Sr. Director, Drug Development

Location: 

Dublin, IE Gaithersburg, MD, US, 20879

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I.    JOB SUMMARY 

The Senior Director, Drug Development will lead drug development/CMC activities for CNS & Devices R&D and will be responsible for programs from proof-of-concept feasibility through commercial registration.
The future portfolio could include a broad array of drug products, medical devices and combination products including drug delivery devices for sterile injection, wearable, and nasal spray products as well as diagnostic devices for detecting public health threats. 
They will be required to be proficient in a range of technologies from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, parenteral injectable, as well as novel combination product concepts.   
They will manage and direct the technical activities of internal drug development staff in addition to building and managing our network of external collaborators.  
They will have strong leadership skills and a track record of drug/combination product development that they can use to develop and mentor the internal drug development staff. 
They will be a key member of the CNS & Devices R&D leadership team.

II.    ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Build and lead a highly effective internal drug development team – hiring & training of employees, planning assigning & directing work, appraising performances, rewarding and disciplining employees, addressing grievances and resolving problems, developing sound technical and decision-making skills, and empower team members through delegation and collaboration.
•    Develop, set and communicate sustainable targets and goals for direct reports/teams. 
•    Create a supportive work climate that enable staff members to develop professionally, values diversity and open communication, promotes teamwork and collaboration, and stresses quality, safety, customer satisfaction and profitability/cost effectiveness.
•    Initiate development programs and be the lead on specific projects. 
•    Specify the technical requirements for the drug development program, including performance criteria, materials, analytical methods, test protocols, packaging (clinical and commercial) and manufacturing methods.
•    Manage ongoing technical programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt.
•    Prepare, in conjunction with Regulatory Affairs, the appropriate sections of regulatory filings for the products that they manage.
•    Work closely with the device engineering, combination product and Tech ops teams to develop products with a focus on transferring the formulation process to ensure reliability, manufacturability and commercial longevity. 
•    Enhance internal processes, implementing QbD best practices and develop innovations for continuous improvement
•    Create intellectual property covering drug/combination products. 
•    Work closely with business development to identify market opportunities for the device platform technologies
•    Work closely with the Grants & Contracts team to respond to RFPs and win external funding

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    PhD or MS in Pharmacy, Chemistry, Chemical or Materials Engineering (or a related science discipline) with a minimum of 10 years+ experience in pharmaceutical development.
•    Direct experience of pharmaceutical development, QbD and target product profiling, drug delivery of sterile products and drug-device combination products preferable.
•    Broad exposure to established and novel drug delivery technologies is preferred.
•    Experience in development of solid dosage forms, controlled release formulations, long acting injectables, implantable and wearables is desired.
•    Knowledge of drug substance manufacture and analytical chemistry is also preferred.
•    Direct experience with generating CMC documentation for regulatory filings for drug and drug-device combination products. 
•    Proven project management and trouble-shooting skills for technical programs.
•    Proven leadership (on site and remote) of a technical team, including performance management.
•    Proven ability to direct external development external CMO/CDMOs to project completion under rigid timelines.
•    A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
•    Excellent organizational ability and working well in a fast-paced, team-oriented, collaborative way is required. 
•    Excellent communication skills and strong interpersonal skills.
•    Highly organized, with exceptional time management and prioritization
•    Critical thinking evaluation of process problems
•    Strong work ethic 
•    Flexibility to travel on company business when required.

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.