We are seeking a Scientist I / II to join our Analytical Development & Testing department (ADT) here at Recipharm RTP. The level of the position will be based on qualifications and experience.
This position has a minimum 50% expectation of hands on, in the lab testing. Key responsibilities will be:
- High-level individual contributor responsible for analysis of inhalation product samples under minimal supervision.
- Manage & execute method validation, method transfers, and compendial verifications for product characterization.
- Training and mentoring department as SME on instrumentation, method techniques, and software use.
- Author and review protocols, reports, COA’s, SOP’s and other GMP documentation as required at a high quality level.
- Author, revise, and/or review test methods, training materials, and other procedures based on high level of experience & knowledge of technical principles.
- Analyze aberrant data/performance and independently troubleshoot and maintain instrumentation to reduce downtime.
- Participate in and author sections of deviations, laboratory investigations, invalid data events, root cause analyses, change controls, CAPAs, and other Quality System procedures as required.
- Ensuring compliance with site SOP’s, Training, Data Integrity guidelines, and GMP certificate requirements.
- Ensuring department compliance with laboratory maintenance & cleaning, safety procedures and OSHA requirements for material handling.
- Represent the department in audits and customer visits.
Required Qualifications:
- The Scientist I position requires a BS degree in Chemistry (or related Life Science) and 4+ years of relevant experience, an MS degree with 2+ years of relevant experience, or a Ph.D. with 1+ years of relevant experience and academic coursework.
- The Scientist II position requires a BS degree in Chemistry (or related Life Science) and 6+ years of relevant experience, an MS degree with 4+ years of relevant experience, or a Ph.D. with 2+ years of relevant experience and academic coursework.
- 4+ years’ Experience with:
- Method Validation, Method Transfer, and GMP release / stability testing experience utilizing HPLC and Empower 3.
- CRO / CDMO industry including direct customer interaction.
- Writing protocols, reports, COAs, test methods, and other GMP documentation.
- Managing quality discrepancies with investigations, root cause analysis, hypothesis testing, deviations, change controls, CAPAs, etc.
- Direct experience maintaining, troubleshooting, and optimizing LC instrumentation with UV, PDA, ELSD, and/or CAD detector systems.
- Proficiency with the following instrumentation & techniques
- HPLC
- FTIR
- Titrations & Wet Chemistry testing
- Thorough understanding of general laboratory procedures to reliably conduct analyses and operate lab instrumentation.
- Understanding of ICH, FDA, and other regulatory expectations for method validation, transfer and GMP testing.
Preferred Qualifications
- Experience with inhaled dosage forms and devices used for drug delivery.
- Experience with Mass Spectometry
- xperience with method development & optimization
- Experience with managing customer/project timeliness, resources, and budget.
- Advanced experience with Empower 3.
- Understanding and experience with 21 CFR Part 11 requirements for electronic records/signatures, data management, and industry requirements for data integrity.
We offer a competitive compensation and benefits package including:
Full Benefits (Medical, Dental, Vision, Life, Disability)
401(K) with Company Match
Paid Vacation & Sick Time
Dependent Care FSA
Educational reimbursement program
**Relocation assistance is not provided for this position. Candidate must be able to commute daily to the job site**
COVID-19 considerations:
Per local mandate, masks are required on site. Vaccinations strongly recommended for all adults.
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Company Description:Recipharm is a leading CDMO (contract development and manufacturing organization) in the pharmaceutical industry employing 9,000 employees with headquarters in Sweden. One of Recipharm’s nine research and development facilities is in Research Triangle Park, North Carolina, USA. Recipharm Laboratories aspires to be the first-choice strategic partner for inhaled drug development companies worldwide.