.

• Complying with documented safety practices for the laboratory and the manufacturing facilities.

• ·Adhering to BIOVECTRA’s Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.

• Additional duties assigned, based on business needs and the department supervisor’s request.

Qualifications

MINIMUM REQUIREMENTS:

• Bachelor of Science in Chemistry
• Master or Ph.D. in Chemistry strongly preferred.
• Must have hands-on knowledge and skills in using High-Performance Liquid Chromatography (HPLC)
• 3+ years of relevant experience.
• ·Knowledge of Process Analytical Technology an asset
• Knowledge of cGMP guidelines and regulatory requirements as asset
• Strong technical writing an asset
• Proficient communicator, both written and oral.
• Knowledge of current Good Manufacturing Practices (cGMP)
• Excellent computer, organizational, leadership and interpersonal skills.
• Ability to interpret and analyze data.
• Ability to multi-task and interchange when required.
• Technical proficiency with laboratory instrumentation and techniques.

Work Conditions:

·    Chemical odors.

·    Flexible work hours required, evening or weekend shifts may be scheduled.

·    Potential for handling of potent compounds.

·    Potential for handling biohazardous compounds.

·    Required to use a respirator.

CORE COMPETENCIES:

·    Leadership

·    Ownership Thinking

·    Communication

·    Problem Solving

·    Teamwork

Additional Details

This job has a full time weekly schedule.

The full-time equivalent pay range for this position is $63,345.00 - $98,976.00/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/locations

Agilent 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: R&D