Scientist I/II; Analytical Development, Drug Product Job in Lexington, Massachusetts US
Position Summary:
In this role the analytical development chemist is responsible for supporting the analytical activities related to development stage clinical programs. The analytical chemist will provide focused analytical support and technical guidance to internal and external formulation teams developing drug products for oral, inhalation, and parenteral routes of administration. This position will also support pre-formulation activities, dosing solution analysis, and technical guidance as well as analytical life cycle support to late stage clinical and commercial programs.
Key Responsibilities:
- Developing analytical test methods to support in-process control and release testing of clinical trial materials.
- Provide internal analytical testing support to the RD drug product development group.
- Coordinate method development, GMP validation and testing performed at external CMO and CRO facilities.
- Provide technical guidance to CMO and CRO's to resolve analytical issues during manufacturing campaigns.
- Author and review certificates of testing, analytical methods, protocols and reports.
- Generate batch analysis data tables for intermediates and drug products.
- Represent the analytical function on cross functional teams related to the development and manufacture of clinical phase drug products
Minimum Basic Qualifications:
- Bachelors degree with a minimum of 8 years industry related experience or Ph.D with a minimum of 3 years industry related experience
- Expertise in dissolution method development and dissolution evaluations including comparative dissolution to support drug product development activities
- Expertise in HPLC analysis, method development and trouble shooting
- Experience supporting analytical activities related to drug product
- Strong analytical troubleshooting skills
- Demonstrated ability to analyze and interpret data
- Strong understanding of industry guidance documents (ICH, USP, BP, EP, JP, FDA)
Preferred Qualifications and Experience:
- Previous experience working in GMP or GLP Laboratory setting
- Experience supporting analytical testing of oral and inhalation drug products
- Proficient using Waters Empower software
- Experience with LC/MS analysis
- Experience managing CRO activities
Competencies:
- Aptitude to compile, analyze, and present data in a concise manner.
- Capability to work on multiple projects and meet deliverable timelines.
- Proven ability to drive issues to closure and get the job done in ways that are professional and are reflective of the Cubist code of conduct.
- Demonstrate genuine desire and demonstrate an effectiveness to work co-operatively with others in a team environment towards the achievement of the teams and organizations goals.
- Ability to work independently and utilize effective planning to facilitate individual goal achievement.
- Effective interpersonal skills.
- Demonstrate the ability to communicate clearly, concisely, and effectively to express information in both written and oral context.
Work Environment:
- Office/Laboratory
Physical Demands:
- Occasional travel required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
