Microbiologist

Mindlance; Collegeville (PA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading life sciences company is looking for a microbiology support specialist in Collegeville, Pennsylvania. The candidate will ensure that microbiology data meet compendial and quality standards. Key responsibilities include coordinating testing for finished products, reviewing test results, and providing regulatory submission support. Applicants should have a Bachelor's degree in Microbiology/Biology and experience in pharmaceutical microbiological procedures and GMP compliance.

Qualifications

• Bachelor's degree in Microbiology/Biology required.
• Experience in sterile and non-sterile product microbiological procedures.
• Familiarity with GMP requirements.

Responsibilities

• Coordinate microbiology testing to support product release.
• Review microbiological test results for accuracy and quality.
• Maintain training records and adhere to SOPs.

Skills

Microbiology testing

Data analysis

GMP knowledge

Communication

Problem-solving

Education

Bachelors Degree in Microbiology/Biology

Job description

Job Description

Provide microbiology support for pilot plant facilities and project teams to ensure microbiology data meet compendial and quality standards.

Key Responsibilities

• Co-ordinate or perform appropriate microbiology testing to support release of finished products or testing of stability samples for clinical product manufacture.
• Review microbiological test results from in house or contract microbiological testing labs for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.
• Defining or reviewing the microbiological control strategies for drug products (both API and Formulations).
• Provide CMC regulatory submission support with respect to microbiology for milestone studies.
• Maintain partnership with clinical manufacturing and product development teams to provide timely and high quality data and service.
• Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures.
• Maintain training records and familiarity with current SOPs and controlled documents.
• Proactively seek assistance from other scientists to solve problems.
• Works to GMP standards as appropriate.
• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Competencies

• Bachelors Degree in Microbiology/ Biology with pharmaceutical experience in sterile and non-sterile product microbiological procedures, method development, validation and testing of API/drug products.
• General compendial knowledge of the USP Microbiology.
• Experience with GMP requirements for Microbiology laboratory and clinical manufacturing plants.
• Excellent verbal and written communication skills.
• Ability to prioritize and organize tasks.

Additional Information

All your information will be kept confidential according to EEO guidelines.