PharmAllies Hiring for QC, Analytical Development, Scientist III (Biopharma) at Windsor, ON Full Time

THIS ROLE WILL REQUIRE New Hampshire RELOCATION

Full-Time Permanent Position

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Biopharma QC, Analytical Development, Scientist III

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Our team at PharmAllies has teamed up with a mid-sized pharmaceutical manufacturing firm to supply them with exceptional personnel (Full-Time Permanent Positions). This company has the experience, expertise, and a successful track record in delivering life-changing products and medical devices. Together with their clients, they treat many forms of cancers, diabetes, infectious diseases, and many other illnesses. Your work will matter, and your contributions will be significant in these endeavors. So make a difference, apply today!

JOB SUMMARY:

This position will have primary responsibility for supporting all activities within Quality Control Analytical Development, with special emphasis on supporting method transfers/validations and R&D projects utilizing cGMP knowledge and skills for analytical test methodologies and practices. This role is the third tier within the Analytical Development Scientist job family. At this level, the incumbent is expected to demonstrate advanced knowledge of commonly-used concepts, practices, and testing methodologies, demonstrating technical proficiency and scientific ingenuity as they carry out their duties in collaboration with analytical development team members and cross-functional colleagues. Additional areas of responsibility include but are not limited to performing cleaning validations and method verifications and writing instrument and method SOP’s as necessary.

JOB DUTIES:

• Perform routine and complex analytical testing of samples supporting process development.
• Develop, qualify/validate, optimize, and/or transfer analytical methods suitable of intended use, assuring project timelines are met
• Document/review laboratory work using laboratory notebooks/worksheets. Documentation is detailed, timely, and in compliance with Process Development requirements.
• Log and track samples and chemicals and order chemicals and laboratory supplies as needed.
• Troubleshoot assay methods and instrumentation issues as necessary ·
• Proactively identify assay issues, new assay needs and provide scientific suggestions and solutions.
• Author and/or review of GLP/GMP documentation following GDP requirements, including protocols, reports, and raw data
• Assist in bringing new technology and equipment into the QC lab.
• Mentor/guide junior Quality Control analysts on daily laboratory work, experimental design, data interpretation, and troubleshooting. Train new group members on analytical lab skills.
• Work independently with minimal supervision and direction.
• Other duties, as needed

PROFESSIONAL SKILLS:

• Must have excellent attention to detail and the ability to work in a cross-functional team environment.
• Highly advanced organizational skills and the ability to work within a fast-paced environment
• Multi-disciplinary knowledge of Quality Control
• Advanced capability for logical, analytical, and strategic thinking
• Problem analysis and resolution skills required experience working in a laboratory under cGMP, ICH, USP, or global compendial regulations and guidance, particularly as related to analytical method development and validation
• Highly effective and capable of presenting technical data to guide and influence
• Advanced skills in MS Office and lab-based data management systems

• Scientific, technical writing ability, including authoring and revising SOPs or technical reports
• Highly skilled at the troubleshooting of assay and equipment issues

EXPERIENCE:

• 10+ years Experience in a cGMP organization
• Experience working in a contract manufacturing/development environment preferred.
• Experience working in a cGMP laboratory environment is highly preferred.
• Proficiency with performing analytical testing using several of the following types of equipment: HPLC/UPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Osmometer, pH required.
• Experience in Analytical Method Development and/or Validation is preferred

EDUCATION:

• Bachelor’s degree in a scientific field with 10 or more years experience in a cGMP laboratory environment

TRAVEL:

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Job Type: Full-time

Pay: From $1.00 per year

Additional pay:

• Bonus pay

Benefits:

• Dental care
• Paid time off
• Vision care

Schedule:

• 8 hour shift

Application question(s):

• Are you authorized to work in the United States?
• Will you now; or in the future, require out company to commence(sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
• Are you willing to relocate to New Hamshire?

Experience:

• QC Analytical Development: 10 years (preferred)
• Validation and R&D: 10 years (preferred)
• lab-based data management systems: 10 years (preferred)
• Scientific technical writing: 10 years (preferred)
• HPLC/UPLC, GC, FTIR, UV/VIS, & Karl Fisher: 10 years (preferred)