AbbVie

Sr. Manager, Biocompatibility

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Oct 05, 2020
Ref
199492
Required Education
Doctorate/PHD/MD
Position Type
Full time

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Senior Manager, Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of Device R&D. The position will be responsible for cross-functional and cross-site leadership of biocompatibility activities, including strategy, execution, and support of regulatory submissions, project teams, and manufacturing.

YOU ARE more than just a title, YOU ARE...

A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

 

  • Organize, schedule and participate in Biocompatibility Team meetings. Communicate project status to supervisor, project teams, other research managers, and R&D committees as appropriate. Frequent communication is essential and must interface with colleagues in Device Research, Product Development, Regulatory, and Manufacturing.
  • Be responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines for biocompatibility activities across therapeutic areas. Actively be involved in the planning, execution and management of biological risk assessments and studies for the safety and biocompatibility characterization of novel and existing products.
  • Contribute as local SME to the design, execution and interpretation of preclinical safety and biocompatibility evaluation strategies and programs according to relevant regulatory requirements; including biological risk assessments and execution of required studies.
  • Participate on Product Development Sub Teams as a Biocompatibility representative.
  • Lead and support the authoring and/or review of documents as required for regulatory registration/submission, regulatory compliance and support of product marketing. Also, author/review documents for internal change control processes in coordination with project teams/manufacturing, as needed.
  • Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.


#LI-PD1

Qualifications

You Bring

 

 

  • Ph.D. and 4+ years of industry experience, Master's degree and 6+ years of industry experience, or Bachelor's degree and at least 8 years of experience. Degree in a related scientific or engineering discipline (cell biology, molecular biology, pharmacology, immunology, bioengineering or similar).
  • Str ong team leadership skills with demonstrated abilities in biocompatibility related activities.
  • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in conducting R&D projects.
  • Experience and working knowledge of medical device, drug and/or biologics and combination product regulations, including ISO 10993.
  • Experience conducting and/or managing outsourced GLP studies.
  • Previous experience with hyaluronic acid, silicone, or tissue-based biomaterials.
  • Strong familiarity with the product development process for medical devices or biologics.
  • Technical report writing proficiency in support of regulatory submissions.
  • Creativity, strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to details.
  • Ability to train junior staff members

 


In this role, we're looking for a leader who will :

 

 

  • Act as an Owner
  • Be Excellence Focused


Act as an Influencer

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.