Sr. Manager, Manufacturing Upstream

Job Title: Sr. Manager, Manufacturing Upstream
At List Labs, our mission is to harness bacterias potential for a healthier world. We are a premier
contract development and manufacturing organization (CDMO) specializing in bacterial-derived products
for early clinical trials, including live biotherapeutic products from the rapidly growing microbiome field.
Our expertise also includes the production of native and recombinant bacterial proteins and toxins for
research and development.
We offer a dynamic, collaborative environment where innovation thrives, and employees are
empowered to make a meaningful impact.
Position Overview
We are seeking a hands-on and experienced Sr. Manager, Manufacturing Upstream to lead day-to-day
upstream production operations across reagent-grade and cGMP manufacturing of bacterial products
including live biotherapeutic products, bacterial toxins, lipopolysaccharides, and other bacterial
produced native and recombinant proteins. This role is critical to ensuring operational excellence,
scaling manufacturing processes, and developing a high-performing team.
The ideal candidate brings deep expertise in bacterial upstream processing, strong leadership capability,
and a proven track record in cGMP manufacturing environments. This role blends technical depth with
people leadership to drive performance, compliance, and continuous improvement.
Key Responsibilities
? Lead, coach, and develop a team of upstream manufacturing associates, driving performance,
engagement, and career growth.
? Oversee upstream production including fermentation, scale-up, and manufacturing execution
(1L500L).
? Drive technical transfer, process improvements, and operational efficiency initiatives.
? Ensure compliance with cGMP, GxP, and regulatory requirements (US/EU).
? Review and approve manufacturing documentation (batch records, deviations, and quality reports).
? Serve as a subject matter expert (SME) for upstream processes in cross-functional and client-facing
teams.
? Troubleshoot complex technical and operational challenges to maintain production continuity.
? Partner with Quality on deviations, CAPAs, and continuous improvement initiatives.
? Support facility readiness, process validation, and implementation of new equipment and
technologies.
? Monitor KPIs and operational metrics, driving data-informed improvements.
? Promote a strong culture of safety, compliance, accountability, and collaboration.
Qualifications and Experience
? Bachelors degree in Biology, Microbiology, Biochemical Engineering, or related field (advanced
degree preferred).
? 10+ years of cGMP biomanufacturing experience.
? 5+ years of direct leadership experience in a manufacturing environment.
? Strong experience in upstream processing and fermentation technologies.
Knowledge, Skills, and Abilities
? Expertise in bacterial fermentation and scale-up across aerobic and anaerobic organisms.
? Experience with harvest operations (TFF, centrifugation, depth filtration).
? Familiarity with single-use bioreactors and stainless-steel systems.
? Knowledge of cell lysis/homogenization for protein recovery.
? Strong troubleshooting and problem-solving skills in complex manufacturing environments.
? Ability to lead teams, manage priorities, and drive execution across multiple projects.
? Excellent communication and cross-functional collaboration skills.
Physical Requirements
? Ability to wear PPE, including respirators, and work with BSL1BSL3 organisms.
? Capability to lift up to 50 pounds as needed.
? Comfortable working in manufacturing and lab environments with standard physical activity
requirements.
? While performing the duties of this job, the incumbent may be regularly required to stand, sit,
talk, hear, reach, stoop, kneel, and use hands and fingers to operate a computer, keyboard,
telephone, laboratory equipment.
? Adequate vision to read documents, presentations, and data on a computer screen.
Compensation and Benefits
? The anticipated base salary range for this position is $140,000 - $180,000 + sales bonus per year
based on a variety of factors, including but not limited to, internal equity, experience, education,
specialization, skills, abilities, and training relevant to the role.
? The title may be assessed one level lower or higher, accordingly.
? Benefits include medical, vision, dental, vision, and group-term life insurance, 401(k) retirement
plan with a 4% employer match, vacation, and holidays.
? The above salary range represents the Companys good faith and reasonable estimate of the
range of possible compensation at the time of posting.
Why Join Us?
? Be part of a mission-driven organization at the forefront of microbiome-based therapeutics and
biologics manufacturing.
? Lead and scale impactful upstream manufacturing capabilities.
? Work alongside a collaborative, science-driven team.
? Competitive compensation and comprehensive benefits package.
Ready to Make an Impact?
If you are a technical leader passionate about upstream manufacturing and eager to make an impact
withing a mission-driven organization at the forefront of microbiome-based therapeutics, wed love to
hear from you.
Apply Today or reach out directly to learn more!
List Labs HR Email: applicant@listlabs.com