Massachusetts Jobs

Research Associate II, 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 for 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 Research Associate II opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

We are seeking a highly capable, self-motivated Research Associate (RA) to join CMC Operations team. The RA will support drug product development activities including cell culture support, formulation screening, process development, drug product and delivery device testing, and technical transfers both within and outside of the company by performing wet lab experiments, data analysis, and drafting of protocols, SOPs, reports, and clinical training materials. The RA will execute protocols with some guidance and summarize results in an independent manner. This individual will collaborate closely within the team and across functional groups to advance pipeline programs. Additional responsibilities include work with electronic lab notebook systems, including for cell bank inventories.

Essential Job Responsibilities:

• Contributes to drug product process development and technical transfer activities through cell culture, cryopreservation and product characterization studies.

• Utilizes established techniques in cell culture, cell and molecular biology, and immunology to generate data using good documentation practice and in an accurate and reproducible manner.

• Support drug product development activities including formulation screening, process development, container integrity, drug product and delivery device testing, and technical transfers both within and outside of the company by performing wet lab experiments, data analysis, and drafting of protocols, SOPs, reports, and clinical training materials.

• Maintains accurate records and assists other team members with recording and compiling experimental data in a timely manner.

• Shows willingness to learn new protocols, relevant equipment, and related software.

• Summarizes and presents data in both oral and written formats.

Qualifications:

Required:

• BS Degree with 2+ years or MS Degree with 0-2 years of relevant hands-on laboratory experience including aseptic technique and mammalian cell culture.

• Familiarity working with cell-based assay design and execution, as well as drug product development.

• Strong organizational, time management skills, and the ability to maintain accurate and up-to-date records.

• Ability to work effectively both independently and as part of a team.

• Excellent written and oral communication and interpersonal skills.

• Strong work ethic with a passion to learn and work in a fast-paced, dynamic and diverse work environment.

• Ability to troubleshoot and think critically, with careful attention to detail.

• Ability to work a flexible schedule.

Preferred:

• Knowledge of drug product development and tech transfer

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

• Experience drafting surgical training documentation.

• Experience with electronic notebook system for maintaining cell inventories.

• Familiarity with cGMP practices.

Working Environment:

• This position is based in Westborough, MA and will require on-site work.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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-TD

Category CMC Technical Operations

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

EOE including Disability/Protected Veterans