Sr Manufacturing Specialist I, MTO

Biogen•Research Triangle Park, NC

3d•Onsite

About The Position

About this Role In this Sr. Manufacturing Specialist I role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You’ll Do Author manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision. Project management and project execution – lead or participate in projects, facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation. Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met. Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions. This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support. Who You Are: If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives

Requirements

Bachelor’s degree (Life Sciences or Engineering) preferred, with 5 years of transferrable experience.
Associates degree or Bioworks Certificate and 7 years of transferrable experience.
High School Diploma (or Equivalent) and 9 years of transferrable experience.
Prior experience in manufacturing – Drug Product/ Parenteral Filling
Project Management skills
Robust understanding of quality and cGMP principles.
Fundamental knowledge of change control in cGMP environment.

Nice To Haves

Understanding of business processes and roles of cross-functional groups supporting manufacturing operations.
Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
Intermediate to advanced level of technical writing skill.
Ability to interpret manufacturing process design documentation.
Excellent oral and written communication skills.
Experience in Continuous Improvement initiatives

Responsibilities

Author manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision.
Project management and project execution – lead or participate in projects, facilitating timely execution.
Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation.
Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions.

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