Research Associate, Drug Product DevelopmentPurpose & 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
Required Qualifications - BS with 3+ years or MS with 0-2 years' experience in the biotechnology field
- Proficient in aspetic 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.
Preferred Qualifications - 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
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.
Salary Range$69,790-$99,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
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
- Company fleet vehicle for eligible positions
- Referral bonus program
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