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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. We are seeking a Metrology Manager to join our Laboratory Operations. Recipharm supports our customers in developing inhaled and nasal products, such as metered dose inhalers, dry powder inhalers, nebulizers, soft mist inhalers, and nasal dosage forms. The many different instruments used are the key to our success, and the uninterrupted access to them is crucial for timely delivery of projects. The metrology manager will be responsible for maintenance and troubleshooting /repair of mainly analytical equipment, keeping instruments in compliance with cGMP requirements and ensure uninterrupted operations. You will collaborate effectively across groups within the organization and provide feedback to senior management on technical needs. This role requires in-depth technical knowledge of analytical instrumentation for pharma applications, excellent communication skills, and strong organizational skills. This is a suitable role for the skilled analyst with a strong technical interest that wishes to move from an analytical to a more technical role, or to a maintenance technician that is ready for a leadership role. Responsibilities
  • Maintains, troubleshoots and repairs analytical instruments, as well as be 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.
  • Plans, organizes, and manages 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.)
  • Ensures appropriate documentation is in place and maintains documentation to comply with guidelines of inspection agencies.
  • May author equipment SOPs and act as an equipment owner.
  • Determines appropriate strategies for use/retirement/purchase of instrumentation in collaboration with senior management
  • Proactively implements solutions to prevent deviations and investigations
  • Develops and manages metrics for instrumentation issues with the aim to reduce interruption
  • Maintain inventory of critical parts for instrumentation
  • Continuously develop competency and expertise in the area of instrumentation
  • Participate in safety risk assessment for new and existing equipment
  • Training personnel on SOP’s and other procedures where applicable
  • Performing laboratory management duties for the laboratory areas, as applicable
  • Overall responsibility of the metrology activities (no direct reports)
  • Other duties as assigned
Qualifications
  • 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 experience of GDP.
  • Knowledge of FDA, USP, and industry requirements for analytical instrumentation qualification and maintenance
  • Must possess direct experience with maintaining HPLC, GC, and other common laboratory instrumentation.
  • Strong IT skills preferred
  • Good verbal and written communication skills. Must be detailed and safety oriented and quality conscious.
  • Excellent organization and time-management skills
  • Experience in statistical analysis and trending of analytical data is advantage
Education and Experience
  • Degrees in Chemistry, Pharmaceutics, Engineering or equivalent preferred with 5+ years’ experience in pharmaceutical Quality Control Chemistry and/or Research & Development.
  • Minimum of AAS degree or equivalent from two-year college program with 7+ years’ experience in pharmaceutical Quality Control Chemistry and/or Research & Development.
  • Experience in troubleshooting, maintenance, and qualification of analytical instrumentation
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.
    About Recipharm Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, pharmaceutical product development and development and manufacturing of medical devices. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s annual turnover is approximately SEK 11 billion. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com