Sr Engineer I/Mfg Scientist I, Manufacturing Sciences (Parenteral Filling)

Job Description

This is a full time on-site position

The Sr. Engineer I, Manufacturing Sciences will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run at the Biogen RTP Pharma site, Parenteral Filling facility.

What You’ll Do

• Apply knowledge of parenteral filling operations, lyophilization, and visual inspection activities
• Lead Process Transfer teams, technical improvement projects, and technical process investigations as needed
• Provide decisions for manufacturing implementation; communicate analysis and decisions to the technology transfer team
• Provide technical and operational guidance to Manufacturing during GMP campaigns
• Lead technical investigations towards process impact assessments and ensure timely completion and communication
• Author Manufacturing and Process Performance Qualification validation protocols and technical reports
• Improve MS business systems
• Lead technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding
• Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate
• Subject matter Expert to support inspections and audits

Qualifications

• Required degree in Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline: Bachelor's degree plus minimum 4 years of relevant experience in the Biotech / Biopharm industry or Master's degree plus minimum 2 years of industry experience
• Solid technical understanding of Parenteral Filling Operations is required (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities
• Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
• Good communication and project management skills appropriate for leadership of tech transfer projects
• Excels at working in a team environment
• Comfortable analyzing scientific datasets
• Ability to work independently and lead a large cross-functional group

Additional Information

The base salary range for this position is $95,000-124,000 annually. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.