Research and Development Associate jobs in Fitchburg, MA

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, Drug Product Development opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Research Associate II will support drug product development activities including formulation screening, process development and optimization by performing cell culture and wet lab experiments, analyzing data, and drafting protocols, SOPs and reports. The Research Associate 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.

Essential Job Responsibilities:

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

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

• Execute protocols [SOPs and batch records] with some guidance and summarize results independently.

• Growing technical knowledge and continued understanding of operations with ability to troubleshoot technical problems.

• Conducts experiments after discussion of the design and strategy with the supervisor.

• Performs literature searches and analysis as needed for drug product development.

• Writes technical reports detailing procedures, outcomes, and observations.

• Maintains accurate record keeping in laboratory notebooks and appropriate databases in a timely manner

• Maintains inventory of reagents and disposables and orders supplies as needed

Quantitative Dimensions:

• The work will focus on drug product development activities including formulation screening and optimization, process development for drug product manufacturing and clinical trial investigation. Successful completion of tasks will facilitate technology transfer from product introduction to manufacturing and lead to the timely initiation of new clinical trials and/or commercial production of drug product.

Organizational Context:

The Research Associate II reports to the Scientist of Drug Product Development and will collaborate with other members of the drug product development team. This individual will also work closely with other functions such as Process and Science Technology, Analytical Development and Manufacturing.

Required:

• BS with 3 years or MS with 0-2 years’ experience in the biotechnology field

• Proficient in aseptic technique, mammalian cell culture, and cell characterization techniques

• Ability to write SOPs, maintain accurate records, analyze data and effectively manage multiple projects

• Knowledge of cell biology and/or product development

• Capable of meticulous GDP/record keeping

• Willingness and ability to learn new skills

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

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

• Ability to collaborate with internal and external partners across multiple scientific disciplines

• Excellent written and oral communication skills

• Ability to work a flexible schedule

Preferred:

• Previous experience with pluripotent stem cells, immune cells and cell-based assays

• Previous GMP experience

• Knowledge of drug product development and tech transfer

• 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, 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