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POST DATE 8/25/2016
END DATE 10/24/2016
JOB DESCRIPTIONAlkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
Oversees and leads all Wilmington, Ohio activities related to product programs within technology platform(s) in this leadership positions within Alkermes, Inc. This position will work closely with CMC and Development Team Management and the R&D Integration & Program Management department to establish the overall strategy and key tactical milestones for development and clinical project activities that occur in the Wilmington, OH facility. The Ohio Program Manager will lead, track and report progress on the Ohio teams day-to-day execution on all aspects of the product from development, scale-up, clinical product readiness through commercialization. Product activities are supported through matrixed resources, and the position requires close and open communication with the Wilmington teams, Development Teams and Waltham project team including key functional representatives and department leaders.
* Oversight of product programs, including development and implementation of strategy, and overall delivery to budgets, timelines, and development plans that are established by the CMC and Development Team Management.
* Lead Wilmington, Ohio team to establish and meet key program milestones.
* Track and report Ohio team activities to plan and milestone timelines.
* Provide leadership, guidance, and project management support to product team representatives.
* Ensure efficient communication of program status, potential problems and resolutions to issues.
* Skilled Project Manager
* Exceptional communication skills.
* Broad knowledge and technical skills in drug development, clinical manufacturing and commercialization process.
* Have a strong understanding and in-depth knowledge of oral solid dosage form development, scale up and commercialization.
* Successful track record of delivering projects/programs on schedule and within budget.
* Prior experience with US regulatory submissions, global experience is a plus.
* Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
* Demonstrated ability to deal effectively across multiple functional departments in a matrixed product team structure.
* Demonstrated success in building and running strong, high-performing teams.
* Presentation abilities to technical and management teams
* Proficient in MS Office software programs including Word, Excel, and PowerPoint and MS Project.
Education & Experience:
* BS degree in a relevant scientific discipline, or equivalent
* Minimum of 6 years pharmaceutical industry experience
* Minimum of 2+ years of line supervision and/or product team leadership (project management)
* Prior experience in product scale-up and commercialization of drug product(s)
Personal Attributes Needed:
* Self-starter; highly detail and results-oriented
* Ability to interact readily with personnel across different departments and to engage senior site management to achieve project success
* Fosters collaborative relationships within and across groups through influencing and negotiation skills
* Logical problem solving skills
* Demonstrates ability to create and maintain a highly effective team
* Effectively manage conflict and differences of opinion
Physical Demands and Work Environment:
Travel domestic and international - up to 25%
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.