QC Lead Analyst, Microbiology

Job Summary

Cellipont Bioservices is growing, and we are looking for a QC Lead Analyst, Microbiology, who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level.

The QC Lead Analyst, Microbiology is responsible for Environmental Monitoring sampling, analyzing, and reporting results, and microbiological testing to support manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

The QC Lead Analyst, Microbiology applies microbiological principles to evaluate contamination risk in aseptic manufacturing, provides scientific input to cross-functional teams, and ensures laboratory testing is executed accurately, on time and in compliance with cGMP. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

The Role

Own, execute, and finalize Environmental Monitoring Performance Qualifications of cleanrooms

Identify objectionable microorganisms and impact to production activities

Implement EU Annex 1 updates to the QC procedures and EM Programs/Policies.

Cross-train into other Quality Control testing areas as required

Compile, trend and interpret large sets of Environmental Monitoring data and prepare technical reports.

Perform routine Environmental Monitoring of Grade A-D Cleanroom environment, including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing facility

Provides input on SOP revisions and assist in the creation and editing of protocols, risk assessment etc.

Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns

Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity

Perform Gown Qualifications and BSC Qualifications

Report and evaluate environmental monitoring excursions and OOS results, applying microbiological principles to support investigations and root-cause assessment

Report and investigate environmental monitoring excursions and OOS results

Effectively communicates results of own work through discussions and documentation with some input from supervisor

Flexibility in following unique campaign requirements that may include off-hour and weekend work

Ability to train fellow analysts on Environmental Monitoring and other microbiological assays

Lead and own various Environmental Monitoring and other QC projects on an as needed basis in collaboration with other departments

Assist in inventory management and cost effectiveness for the department

Other duties as assigned

The Candidate

Bachelor's degree (B.S.) in Biology, Microbiology, Biotechnology or a closely related biological science is required, with 4–5 years of relevant industry experience

Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

Knowledge and ability to apply biological, microbiological and regulatory principles to solve scientific and quality problems

Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision

Experience with viable and non-viable Environment Monitoring collection instruments

Creative individual with outstanding trouble shooting skills

Concentration of aseptic technique and contamination control

Streak plating and microbial identification

Document writing, data interpretation, presentation, statistical analysis and trending a plus

Minimum supervision required on day-to-day activities and accomplished tasks

Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor

Experience working in cGMP Quality Control Laboratory

Experience with Microsoft Office

Strong attention to detail

Familiarity with Good Manufacturing Practices (cGMP's)

Excellent oral and written communication skills.

Must be available to work occasional weekend or holiday support as needed

Position Benefits

Opportunities for career growth within an expanding team

Defined career path and annual performance review & feedback process

Cross-functional exposure to other areas of within the organization

Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members

401K strong employer match

Tuition Reimbursement

Employee Referral Bonuses

Flexible work schedules and PTO and paid holidays

Gain experience in the cutting-edge cell therapy space

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.