Scientist- Drug Product Dev
* This position will provide technical support for the pharmaceutical development of Shire's pipeline products with a focus on development activities for Shire's enzyme replacement therapies for rare diseases. The responsibilities include preformulation, biophysical characterization, formulation screening, and in-use simulation studies. This position will develop scalable and robust formulation processes for drug substance and drug product throughout their product lifecycle.
* The position is responsible for characterization of the product and the drug product manufacturing process. This individual will serve as the subject matter expert for biologics drug product manufacture and stability. In addition, the position will be responsible for executing assessments to evaluate suitability (e.g., compatibility, extractables and leachables) of materials used in drug product manufacture and administration, as well as conduct studies to mitigate any identified risks for biologics drug products.
* The position will work closely with groups in Process Development, Research, Clinical Operations, Quality, and Regulatory as well as external research/contract organizations, and participate in technology transfer, process development, and/or CMC teams representing Drug Product Development.
* 70%: Author protocols, execute laboratory studies, and write reports for pharmaceutical development of Shire's pipeline products.
* 10%: Author/review development documents and support regulatory submissions and responses.
* 15%: Represent DCPD within cross functional project teams (process development, tech transfer, and/or CMC teams.
* 5%: Design in-use studies to support administration of drug product in the clinical setting.
Education & Experience Requirements:
* Advanced degree in biology, chemistry, or related science
* Minimum of 4 years of relevant experience in pharmaceutical development and drug product manufacturing
* Expertise in protein pre-formulation and formulation development, lyophilization, and strong analytical and biophysical characterization skills
* Knowledge of global GMP regulations and guidance documents
* Experience with statistical data analysis
Key Skills and Competencies:
* Excellent scientific knowledge of biophysical (CD, FTIR, fluorescence, etc) and analytical techniques (SE-HPLC, SDS-PAGE, MFI, etc)
* Good knowledge and experience with applying Quality by Design principles and statistical analysis tools for evaluation of drug substance and drug product stability.
* Must be well-organized and self-motivated, and possess an independent work style.
* Ability to perform effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
* Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside Shire.
* Excellent oral and written communication skills including the ability to deliver good presentations and well written technical documents.
Other Requirements: * Some domestic and international travel may be necessary
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.
Please apply at: Application URL: http://www.aplitrak.com/?adid=YWxlYXRvbi40MDI0My4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ