Sr Associate I, Quality Control Microbiology

Biogen

Job Location:

Durham County, NC - USA

Monthly Salary: $ 81000 - 105000

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM) with some occasional support required outside of those hours.

About This Role

We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance EM/UM and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned.

What Youll Do

Review test data in LIMS
Prepare quarterly EM/UM reports
Supports testing for all qualification and study directed testing
Troubleshoot complex assays
Perform microbiology testing (e.g. Bioburden Endotoxin plate reading and microbial identification) following standard procedures
Conduct routine Environmental Monitoring (viable and non-viable) in controlled manufacturing areas
Collect and process utility and compressed gas samples
Comply with SOPs and controlled documents under minimal supervision
Maintain laboratory cleanliness equipment readiness and inventory
Perform investigations (i.e. laboratory and deviations)
Follow site safety and contamination control policies
Work overtime as required by business needs
Perform other assigned duties

Who You Are

Someone who demonstrates strong attention to detail and analytical skills along with a solid commitment to maintaining data integrity and quality
You possess a collaborative approach and work effectively across manufacturing and facilities teams

Required Skills

Bachelors in Microbiology Biology or related field
Minimum 4 years experience in pharmaceutical microbiology and GMP-regulated manufacturing
LIMS experience including using electronic notebooks
Demonstrated knowledge of microbiological assays (bioburden endotoxin environmental monitoring) aseptic techniques and general laboratory techniques
Experience with document control including reviewing and editing technical documents
Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
Able to follow procedures and complete technical tasks
Can meet cleanroom and aseptic gowning requirements
Physically able to stand long periods bend move carts and lift 25 lbs
Strong written and verbal communication skills along with proficiency in Microsoft Word and Excel
Excellent organizational skills with the ability to prioritize follow through on tasks and meet deadlines

Preferred Skills

Advanced knowledge of Microbiology testing and Microbiology theory
Prior experience in utilities monitoring including gas monitoring
Prior training experience including classroom training
Proficient in using LIMS systems Veeva Kneat and Microsoft software
Knowledgeable in GMP GLP and GDP requirements
Advanced knowledge of all compendial test methods (Bioburden Endotoxin Sterility testing)
LEAN lab and Six Sigma training and/or certification
Advanced experience with microbial ID systems ability to troubleshoot complex equipment and instrumentation (MALDI MicroSeq)
Experience performing EM/UM excursion investigations

Job Level: Professional

Additional Information

The base compensation range for this role is: $81000.00-$105000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:

Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.

Required Experience:

Senior IC

Schedule: This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM) with some occasional support required outside of those hours.About This RoleWe are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of ...