Job Title

Requisition

Location

Additional Locations

Job Description

Job Summary

To support the expansion of small molecule API R&D development capabilities within Mallinckrodt's Specialty Generics business, this new position within the API Development and Support organization will be responsible for development of new API chemical processes.

Essential Functions:

• Works in a fast-paced, results-oriented team environment to provide creative solutions to drive new API development.
• Identifies route selections for target API molecules amenable to fast and efficient scale-up to commercial production.
• Possesses knowledge and skillset base to develop and scale-up commercially viable, safe, environmentally friendly, and robust API chemical processes.
• Interacts effectively with Manufacturing, Engineering, Safety organizations as well as other members of the API development team.
• Familiar with DOE and QbD techniques to create optimal API manufacturing processes.
• Possesses an understanding of engineering principles as it relates to target molecule route selection and development.
• Provides excellent understanding of FDA Q7A GMP principles and requirements for successful regulatory filings.
• Performs assigned tasks using own discretion and judgment as to the specific approach or technique.
• Demonstrates 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:

• Familiarity with the following preferred:
  • Latest pharmaceutical process chemistry and technologies
  • Process analytical technology (PAT)
  • 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 at least 8 years of relevant API development experience.
  • MS (thesis preferred) with at least 5 years of relevant API development experience.
  • PhD in Chemistry with at least 3 years of relevant API development experience.

Preferred Skills/Qualifications:

Solid organic synthesis knowledge and understanding of the fundamental aspects of complex chemistries and processes. Considerable hands-on experience with route selection, process development, validation, and commercial technical transfer is required. Experience with unit operations and ability to effectively interact with manufacturing chemical engineers. Proven ability and desire to solve technically complex problems. Knowledgeable in cGMP and FDA guidelines. Experience in 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 direct or manage various projects and to contribute / facilitate team investigations. Demonstrated ability to work well in a fast-paced team setting, especially in a resource limited environment. Must be able to contribute to projects and operate with limited supervision.

Relationship with Others:

Interaction with other API Development and Support team members is common. May collaborate on joint projects. Will interact, from time to time with manufacturing plant leaders/managers.

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.