Position Overview
This position requires both supervisory and technical experience. Responsible for overall project leadership and serves as point of contact for client consultation and technical review of studies. Required to develop and validate new methodology and novel approaches to problem solving for analysis of constituents in testing matrices (including but not limited to, container closure systems, single use bio-process systems, drug products). Responsible for method transfer in a coherent manner to subordinate chemists while adhering to appropriate regulatory requirements, including applicable SOP’s, ICH Guidelines, US FDA, EMEA, US EPA Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
Critical Performance Areas
- Responsible for overall supervision of HRAM group, and direct supervision of chemists to include training, career development and performing employee reviews.
- Responsible for overall project leadership of studies and collaboration across analytical groups.
- Accurately record and document raw data, observations and pharmacy usage.
- Ensure that work conforms to appropriate regulatory requirements, including SOP’s, US FDA and US EPA Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards
Requirements
- BA/BS degree in related science (advanced degree in Chemistry is preferable) and/or 5+ years experience.
Demonstrates leadership ability.
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Other Desired Skills/Abilities
- Strong written and verbal communication skills.
- Capable of multi-tasking.
Working knowledge of extractable/leachables conducted under PQRI, BPSA, ISO & BPOG guidelines.
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Reporting Structure
This job typically reports to:
Senior Manager, Analytical Services and/or Director, Analytical Services
NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer: Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
This role is budgeted for a base salary cap of $110,000.
Requirements
- BA/BS degree in related science (advanced degree in Chemistry is preferable) and/or 5+ years experience.
Demonstrates leadership ability.
-
Other Desired Skills/Abilities
- Strong written and verbal communication skills.
- Capable of multi-tasking.
Working knowledge of extractable/leachables conducted under PQRI, BPSA, ISO & BPOG guidelines.
-
Reporting Structure
This job typically reports to:
Senior Manager, Analytical Services and/or Director, Analytical Services
NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer: Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
This role is budgeted for a base salary cap of $110,000.
Essential Job Functions
- Develop and validate new methodologies for analysis of trace constituents in testing matrices (liquids & solid).
- Advanced knowledge of analytical chemistry, to include knowledge of structural elucidation using MS techniques, and regulatory compliance pertinent to the work being completed.
- Preparation for analysis of samples, in a variety of matrices, using chromatographic and spectroscopic techniques.
- Responsible for overall direction and completion of studies, including making key recommendations to management regarding study performance, providing study timelines and writing study protocols and standard operating procedures.
- Properly execute instrument validation and method development procedures.
- Effectively interact with management, senior staff members, co-workers and external contacts.
- Strict adherence to Lab Safety Guidelines and demonstrate chemical safety, proper chemical use, chemical labeling and storage.
- Accurately project staff and additional resource needs to management in a timely and effective manner.
- Ensure accurate and timely completion of employee timesheets.
Essential Job Functions
- Develop and validate new methodologies for analysis of trace constituents in testing matrices (liquids & solid).
- Advanced knowledge of analytical chemistry, to include knowledge of structural elucidation using MS techniques, and regulatory compliance pertinent to the work being completed.
- Preparation for analysis of samples, in a variety of matrices, using chromatographic and spectroscopic techniques.
- Responsible for overall direction and completion of studies, including making key recommendations to management regarding study performance, providing study timelines and writing study protocols and standard operating procedures.
- Properly execute instrument validation and method development procedures.
- Effectively interact with management, senior staff members, co-workers and external contacts.
- Strict adherence to Lab Safety Guidelines and demonstrate chemical safety, proper chemical use, chemical labeling and storage.
- Accurately project staff and additional resource needs to management in a timely and effective manner.
- Ensure accurate and timely completion of employee timesheets.
