Director, Sterile Sustained-Release & Solids Product Development

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 .

Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus on biodegradable and non-biodegradable sustained release implants and injectable particulate drug delivery systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.

The essential components of this position are in-depth understanding of pharmaceutical formulation principles, manufacturing process development and tech transfer, global CMC regulatory requirements as well as strong organizational skills to develop sterile sustained release dosage formulations intended for clinical trials and commercialization. Specifically,
• Provide scientific and technical leadership for product development projects. Independently set priorities aligned with department goals and manage time in order to meet the changing demands which accompany the simultaneous pursuit of multiple projects. Experience and understanding of market and patient needs to enable an effective life-cycle management strategy with various product offerings, is essential
• Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
• Represent department at CMC/Project Team meetings and ensures that team develops a strong collaboration within Pharmaceutical Science, Clinical and Commercial Manufacturing groups, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
• Apply current CMC regulatory requirements and guidances to support global registration of new products. Following strong scientific principles as well as established practices such as Quality by Design, this individual will lead the group in ensuring that all output also meets internal requirements as well as all applicable regulatory requirements.
• Develop organizational structure to meet key sustained release product platform needs. Specifically, experience with identifying key personnel to hire, CRO/CMO that specialize in product development, facility and equipment needs as well as setting development strategy with key consideration to worldwide regulatory expectations are highly desired.
• Lead the product development group in developing novel formulations as well as to evaluate and adopt new technologies developed elsewhere to build a strong suite of platforms at AbbVie. Establish external network with key universities and thought leaders to bring the necessary rigor and expertise in-house.
• Exhibit leadership skills that result in good performance and career development of junior staff.
• Have excellent communication (oral and written) and interpersonal skills to be able to effectively communicate scientific conclusions and project topics with key stake holders and senior management

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Qualifications

Education and Experience
• The position requires a Ph.D. in Pharmaceutical Sciences, Chemistry, Pharmaceutical Chemistry, Pharmaceutics, or Chemical Engineering with 10+ years of relevant experience.
• At least 4+ years of management experience including managing a group of scientists in similar roles.
• Proven track record in developing and manufacturing sustained release dosage formulations as evident with approved products, patent applications, etc; experience with global regulations governing drug form product approval with particular knowledge and track record with US/EU regulations; experience developing relationships with leading universities and thought leaders; strong leadership skills, demonstrated ability to lead teams and interface with multi-functional areas as well as senior management
• Experience in dealing with CROs and CMOs that specialize in sustained release product development and manufacture.

Essential Skills and Abilities
• Comprehensive knowledge of product development including experience in developing various product formulations.
• Experience and knowledge to anticipate various technical and regulatory hurdles in developing these products for global registration and commercialization.
• In-depth understanding of the issues and controls for the scale-up of these products as well as a good understanding on the manufacturing equipment, for both pilot scale and commercial scale.
• Excellent interpersonal and leadership skills. Ability to influence and motivate others in achieving desired outcomes and decisions.
• Effective use of communication skills both oral and written

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.