Sr. EngineerScientist III, Manufacturing Sciences
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 131000 - 175000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
About the Role
As a member of Manufacturing Sciences the Sr. Engineer III will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish visual inspection and packaging.
The Sr. Engineer III Manufacturing Sciences will provide technical expertise to the clinical PPQ and commercial manufacturing campaigns run at the site. As appropriate responsibilities include:
Knowledge of parenteral filling (vials cartridges syringes) operations lyophilization and visual inspection activities
Lead Process & Technology Transfer teams technical improvement projects and technical process investigations as needed.
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.
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
Lead complex process investigations while servicing as the point of contact to broader organization.
Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site.
Project Management experience in order to facilitate meetings with various stakeholders and communicate to management on the status of programs.
Qualifications:
Bachelors degree in Engineering or relevant scientific/technical discipline with a minimum of 8 years of relevant experience is required OR
Masters degree in Engineering or relevant scientific/technical discipline with a minimum of 6 years of direct experience OR
Ph.D. in Engineering or relevant scientific/technical discipline with a minimum of 4 years of direct experience
Excellent communication and project management skills appropriate for leadership of tech transfer projects
Expertise in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator Lyophilizer Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities
Excels at working in a team environment
Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills
Ability to work independently and lead a large cross-functional group
Knowledge of cGMP FDA/EMA regulations Process Performance Qualification Continued Process Verification
Additional Information
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 $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 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 onto 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.
Required Experience:
Senior IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
