Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Senior Scientist, MS&T opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
Within AIRM's Manufacturing Science and Technology (MS&T) team, the successful candidate will lead technology transfer process including authoring/reviewing of technology transfer documents, process validation, & techincial training activities. The candidate will work closely within the team and across functional groups to ensure smooth transition of new products and processes from process development or external partners into GMP manufacturing. The candidate is expected to represent MS&T on project teams as technical subject matter expert (SME).
Essential Job Responsibilities:
* Work closely with process development or external partners, manufacturing operations, supply chain, regulatory, and quality teams to ensure efficient technical transfer of manufacturing processes and implement necessary improvement for efficient GMP operations during new product introduction (NPI) into GMP operations.
* Perform all functions during NPI process including authoring and reviewing of technology transfer documents, supporting change controls, GMP batch records &/or SOP development and training of MFG personnel. May provide on-floor technical support during cGMP production.
* Lead cross functional studies to develop plans amd executing studies to meet objectives including troubleshooting and operational improvements of manufacturing process, and development of SOPs, developmental batch records, and technical reports.
* Perform data mining of manufacturing documentation (batch records, deviations, etc.) to assess process performance and identify potential root causes for deviations.
* Be a subject matter expert (SME) for technical issues that occur during GMP operations.
* Overseeing laboratory equipment maintenance and inventory of consumable materials.
* Maintain up to date knowledge both scientifically & technically.
* May be a Project Leader for internal or cross-functional projects.
* May provide guidance and oversee the activities of other lower-level personnel.
* Report directly to Director of Manufacturing Science and Technology (MS&T)
* BS, MS or Ph.D. degree in biology, bioengineering, or related scientific field with relevant laboratory experience of 12+ years for BS, 8+ years for MS, or 5+ years for PhD in a biotechnology, cell therapy or pharmaceutical industry, or stem cell research field.
* Solid understanding of various cell culture platforms including both adherent and suspension cell culture systems.
* Experience with embryonic stem/iPS cell culture and differentiation processes including using cellular and molecular technicques such as qPCR, FACS, immunodetection assays for process/product characterization.
* Proficiency utilizing MS Office products and basic statistical software.
* Detail oriented with strong planning/organizational skills and documentation practices.
* Able to manage priorities and maintain timelines for multiple projects in a fast-pace setting.
* Strong oral, written communication and interpersonal skills.
* Ability to work effectively independently, as well as part of a team.
* willing and capable to learn new knowledge and skills.
* Able to work flexible hours including weekends.
* Significant experience in biotech industry with strong knowledge and direct experience in tech transfer and technical support in a cGMP manufacturing environment.
* Strong knowledge and extensive experience with various cell culture platforms including small- & large-scale cell culture systems, especially in application in human pluripotent stem cell culture and lineage differentiation process.
* Experience in leading and execution of studies, and proficiency in writing study protocols and technical reports, authoring/revising of SOP and batch production records.
* Familiarity with GLP/GMP environment and ability to work under SOPs or with batch becords.
* Strong oral, written communication and interpersonal skills.
* Detail/result-oriented, self-starter, and a great team player.
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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