Sr Associate I, Quality Control Microbiology

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 You’ll 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

Bachelor’s 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: $81,000.00-$105,000.00

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 $10,000 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 on  to learn more about our Biogen.

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.