Associate Scientist, Pharmaceutical Analysis-Microbiology

CHEManager International; Exton (PA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401(k) plan

Disability insurance

Life insurance

Job summary

Frontage Laboratories Inc. is seeking an Analytical Chemistry-CMC professional in Exton, PA to perform routine and non-routine microbiology analyses and support product development.

The role involves method development/validation, cGMP documentation, instrument qualification, and cross-functional collaboration to meet delivery timelines.

Qualifications

• B.S. in Biology or related discipline with 1-3 years relevant experience in pharmaceutical or related industry (CRO experience is a plus).
• Experience in pharmaceutical product and facility testing (MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET).
• Experience working in a BSL2 laboratory is a plus.
• Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams.

Responsibilities

• Performs method development and validation under supervision.
• Prepares study protocols, reports, investigation reports, and generates cGMP documents as needed.
• Performs quality checks of data, laboratory notebooks, and other scientific documentation as required.
• Maintains qualification and compliance of instruments, and conducts technical and equipment troubleshooting as needed.
• Reports and resolves any unexpected issues under supervision.
• Complies with all relevant cGMP regulatory requirements while carrying out assigned studies.
• Collaborates with team members to meet timelines for drug product delivery.
• Identifies opportunities for improvement in quality of services, and works with the team to implement.

Skills

Biology background

Lab skills

Communication skills

Education

B.S. in Biology or related field

Tools

BSL2 lab experience

cGMP knowledge

Environmental Monitoring

Job description

Frontage Laboratories

Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Full-time
Exton, PA

Frontage Laboratories

Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Analytical Chemistry-CMC

We specialize in analytical services and method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing.

Position Summary

Performs routine and non-routine microbiology sample analysis (specifically, MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, and AET) and a variety of tasks to support product development, ensuring agreed timelines.

Responsibilities

• Performs method development and validation under supervision.
• Prepares study protocols, reports, investigation reports, and generates cGMP documents as needed.
• Performs quality checks of data, laboratory notebooks, and other scientific documentation as required.
• Maintains qualification and compliance of instruments, and conducts technical and equipment troubleshooting as needed.
• Reports and resolves any unexpected issues under supervision.
• Complies with all relevant cGMP regulatory requirements while carrying out assigned studies.
• Collaborates with team members (Analytical Scientists, Quality Assurance, Material Coordinators, and Manufacturing Technicians) to meet timelines for drug product delivery.
• Identifies opportunities for improvement in quality of services, and works with the team to implement.

Requirements

• B.S. in Biology or related discipline with 1-3 years relevant experience in pharmaceutical or related industry (CRO experience is a plus).
• Experience in pharmaceutical product and facility testing (MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET).
• Experience working in a BSL2 laboratory is a plus.
• Capable of setting priorities based in a fast-paced, changing environment.
• Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams.

Salary And Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.