Sr. Engineer II, Technical Development

Job Description

Duties:

• Participate in multidisciplinary team responsible for conducting process and formulation development of pipeline products and for supporting commercial products through life cycle management.
• Design, plan, execute and document formulation and process development studies, with an emphasis on oral solid dosages;
• Apply scientific/engineering principles and techniques to develop, characterize, and implement processes and next generation technologies to solve technical challenges.
• Provide support, as needed, to clinical drug product manufacturing through process capability analysis and product impact assessments for process changes/improvements and nonconformance investigations;
• Author / review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.

50% travel required (domestic and international).

Qualifications

Minimum Requirements:

PhD. degree or foreign equivalent in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or a related field and

2 years of experience in the job offered or in a Sr. Engineer II, Technical Development-related occupation.

In the alternative, the employer will accept a Master's degree (or foreign

equivalent) in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Material Science, Engineering, Chemistry or related field and 5 years of experience in the job offered or in a Sr. Engineer II, Technical Development - related occupation.

Position requires 24 months of experience in the following:

• Oral solid dosage formulation and process development, process characterization, technical transfer to manufacturing sites of CMOs, and technical writing;
• Hands-on experience with unit operations involved in manufacture of oral solid dosages;
• Small molecule parenteral formulation and process development; and
• Demonstrated ability of utilizing innovative tools and approaches for formulation and process characterization and development.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.