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Director, CMC Process Development

Shire Pharmaceuticals Group

Lexington, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
CMC, Director, Process Development,

Job Description

Primary Duties: This leader is responsible for leading development CMC teams, providing technical directions in process development, and supervising a group of process engineers, scientists and specialists. Applies QbD principles and scientific knowledge to develop efficient and robust upstream manufacturing processes and establish product and process knowledge. Accountable for timely completion and successful transfer of the processes to either internal or external manufacturing partners. In addition, this leader will contribute to establishing the infrastructure and business processes in support of process development from Discovery through commercial launch. Responsibilities: 10% * Manage staff o Anticipate resource requirements, delegate appropriately, and assure reports are productive and work is prioritized and focused o Foster teamwork and drive project/process improvements. o Motivate and support the career development and expanding technical expertise o Communicate company policies/goals/strategies/business results. 50% * Lead dCMC team and accountable for the team performance: o Represent CMC in Early Development Team or Global Development Team o Develop and implement product specific strategies which are aligned with program and Franchise strategies o Execute CMC goals by ensuring cross functional alignment o Deliver robust and efficient DS/DP processes and Analytical methods by applying QbD principles o Deliver clinical supply and necessary characterization to support clinical trial. o Oversee tech transfer o Establish product knowledge o Provide technical leadership and report progress update in various governance committee and functional/program decision making bodies 30% * Provide technical guidance to development programs within his/her functional expertise o Guide staff in phase appropriate process development and characterization. o Ensure application of sound scientific and engineering methodology to process development. o Provide technical guidance in planning, designing and conducting experiments, analyzing data and documenting results towards process development. o Author or approve written study proposals, development reports, ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support development and filing. o Author or approve CMC sections of regulatory filing documents and response to regulatory questions. o Maintain group awareness of relevant scientific literature and industry new trends. Lead new technology evaluation. o Identify innovative solutions that maximize IP protection o Presents at external conferences and symposiums. 10% * Participate in management of the department in terms of budgeting, resource planning, project management, business process design and infrastructure improvements.


Education and Experience Requirements: * Ph.D. : 10 years * MS: 15 years * BS: 15 years Recognized expert by peers both within and outside the company in process development, optimization, scale-up, tech transfer; and manufacturing support. Preferred qualification: Ph.D. in engineering or biological sciences with experiences in process development, tech transfer and CMO management. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

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