Lead, Manufacturing (Reagents)
Apton Biosystems
Lead, Manufacturing (Reagents)
Position Summary
We are seeking a hands-on and highly motivated production lead to join our Reagents Manufacturing team. The ideal candidate will provide daily guidance on the production floor, ensuring that reagent manufacturing operations are executed efficiently, safely, and in compliance with SOPs, GMP/ISO standards, and production schedules.
This role serves as a working lead, balancing direct production responsibilities with tasks such as coordinating work assignments, supporting continuous improvement efforts and training operators. In addition, this person should proactively manage and resolve real-time production challenges while ensuring adherence to quality standards, including performing in-process checks, reviewing batch documentation, and supporting deviation investigations and corrective actions.
Key Responsibilities
- Coordinate and lead day-to-day reagent production activities such as scheduling, ensuring adherence to batch records, SOPs, and quality standards.
- Act as the first point of contact for troubleshooting production issues and escalating.
- Train and mentor new and existing team members on procedures, equipment, and safety protocols.
- Monitor team productivity, material usage, and workflow to ensure output goals are met.
- Partner with cross-functional teams such as Quality Assurance, NPI, and Supply Chain to support root cause investigations, process improvements, and inventory accuracy.
- Ensure accurate and timely documentation in production records and ERP systems (e.g., SAP).
- Participate in and support audits, CAPAs, and change control processes.
- Maintain cleanroom compliance, 5S standards, and safety procedures.
Required Qualifications
- High school diploma or equivalent is required.
- 3+ years of experience in GMP or ISO-regulated reagent or pharmaceutical production.
- 1+ year in a lead or informal leadership role.
- Strong understanding of reagent manufacturing processes including formulation, filling, and kitting.
- Experience working in cleanroom environments and familiarity with aseptic techniques.
- Proficiency in reading and executing batch records, work instructions, and material handling logs.
- Strong communication, organizational, and problem-solving skills.
- Ability to work in a fast-paced, collaborative environment with changing priorities.
- Comfortable lifting up to 25 lbs. and standing for extended periods.
- SAP experience or strong background in a related ERP platform.
- Excellent interpersonal, written, and verbal communication skills.
Preferred Experience
- Associate degree or relevant technical certification preferred; Bachelor's degree in life sciences, chemistry, or engineering is a plus.
- Familiarity with MES or electronic batch records.
- Experience with lean manufacturing principles or continuous improvement initiatives.
- Prior experience with single-molecule sequencing or biotech instrumentation products is a plus.
This role is not eligible for visa sponsorship.
This role is required to be 100% onsite.
You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
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Salary Range:
$69,400.00 - $104,000.00
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All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
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