drjobs Manager Manufacturing Technical Operations ASO OSD

Manager Manufacturing Technical Operations ASO OSD

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1 Vacancy
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Job Location drjobs

Durham County, NC - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

About This Role

Responsible for supporting the technology transfer process driving continuous improvement and managing/authoring all manufacturing technical instructions associated with the different unit operations (batch production records procedures work instructions etc). This position will collaborate with other MTO (Manufacturing Technical Operations) teams across the network to ensure consistency (as applicable) and partner with Quality Manufacturing Manufacturing Sciences Engineering and other functional groups to ensure accuracy and timeliness of documents.

What Youll Do

  • Plans leads and manages all activities withing scope of Manufacturing Technical Operations. Assigning appropriate resources to tech transfers driving continuous improvement ensuring manufacturing instructions are clear safe and compliant. This position may also manage the batch issuance process/team for manufacturing records and labels and/or the Manufacturing Coordination team for direct operational support.
  • Effectively lead and coach direct reports to meet career goals and business objectives. Addresses human resource development opportunities and challenges. Actively participates in hiring the best talent and works to develop an exceptional workforce.
  • Responsible for supporting deviation CAPA and GCC closures as needed. Supports inspection readiness efforts. Evaluates develops and implements human performance continuous improvements and best practices for the group.
  • Engages in strategic and/or global activities and applies strategies to their department. Participates on a variety of strategy related teams such as CMC crosssite teams global practices teams information technology regulatory submission teams and compliance improvement teams.

Qualifications :

Required Qualifications:

  • Bachelors Degree in Life Sciences or Engineering plus minimum 5 years of experience working in a biotech or pharmaceutical GMP manufacturing environment
  • OR Associates Degree plus minimum 7 years of related experience
  • OR High School Diploma plus minimum 9 years of related experience
  • Understanding of Quality Systems and direct experience with Change Controls CAPAs Investigations
  • Excellent project management skills
  • Must be teamoriented (proactively builds healthy working relationships between their department and other groups)
  • Strong leadership skills and excellent written and oral communication and presentation skills
  • Strong strategic thinking skills having a broad knowledge of GMP operations QA QC Regulatory and/or Materials Management
  • Some understanding of finance/budgeting

Preferred Qualifications:

  • Proven effectiveness in managing employees


Additional Information :

The base salary range for this position is $00 annually. 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 longterm 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 wellbeing; including but not limited to:

  • Medical Dental Vision & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short and LongTerm Disability insurance
  • A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 on to 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 EVerify Employer in the United States.

 


Remote Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

Department / Functional Area

Manufacturing

About Company

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