Sr Engineer IMfg Scientist I Manufacturing Sciences Parenteral Filling

This is a full time onsite 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 Youll 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/scaleup 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: Bachelors degree plus minimum 4 years of relevant experience in the Biotech / Biopharm industry or Masters 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 fullscale 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 crossfunctional group

Additional Information :

The base salary range for this position is $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 longterm 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 wellbeing; including but not limited to:

• Medical Dental Vision & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short and LongTerm Disability insurance
• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 $10000 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.