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Job Description
Senior R D Manager Seegene USA Irvine, CA Job Details Full-time Up to $175,000 a year 2 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Referral program Qualifications Biochemistry Master's degree Quality assurance Bachelor's degree Attention to detail Chemistry Design controls Biomedical regulatory compliance Regulatory submissions Senior leadership Full Job Description R D Sr.
Manager Company Overview:
Seegene USA, Inc. is a leading molecular diagnostics company dedicated to advancing healthcare through innovative in vitro diagnostic (IVD) solutions. Our portfolio includes molecular diagnostics leveraging advanced PCR technology. We are committed to delivering high-quality diagnostic tools that improve patient outcomes while upholding the highest standards of regulatory compliance and quality excellence.
Position Summary:
The R D Sr. Manager leads PCR-based IVD product development programs at Seegene USA from feasibility through FDA clearance and transfer to commercial manufacturing. Reporting to the SVP of R D, this position manages the R D team and laboratory environment, represents R D on cross-functional project core teams, is responsible for the analytical components of FDA regulatory submissions, oversees analytical verification, validation, and product qualification activities, and coordinates with Seegene Headquarters on technology transfer and US regulatory strategy.
Roles & Responsibilities:
Leads a significant portion of PCR based IVD product development projects. Represents R D on the project core team, ensuring alignment with Quality, Regulatory, Clinical, Manufacturing, and Commercial functions. Directly manages R D team members including hiring, onboarding, goal setting, performance evaluation, mentoring, and career development. Leads the target gene identification for assays in early feasibility stages of development by reviewing insilico data and literature searches. Leads and reviews oligo screening and optimization studies for highly multiplexed PCR assay development. Leads the development of the assay parameters for assay interpretation. Leads clinical comparator assay selection and instrument/assay qualification; supports clinical trial setup and troubleshooting in partnership with Clinical Affairs. Leads analytical verification and validation studies in support of FDA submissions (Pre-Sub, 510(k), De Novo, EUA), and authors the corresponding analytical sections. Manages the reagent stability program (real-time, accelerated, and in-use) across assays in development and on the market. Leads assay transfer from R D to Manufacturing and QC, including QC release methods and specifications, method transfer, process validation, and deviation resolution. Oversees R D laboratory operations, equipment qualification, inventory, safety, and biological materials handling. Applies Design Control principles per
FDA 21 CFR
Part 820 and
ISO 13485
; supports Design History File maintenance, risk management (FMEA), and change control. Supports internal quality system audits and external regulatory inspections; prepares R D documentation and serves as subject matter expert during audits. Manages R D project budgets, capital purchases, and resource allocation in coordination with leadership. Interfaces with Seegene Headquarters on technology transfer, joint development activities, and alignment on US regulatory strategy. Reviews experimental details required for execution of assigned work for junior scientists. Reviews and approves study results, data interpretations, and technical reports authored by R D staff. Applies knowledge of basic science and employs solid laboratory skills to execute bench experiments Creates, implements, and reviews
SOPs Qualifications:
PhD in microbiology, molecular biology, biochemistry, clinical medical technology, laboratory sciences or other related area and 3+ years' hands on experience with molecular biology or molecular diagnostics assays OR Master's degree in microbiology, molecular biology, biochemistry, clinical medical technology, laboratory sciences or other related areas and 5+ years' hands on experience with molecular biology or molecular diagnostics assays, OR Bachelor's degree in microbiology, molecular biology, biochemistry, clinical medical technology, laboratory sciences or other related areas and 7+ years' hands on experience with molecular biology or molecular diagnostics assays, Minimum 3+ years of direct people management experience (scientists and/or research associates). Experience leading or substantially contributing to FDA 510(k), De Novo, or EUA submissions for IVD products. Working knowledge of Design Controls (FDA 21 CFR Part 820) and
ISO 13485.
Additional Skills:
Excellent verbal and written communication skills. Teamwork, interpersonal and relationship building skills with team members, peers, and senior leaders. Demonstrated excellence in leadership and people management Strong organizational skills with the ability to multi-task. Experience working in a molecular diagnostics company developing IVD products is highly desirable. Demonstrated project management skills with the ability to lead multiple programs in parallel. Experience leading cross-functional teams spanning R D, Quality, Regulatory, Operations, Clinical, and Commercial. Ability to Travel up to 10% of time for conferences, Vendor qualifications, etc.
Job Type:
Full Time -
Salaried Exempt Pay:
Up to $175,000 D.O.E.
Work Location:
In Person (at our facility next to UCI)
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Seegene USA is an equal opportunity employer and values diversity in the workplace. We do not discriminate on the basis of race, color, ethnicity, national origin or ancestry, sex, gender, gender identity, sexual orientation, religion or creed, age, marital or family status, pregnancy or disability, veteran status or military service, genetic information, or any other status protected by applicable federal, state, or local laws.
Pay:
Up to $175,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Referral program Vision insurance Application Question(s): Will you now, or in the future, require sponsorship for employment Visa status (e.g. H-1B Visa status, etc.)? Are you experienced with CAPA investigations?
