Job Title: Microbiologist - QC Specialist II Sterility Assurance

Job Description

The incumbent is responsible for assisting in the development and implementation of all microbial contamination control processes/procedures for the company’s clinical and commercial programs at two manufacturing sites. This role will effectively collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. The incumbent will have substantial experience leading QC sterility assurance program(s) in a Pharmaceutical or Biotechnology environment.

Responsibilities

• Assist with the development of sterility assurance principles at the site in the areas of aseptic processing and contamination control.
• Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies, and microbial risk assessments.
• Assist with the design of the contamination control strategy.
• Develop microbial contamination/Cross contamination risk assessments (HACCP/FMEA) and update the assessments as needed based on changes to the program.
• Perform gap/risk assessments EM programs in response to regulatory updates.
• Develop EMPQ strategy and provide oversight of the EM testing program for regulatory compliance.
• Perform EM and Utility trending reports within deadlines, for the 2 sites in PA.
• Support the APV strategy and lead the microbiology-related investigations for APV.
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
• Lead the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs). This includes procurement, budgeting, and induction process.
• Assist with alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures, and compendial/regulatory requirements across sites.
• Participate in facility design and modification, cleaning, and sanitization program.
• Participate as microbiology SME in inspections for Safety Assays and Contamination Control Programs.
• Assist with troubleshooting contamination-related issues occurring in internal and external manufacturing sites.
• Author microbiology trend deviations and help troubleshoot Microbiology safety assays related LIR, OOS, and CAPA records.
• Initiate change controls associated with safety assays validation/verification or major EM program revisions.
• Update EM trackers and regularly communicate to senior levels of management for issues related to contamination control.
• Assist with continuous improvement and implementing best practices (ensuring understanding/compliance with SA related regulations and guidance).
• Perform regular GEMBA style assessments of the aseptic process on-site to assess compliance of operations including identification of deficiencies and provide real-time coaching to aseptic staff.
• Perform routine audits of the manufacturing areas.
• Author new and revised procedures, protocols, and reports for EM program/Safety Assays.
• Provide oversight for the microbiology personnel during safety assay validation/verification execution and compile all the data.
• Evaluate technical data and write technical documents.
• Apply advanced data integrity knowledge and practices.
• Use intermediate understanding of statistics, control charts, action, and alert limits. Perform statistical analysis of the Alert/Action levels for EM/Utility programs and update procedures as needed.
• Possess advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques.
• Perform other microbiology-related studies related to media incubation, feasibility studies for sterility or mycoplasma.
• Act as SME on 2-3 of the Rapid Safety assays (Sterility via BacT, Endotoxin via LAL, Mycoplasma via BioFire and/or qPCR).

Essential Skills

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum four to five (4-5) years of experience in the pharmaceutical industry within a Quality Control Sterility Assurance role or Microbiology role.
• Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP, and JP monographs for microbiology.
• Experience with microbiological concepts and aseptic behaviors, media fills, environmental monitoring.
• Hands-on experience running or validating microbiology rapid safety methods (Sterility via BacT, Endotoxin via LAL, Mycoplasma via BioFire and/or qPCR). Must be a Subject Matter Expert in 2 of the 3.
• Experience with microbiological risk assessments, trending, protocol and report generation.
• Extremely detail-oriented with strong analytical, written, and verbal communication skills.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.

Additional Skills & Qualifications

• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action, and alert limits.
• Ability to perform statistical analysis of the Alert/Action levels for EM/Utility programs and update procedures as needed.
• Advanced knowledge of microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques.
• Ability to evaluate technical data and write technical documents.

Work Environment

Primarily in the lab - must be fully gowned when in the lab.

Pay and Benefits

The pay range for this position is $100000.00 - $110000.00/yr.

PPO benefit plan including flexible spend account, HSA, vision and dental. 401K with employer match, 3 weeks paid vacation and company paid holidays and mandated sick leave.

Workplace Type

This is a fully onsite position in Philadelphia,PA.

Application Deadline

This position is anticipated to close on Mar 11, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $100,000 - $110,000