Hiring Manager: William Antos

Recruiter: Kathleen Jackson

The Sr. Scientist, Analytical Research leads and performs method validation activities in support of an assigned project. This includes generation of method validation protocols, laboratory work, and generation of method validation reports. May be asked to lead and perform method development work on less complex projects (i.e., monographed products, less complex molecules, less complex dosage forms). In addition, the Scientist III will conduct testing for stability studies, API characterization work, and product development as assigned.

Reviews and checks analytical data generated by peers and maintains integrity of data. Troubleshoots and improves analytical methods. Coordinates analytical activities to meet the business deadlines. Directs and mentors scientists with minimal management oversight. Introduces new ideas and/or technologies. Documents analytical activities and results accurately, in a timely manner and right-first time.

Responsibilities

Serves as the analytical lead for method validation activities and completes all work in accordance with the project plans, in compliance with cGMP, and company procedures. May be asked to lead method development work on less complex projects.

Performs analytical review, trending, and assessment of data. Is accountable for accuracy of data in reports and other summary documents.

Proactively participates in activities in support of process changes. Suggests and leads process improvements to refine current systems and improve efficiency. Propose and implement new technologies. Mentors peers in method development, validation, troubleshooting, instrumentation, laboratory practices, and processes.

Conducts trainings on selected topics of interest for the department and may be a subject matter expert on technologies/processes/techniques.

Communicates effectively with peers, management, internal/external customers and regulatory agencies. Monitors project status and proactively communicates to supervisor and stakeholders. Participates and represents the department in cross-functional teams.

Experience in U/HPLC is required. Understanding in two of the following techniques is preferred: DSC/TGA, DVS, MS, GC, XRD, Inhalation/Nasal, Elemental Analysis, NIR, Raman, Particle size, Imaging techniques and other relevant analytical technologies.

Knowledge of the critical functions/variables of analytical techniques, and proven ability to troubleshoot methods is also required.

Knowledge of the most current FDA/ICH guidance’s, national Pharmacopoeias, and cGMP regulations is preferred. Basic understanding of analytical regulatory requirements for ANDA/NDA submissions is preferred.

Must be able to work independently and in a team environment. Coaching skills are required.

Must possess the ability to work on multiple tasks in a fast pace environment. Project management and organizational skills are required.

Must possess good written and verbal communication skills.

The candidate must have the ability to work with minimal supervision using scientific judgment and professional competency.

Problem solving ability is required.

Qualifications

• PhD in a scientific discipline with 0-3 years of experience in a regulated laboratory environment; or MS in a scientific discipline with a minimum of 3 years of experience in a regulated laboratory environment; or BS/BA in a scientific discipline with a minimum of 5 years of experience in a regulated laboratory environment.
• Ph.D, MS, or BS in Chemistry preferred.
• Experience in method validation is required.

• Experience in method development is preferred. Experience working in a GLP/GMP environment is highly preferred

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match, up to 6% of your contributions
• 23 paid time off/personal days (prorated based on hire date)
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

• Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.