Sr. Research Associate – Assay Transfer

Planet Pharma Group; Tucson (AZ); Vor Ort; USD 44.000 - 52.000; Vollzeit

Zusammenfassung

Planet Pharma seeks an Assay Transfer specialist to drive the transition of reagent products from Development to Manufacturing. You will lead process characterization, scientific research, and strategies to support manufacturability and improve process capability.

The role requires strong wet-lab expertise, IHC/ISH, and experience in regulated settings, with a focus on documentation, quality, and cross‑functional collaboration.

Qualifikationen

• Bachelor’s degree in Science with 6+ years post‑college experience or a Master’s degree with 1+ year of relevant experience.
• Hands‑on experience with wet lab and biological techniques, specifically IHC and ISH.
• Direct experience in a regulated environment, product development, and/or manufacturing operations.
• Proficiency in standard laboratory techniques, literature retrieval, and common software tools.

Aufgaben

• Lead design, execution, and troubleshooting of complex laboratory protocols and scale‑up activities.
• Execute bench experiments, record observations, and perform data analysis.
• Prepare manufacturing documentation and complete transfer activities for new products.
• Champion Quality First Time standards and identify process capability improvements.
• Act as technical resource to troubleshoot problems and implement corrective actions.
• Generate technical reports and present data to project teams and stakeholders.

Kenntnisse

Wet lab techniques

IHC

ISH

Regulated environment experience

Design for Six Sigma

Design for Quality and Manufacturabilt

Documentation & reporting

Ausbildung

Bachelor’s degree in Science

Master’s degree

Tools

Word processing

Spreadsheets

Graphical/presentation apps

Jobbeschreibung

Target Pay Rate: 32-38/hr **salary will be commensurate with experience

SUMMARY

As a member of the Assay Transfer team, you will facilitate the seamless transition of new and existing reagent products from Development to Manufacturing. This role involves initiating, directing, and executing process characterization, scientific research, and manufacturing process strategies to support product manufacturability and improve process capability.

KEY RESPONSIBILITIES & ESSENTIAL DUTIES

• Laboratory Execution & Protocol Design:
• • Lead the design, execution, and troubleshooting of complex laboratory protocols, bench experiments, process characterization, and scale‑up activities with minimal supervision.
• • Execute bench experiments, record meticulous observations, and conduct quantitative data analysis.
• Process Transfer & Quality Standards:
• • Prepare manufacturing documentation and complete transfer activities for new products.
• • Champion “Quality First Time” standards while identifying and implementing process capability improvements in the laboratory environment.
• Problem Solving & Subject Matter Expertise:
• • Serve as a technical resource to troubleshoot complex technical problems, institute corrective actions, and resolve intangible variables.
• • Optimize workflows and identify potential patent or publication opportunities.
• Documentation & Technical Reporting:
• • Generate comprehensive technical reports, summaries, and experimental procedures.
• • Present findings and scientific data clearly to project teams, group meetings, and organizational stakeholders.
• Collaboration & Leadership:
• • Partner actively across organizational boundaries and lead or participate in cross‑functional technical teams (e.g., core teams, failure investigations).
• • Contribute to project planning, provide creative solutions, and mentor or train team members in areas of expertise.

CANDIDATE REQUIREMENTS & QUALIFICATIONS

• Education & Experience:
• • Bachelor’s degree in Science with 6+ years of post‑college relevant experience, OR
  • Master’s degree with 1+ year of relevant experience.
• Technical Expertise:
• • Hands‑on experience with wet lab and biological techniques, specifically IHC (Immunohistochemistry) and ISH (In Situ Hybridization).
• • Direct experience in a regulated environment, product development, and/or manufacturing operations.
• • Proficiency in standard laboratory techniques, scientific literature retrieval, and software tools (word processing, spreadsheets, graphical/presentation applications).
• Methodologies: Ability to apply Design for Six Sigma and Design for Quality and Manufacturability (DQM) principles to optimize processes and solve potential inventions or production issues.
• Candidate Guidelines: Candidates must meet the minimum post‑college experience requirements (6+ years for Bachelor’s). Please do not submit Ph.D. candidates (considered overqualified).