Senior Analytical Chemist

Company Description

We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

Job Description

Responsible for the design, development, qualification, validation, and implementation of analytical procedures in support of research, GMP production, and stability testing.  The Senior Analytical Chemist is expected to provide quality ideas and contribution to the assigned challenges and to offer recommendations and knowledge to other Veranova staff.

PRINCIPAL ACCOUNTABILITIES

• Develops efficient and selective analytical procedures (with emphasis on HPLC and GC) for assigned projects.
• Prepares qualification and validation protocols and reports for analytical procedures and instrumentation.
• Performs sample analysis and reviews data packages.
• Documents all analyses per SOPs.
• Prepares high quality written documentations (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation.
• Troubleshoots analytical instrumentation.
• Communicates effectively in verbal and written form on research results and plans.
• Volunteers to assist with task not directly related to a specific project.
• Demonstrates initiative in handling responsibilities.
• Contributes to the technical growth of the department and company.
• Attends project meetings and prepares project updates.
• Participates in self-development activities.
• Other duties as assigned.

 QUALITY/REGULATORY RESPONSIBILITIES

• Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
• Applies cGMP concepts in association with department specific responsibilities.
• Ensures all documentation produced is in compliance with cGMP standards.
• Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

 ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES

• Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities.
• Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards.
• Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
• Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated. 
• Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
• Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities.

 PHYSICAL DEMANDS & WORK ENVIRONMENT

• While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
• Must be able to lift and/or move up to 50 pounds.
• Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
• Regularly works with moving mechanical parts and may work with toxic or caustic chemicals.  The work may be performed in humid areas with low or high temperatures.

Additional Information

ESSENTIAL

• BS in Analytical Chemistry or equivalent with 5-7 years related experience in a pharmaceutical industry.
• MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry.
• Ability to write clear and concise technical reports.
• Good understanding of Microsoft Office and statistical software.
• Demonstrates ability to exercise good judgment and make decisions quickly.
• Good written and verbal communication skills.
• Experience with common analytical techniques such as HPLC, GC, LC-MS,