Senior Research Associate, Drug Product Development

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 Sr. Research Associate, Drug Product Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Sr. Research Associate will support cutting edge cell therapy drug product development activities including cell culture support, formulation screening, process development, container closure selection and testing, lab-scale fill-finish operations, and drug product testing. The Sr. Research Associate will also be involved in analyzing data, drafting protocols, batch records, SOPs and reports. You will be able to independently execute lab experiments and protocols with some mentorship and have the ability to summarize results independently. This individual will collaborate closely within the DPD team and across functional groups to advance pipeline programs (Analytical Development, Process Science and Technology, Manufacturing Operations, Manufacturing Science and Technology, Quality assurance etc.).

Essential Job Responsibilities:

• Support drug product development and technical transfer activities for cell therapy drug product development.

• Independently contributing to the scientific experiments and continues to take on more responsibility to provide content for various documents, presentations, and reports.

• Motivated research personnel keen to get trained on cell culture, cell and molecular biology, biochemistry, and immunology techniques, to eventually gain expertise to contribute to experiments and generate data.

• Supports the DPD team for equipment research, lab inventory management, vendor identification and sample requests, as applicable.

• Contributes to drug product formulation screening, literature research, process development, and scale up activities as applicable

• Authors technical reports, SOPs and batch records detailing procedures, outcomes, and observations.

• Able to execute protocols, troubleshoot and summarize results independently.

• Maintains accurate record keeping following principles of good documentation practice in laboratory notebooks and appropriate databases in a timely manner.

Quantitative Dimensions:

The work will focus on drug product development including formulation screening, formulation optimizations and process development of the project in clinical trial stage as well as products and processes under development. Successful completion of tasks will lead to the timely technical transfer and initiation of new clinical trials and/or commercial production of drug product.

Organizational Context:

The Sr. Research Associate reports to the Senior Scientist of Drug Product Development and will work closely with a group of drug product development specialists. This individual will also work closely with other functions such as process and science technology, Analytical Development, MS&T, Manufacturing, quality control, quality assurance and translational development.

Qualifications:

Required:

• B.S. degree with 5+ years of laboratory experience or MS with 2+ years

• Ability to work independently, as well as part of a team

• Self-reliant, self-motivated, and highly organized

• Willingness and ability to learn new skills

• Two or more years of experience with one or more of the following: aseptic fill-finish, drug product development of small/large molecules (parenteral), aseptic cell culture technique, technical transfers of drug product, GMP manufacturing.

• Capable of meticulous GDP record keeping

• Knowledge of drug product development

• Excellent communication skills

• Ability to analyze own data and write concise reports

• Ability to work flexible hours

Preferred:

• Previous experience with pluripotent cells, cell culture techniques, cell counting, molecular biology techniques

• Hands-on knowledge of cell biology

• Previous GMP experience

• Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance

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

#LI-LK

Category Research and Development

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans