Manager, HRAM

About Us

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.

About the Role

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).

Responsibilities

• Develop and validate new methodologies for analysis of trace constituents in testing matrices (liquids & solid).
• Apply advanced knowledge of analytical chemistry, including structural elucidation using MS techniques and regulatory compliance pertinent to the work.
• Prepare and analyze samples in a variety of matrices using chromatographic and spectroscopic techniques.
• Provide 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.
• Execute instrument validation and method development procedures.
• Interact effectively with management, senior staff members, co-workers, and external contacts.
• Adhere strictly to Lab Safety Guidelines and demonstrate chemical safety, proper chemical use, chemical labeling, and storage.
• Project staff and additional resource needs to management in a timely and effective manner.
• Ensure accurate and timely completion of employee timesheets.
• Supervise the HRAM group, including training, career development, and performing employee reviews.
• Ensure work conforms to appropriate regulatory requirements, including SOP’s, ICH Guidelines, US FDA, EMEA, US EPA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP).
• Accurately record and document raw data, observations, and pharmacy usage.

Requirements

• BA/BS degree in a related science (advanced degree in Chemistry is preferable) and/or 5+ years of experience.
• Demonstrated leadership ability.

Skills

• Strong written and verbal communication skills.
• Capable of multi-tasking.
• Working knowledge of extractable/leachables conducted under PQRI, BPSA, ISO & BPOG guidelines.

Pay

This role is budgeted for a base salary cap of $110,000.

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.