Lab Eq Validation /Method Transfer Specialist

Full Time Title: Method Transfer Specialist Location: Onsite Length of Contract: 6 months Position Description:

The Method Transfer Specialist is responsible for the seamless transition of analytical methods between laboratories to the Barceloneta facility. This role ensures that all analytical methods for biotechnological products are robust, validated, and compliant with global regulatory standards. The specialist acts as the technical lead for protocol development, data analysis, and troubleshooting during the transfer lifecycle to ensure no interruption in product supply or quality.

Responsibilities

• Technical: Coordinate analytical method transfer projects for biological products, including HPLC, ELISA, electrophoresis, and cell-based assays.

• Documentation: Author, review, and approve Method Transfer Protocols, Risk Assessments, and Method Transfer Reports (MTRs) in compliance with cllient's Global Quality Standards.

• Gap Analysis: Conduct thorough technical gap analyses and risk assessments (FMEA) between the sending and receiving laboratories to identify potential obstacles.

• Data Analysis: Perform statistical analysis of transfer data to ensure method comparability and adherence to pre-defined acceptance criteria.

• Troubleshooting: Make investigations into deviations or unexpected results during the transfer process; implement Corrective and Preventive Actions (CAPAs).

• Cross-Functional Collaboration: Serve as the primary liaison between Science & Technology (S&T), Quality Control, and Regulatory Affairs to ensure timely project completion.

Qualifications

• Experience: 5+ years of experience in an analytical laboratory within the Biotechnology or Pharmaceutical industry, with at least 2 years specifically focused on Method Transfer or Method Validation.

• Technical Expertise: Deep understanding of analytical techniques for biologics (e.g., protein characterization, purity assays, and potency testing).

• Regulatory Knowledge: Strong knowledge of ICH Q2 (Validation of Analytical Procedures) and global pharmacopeia (USP/EP/JP) requirements.

• Statistical Skills: Proficiency in statistical software (e.g., JMP, Minitab) for data evaluation and comparability studies.

• Language: Fully bilingual in English and Spanish with superior technical writing skills in English.

• Soft Skills: Proven ability to manage multiple projects simultaneously in a fast-paced, deadline-driven environment.

Education

BS, MS, or PhD in Chemistry, Biology, Biochemistry, Biotechnology, or a related Life Sciences discipline.

Equal Opportunity Employer: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.