Sr Synthetic Chemist

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Job Description

The Senior Synthetic Chemist position within the API Development and Support organization synthesizes analytical reference standards in support of API chemical processes, responds to reference standard technical inquiries, provides technical support for GMP API manufacturing, optimizes existing API chemical processes, and develops new API chemical processes.

Essential Functions:

• Works in a fast-paced, results-oriented team environment to provide unique solutions to internal and external customers' needs.
• Identifies synthetic pathways to target API molecules using vast synthetic knowledge and support from literature.
• Key contributor in the development and optimization of new and existing API's.
• Applies knowledge and skillset to develop efficient, safe, environmentally friendly, and robust API chemical processes.
• Works effectively with engineering, safety, and analytical groups to oversee scale-up and manufacturing of various opioid and non-opioid API's.
• Supports continuous improvement initiatives for manufacturing processes.
• Provides troubleshooting and technical support in timely manner across Manufacturing, Quality, Regulatory, and Safety functional groups.
• Performs assigned tasks using own discretion and judgment as to the specific approach or technique.
• Demonstrates strong knowledge in scientific techniques, theory, troubleshooting, etc.
• Demonstrates excellent verbal and written communication skills.
• Remains compliant with company, site, and safety policies and procedures.
• Must be able to work with controlled substances.

Department Specific / Non-Essential Function:

• Represents process chemist function as team member for projects.
• Familiarity with the following preferred but not required:
  • FDA Q7A Good Manufacturing Practice Guidance for API's
  • ICH guidelines
  • Requirements of various pharmacopeias (USP, EP, JP)
  • Controlled substance handling

Minimum Requirements:

• Education/Experience:
  • BS in Chemistry with a minimum of 5 years of related industrial experience.
  • MS (thesis preferred) with a minimum of 3 years of related industrial experience.
  • PhD in Chemistry

Preferred Skills/Qualifications:

Solid organic synthesis knowledge and understanding of the fundamental aspects of complex chemistries and processes. Hands-on experience with process development, validation, and commercial technical transfer is preferred. Ability to effectively interact with manufacturing chemical engineers. Proven ability and desire to solve technically complex problems. Understanding of analytical techniques such as IR, MS, NMR, and HPLC.

Skills/Competencies: Self-starter with strong work ethic, excellent written and verbal communication skills, the ability to successfully manage various projects and contribute to team investigations. Ability to work well in a fast-paced team setting, especially in a resource limited environment. Should be able to operate with limited supervision.

Working Conditions:

Typical laboratory conditions. Employees are required to wear eye protection and lab coats while in the lab area. Occasional handling of potent compounds or hazardous chemicals may require the use of additional PPE. Drug Enforcement Administration (DEA) regulated workplace. The employee occasionally lifts and/or moves up to 25 lbs.