Metrologist

**_Recipharm Laboratories officially became Bespak as of 4/1/2024._**

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Bespak is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medications, including medical devices such as pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.

Our research and development facility in Research Triangle Park, NC, USA is seeking a **Metrologist **to join us in our operations department. The metrologist will support our scientists and chemists that work on a number of different projects for our clients which include small to mid-size pharma companies with focus on rare diseases to give patients with unmet medical needs better treatment options. This keeps us motivated and gives us the opportunity to make a difference and work on many different exciting, inhaled drug projects. **This position is onsite only.**

**Key technical requirements**:

- Maintain, troubleshoot, and repair analytical instruments. Responsible for scheduling and completing equipment calibration and qualification activities.
- Review completed calibration PMs to ensure that work was completed accurately, and results are within stated tolerance limits.
- Plan, organize, and manage preventative maintenance of laboratory equipment.
- Support junior analysts with troubleshooting of assay related issues in relation to instrument issues (i.e. low counts, irregular pressure traces, retention times, reagents, etc.).
- Determine appropriate strategies for purchase/use/retirement of instrumentation in collaboration with senior management.
- Support new equipment/instrument on-boarding and qualification.
- Proactively implement solutions to prevent deviations and investigations and increase instrument reliability.
- Develop and manage metrics for instrumentation issues with the aim to reduce interruptions to on-going operations.
- Maintain inventory of critical parts for instrumentation.
- Continuously develop competency and expertise in the area of instrumentation.
- Author equipment SOPs and act as an equipment owner, as required.
- Train personnel on SOPs and other procedures where applicable.
- Ensure appropriate equipment/instrument documentation is in place and maintain documentation to comply with the guidelines of relevant inspection agencies (e.g. FDA).
- Assume overall responsibility of metrology activities.
- Supervise and/or train others to support metrology activities.
- Other duties as assigned.

**Required Qualifications**:

- BS degree in chemistry, engineering, or a related technical field and 4+ years of relevant experience.
- Knowledge of analytical chemistry instrumentation theory and operation with demonstrated experience of troubleshooting and resolving common instrumentation hardware and software issues.
- Experience with cGMP documentation and quality systems. Hands-on GDP experience.
- Knowledge of FDA, USP, and industry requirements for analytical instrumentation qualification, calibration, and maintenance.
- Must possess direct experience with maintaining HPLC, GC, and other common laboratory instrumentation.
- Exceptional verbal and written communication skills. Must be detailed, safety oriented, and quality conscious.
- Excellent organization and time-management skills. Experience collaborating cross-functionally and training others.
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**Preferred Qualifications**:

- Experience with inhaled dosage forms and devices used for drug delivery.
- Strong IT skills preferred.
- Experience in statistical analysis and trending of analytical data.
- A continuous improvement mindset and the ability to design and implement new processes to increase equipment/instrument reliability.

**Physical Requirements**:
The **Metrologist** must possess the ability to stand and/or walk for up to 8 hours a day and carry up to 25 pounds. This position involves repetitive motion of the arm, wrist, hand, and fingers with the ability to feel and handle work materials for up to 8 hours per day. The position also requires the ability to carry out tasks involving extensive reaching, crouching, and bending. Day to day tasks may involve handling of and the ability to identify hazardous chemicals and materials.

**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, & Parental

Dependent Care FSA

Educational reimbursement program

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COVID-19 considerations:_**
**_Vaccinations strongly recommended for all adults._