Research Associate II, Drug Product Development
Astellas Pharma
Summary
The Research Associate II will support drug product development activities including formulation screening, process development and optimization, in-use evaluation, analyzing data. 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.
Job description
Purpose & Scope
The Research Associate II will support drug product development activities including formulation screening, process development and optimization, in-use evaluation, analyzing data. 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.
Role and Responsibilities
- Contributes to drug product process development and technical transfer activities through cell culture, formulation screening and product characterization studies
- Utilizes established techniques in cell culture, cell and molecular biology to generate data in an accurate and reproducible manner
- Execute protocols & batch records with some guidance and summarize results independently
- Growing technical knowledge and continued understanding of operations to start troubleshooting technical problems with guidance from supervisor
- Conducts experiments after discussion of the design and strategy with the supervisor
- Performs literature searches and analysis as needed for drug product development
- Contributes to the writing of 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
Location and Working Environment
- This position is based in Westborough, MA and will require on-site work
- The Research Associate reports to a Scientist within Drug Product Readiness and will collaborate with other members of the drug product development team. This individual will also work closely with other functions such as Process Readiness, Analytical Development, MSAT and Manufacturing
Requirements
- 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 support writing of SOPs, maintain accurate records and analyze data
- Knowledge of cell biology and/or product development
- Capable of meticulous GDP/record keeping
- Willingness and ability to learn new skills and knowledge
- 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 occasionally work a flexible schedule based on experiment needs
- Previous experience with pluripotent stem cells and cell-based assays
- Proficiency with Data analysis software – Graphpad Prism, JMP
- Previous GMP experience
- Knowledge of CMC or drug product development and tech transfer
- Knowledge of GMP, ICH, USP/JP/EU/global compendial, regulations and guidance
Benefits
- Medical, Dental & Vision
- Generous PTO
- 401(k) Matching
- Company Paid Life Insurance
- Annual Corporate Bonus
- Quarterly Sales Incentive
- Long Term Incentive Plan
- Company Fleet Vehicle
- Referral Bonus Program
Company overview
Astellas Pharma Inc. is a leading Japanese multinational pharmaceutical company headquartered in Tokyo, Japan. Founded in April 2005 through the merger of Yamanouchi Pharmaceutical (established 1923) and Fujisawa Pharmaceutical (established 1894), Astellas has grown into a global life sciences company with operations in more than 70 countries worldwide. The company employs approximately 14,500 people globally and generates annual revenues exceeding $12 billion. Astellas is committed to turning innovative science into value for patients through transformative therapies in key therapeutic areas including oncology, ophthalmology, urology, immunology, and women's health. The company's notable products include Xtandi for prostate cancer, Padcev for bladder cancer, Xospata for acute myeloid leukemia, Veozah for menopausal symptoms, and Izervay for geographic atrophy. With a strong focus on research and development, Astellas invests approximately 17% of its sales revenue into pioneering new healthcare solutions for diseases with high unmet medical needs. The company operates multiple research centers in Japan, the United States, and Europe, and has established strategic partnerships and acquisitions to expand its pipeline and capabilities in areas such as gene therapy and immuno-oncology.