Sr. Manufacturing Specialist II, MFG Tech Ops

Biogen • Durham, NC

114d • $109,000 - $146,000

About The Position

In this Sr. Manufacturing Specialist II 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree