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Astellas Pharma Senior Scientist, MS&T in Westborough, Massachusetts

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.

Purpose:

Within AIRM's Manufacturing Science and Technology (MS&T) team, the successful candidate will lead technology transfer, manufacturing technical support, process validation, & training activities with ability to troubleshoot and solve technical problems. The candidate will work closely within the team and across functional groups to ensure smooth transition of new products and processes from process development into GMP manufacturing. The candidate is expected to establish and define plans to meet objectives.

Essential Job Responsibilities:

  • Work closely with process development, manufacturing operations, supply chain, regulatory, and quality teams to ensure efficient technical transfer of manufacturing processes, process validation and implement necessary improvement for efficient GMP operations

  • Establish and define implementing plans to meet objectives

  • Lead cross functional studies for troubleshooting, and improvements of manufacturing process

  • Provide training of MFG personnel, support GMP batch records development, and may provide on-floor support during cGMP drug production process.

  • Perform data mining of manufacturing documentation (batch records, deviations, CAPA, etc.) to assess process performance and identify root causes for deviations.

  • Be a subject matter expert (SME) for technical issues that occur during GMP operations

  • Responsible for development of SOPs, developmental batch records, and technical reports.

  • Assist in supervising laboratory equipment maintenance and inventory of consumable materials.

  • Maintain up to date knowledge both scientifically & technically.

Quantitative Dimensions:

  • May be a Project Leader for internal or cross-functional projects.

  • May provide mentorship and oversee the activities of other lower-level personnel.

  • Creates a positive work environment promoting partnership, mutual respect, encouraging change, innovation, and accountability at all levels

Organizational Context:

  • Report directly to Associate Director of Manufacturing Science and Technology (MS&T)

Qualifications:

Required:

  • Bachelor's Degree + 12 years' experience, Master's Degree + 8 years' experience, PhD + 5 years' experience in biology, bioengineering, or related scientific field with relevant laboratory experience

  • Experience with process optimization and in process characterization with cellular and molecular techniques such as qPCR, FACS, immunodetection assays.

  • Proven understanding of cell culture platforms including both adherent and suspension cell culture systems

  • Proficiency using MS Office products and statistical software

  • Detail oriented with strong 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 and willing to learn new skills.

  • Able to work flexible hours including weekends

  • Detail- oriented, self-starter, and a great teammate.

Preferred:

  • Knowledge and experience with process development and/or characterization of biologics and/or cell therapy manufacturing process.

  • Proficiency in writing technical and study reports.

  • Familiarity with GLP/GMP environment and ability to work under SOPs or with batch records.

Benefits:

  • 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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Category Research and Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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