Sr Manufacturing Specialist , MTO

Position: Sr Manufacturing Specialist I, MTO
Location: Triangle

Sr Manufacturing Specialist I, MTO page is loaded## Sr Manufacturing Specialist I, MTOremote type:
On Campus locations:
Research Triangle Park, NCtime type:
Full time posted on:
Posted Yesterday job requisition :
REQ
22117
** 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

Required Skills:

* 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.

Preferred

Skills:

* 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

Job Level: Professional
** Additional Information
** The base compensation range for this role is: $-$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…