Senior Manager | Biocompatibility | 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.
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 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.
- Organize, schedule, and participate in Biocompatibility Team meetings. Communicate project status to the 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 in 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.
- 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).
- Strong 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 the 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 detail.
- 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.
Senior Manager | Biocompatibility | AbbVie
To apply for this job please visit www.biospace.com.