Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. www.piramalpharmasolutions.com

The QC Microbiologist Under minimal direction from the manager, performs raw material testing, finished product testing, stability testing, water testing, media preparation, growth promotion of media, antibiotic microbial assay testing, microbial identification, method development testing, suitability testing, antimicrobial effectiveness testing, and other microbial testing as needed. Furthermore, auditing of microbial testing including, but not limited to, water testing, growth promotion of media, and environmental monitoring is executed as necessary. Work is completed with an overall quality and efficiency. Writes, updates, and evaluates new test methods and procedures. Attends team meetings and coordinates projects within the laboratory.

Responsibilities

• Routine Microbial Examination Testing (raw materials, finished products, stabilities)
• Routine water testing, media preparation, growth promotion of media, environmental monitoring, and identification of unknown microorganisms
• Method development testing, suitability testing, antimicrobial effectiveness testing, antibiotic assay testing and other microbial testing as needed
• Auditing of testing (e.g. water, growth promotion, environmental monitoring)
• Training of analysts / technicians
• Perform routine testing to support other groups
• Assist in administrative functions
• Follows Environmental, Health and Safety policies and procedures. Performs other duties as assigned or as business needs require.

Education/Experience

• Bachelor's degree in microbiology, biology, or other related life science
• Minimum 5 years related pharmaceutical microbiology experience
• Advanced degree in scientific field with minimum 3 years related experience
• Experience in training of other analysts in laboratory techniques preferred

Specialized Knowledge Required

• Working knowledge of aseptic technique, microbial examination methods, antibiotic microbial assay, microbial identification and proficiency in many of these techniques.
• Excellent knowledge of FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory.
• Excellent computer skills including MS Office and LIMS.

Functional Knowledge

• Excellent organizational skills and attention to detail
• Excellent at multitasking, handling multiple projects at one time, and changing priorities based on business needs
• Self-driven and motivated
• Problem solving skills
• Excellent interpersonal and communication skills
• Time management

Physical Requirements

• Lift/move up to 10 lbs. and occasionally 25 lbs.
• Individual may be required to handle hazardous and non-hazardous materials. Individual may be required to wear Personal Protective Equipment.
• Not allergic to chemicals or bio-substances found in the laboratory or production facilities.
• Able to work overtime, weekends when required

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Sellersville, PA 18960: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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