Biogen · 19 hours ago
Principal Engineer/ Principal MFG Scientist, Mfg Sciences
Triangle, NC
Full-time
Onsite
Senior Level, Lead/Staff
$151K/yr - $208K/yr
6+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Principal Engineer/ Principal Manufacturing Scientist to provide technical expertise for clinical and commercial manufacturing campaigns, focusing on process improvements and technology transfers in their Parenteral Facility Drug Product site.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Lead investigations and act as the point of contact for the Manufacturing Technical Organization
Develop an in-depth training program to enhance process understanding for seasoned manufacturing personnel
Analyze data related to unit operations and establish a platform for trending programs
Manage technical projects that provide value to the RTP Pharma site, ensuring process improvements and transfers
Communicate continuous improvement activities, deviations, technology transfer deliverable schedules, and metrics to management and partner departments
Facilitate meetings with various stakeholders and report program statuses to management through effective project management
Actively pursue and implement technical improvement projects through the global change control process
Interface with regulatory agencies during inspections, presenting technical reports and operational activities
Qualification
Required
Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 10 years of relevant experience is required OR
Masters degree in Engineering or relevant scientific/technical discipline with at minimum 8 years of direct experience OR
Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 6 years of direct experience
In-depth knowledge 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
Ability to work independently and collaboratively in large cross-functional groups
Effective communication and project management skills for leadership in technology transfer projects
Proficiency in analyzing scientific datasets with strong analytical and written skills
Ability to lead and work well in individual and leadership roles
Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification requirements
Preferred
Experience with regulatory inspections and technical report management
Strong background in data analysis for process improvements
Ability to develop and implement training programs for manufacturing personnel
Six Sigma Black Belt Certification is strongly preferred
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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