Mycoplasma Specialist (P2) Job

Date: Mar 28, 2019

Location: Dublin, IE

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Requisition ID: QUA008423

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The QC Mycoplasma specialist role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the new strategic MSD Biotech Drug Substance facility in Swords. This position will be responsible for qualifying the Mycoplasma Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods. This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with MSD lean principles. Additional development opportunities within the Microbiology/ Mycoplasma lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases.

To maximize the development opportunity, the candidate will be the key talent in analytical Mycoplasma techniques and in current Pharmacopeial methods.

The facility will utilize the latest innovations in technology and automation to ensure that MSD has the best in industry tech enabled laboratory. The candidate will work with a high performing cross functional team of talent sourced from across MSD and the biotechnology industry. Together, the team will build the future of MSD Biotech through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.

The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.

The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.

The full analytical scope of QC will incorporate microbiology, mycoplasma (DNA) analytics, analystical chemistry, bioassay, raw materials, stability and in-process testing. Advanced analytical methods (rapid ID techniques, paperless lab, etc) will allow the successful candidate to work in a innovative and stimulating environment which encourages communication and ideas for the future. The candidate will have responsibilities in analytical transfer and qualification of methods.

Activities within the role

  • The motivation to be an inspiring member of a high performing team.
  • The desire to continuously learn, improve and develop.
  • To develop and support the Mycoplasma laboratory
  • Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
  • Perform and carry out a testing of Mycoplasma / DNA testing for in process and drug substance material as required using QPCR and other rapid DNA techniques in compliance with GMP requirements.
  • To review and schedule mycoplasma testing for a small team of mycoplasma analysts.
  • To integrate and complete all documention on time and be familiar with LIMS.
  • To train and be trained in the use of Rapid microbiology techniques.
  • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • To update SOP’s and write protocols as required.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Reagent preparation and routine equipment maintenance.
  • Maintain good housekeeping and GLP within the laboratory.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Ensure training is current for all job functions performed.
  • Assist in training new QC Analysts on routine PCR amplication and extraction procedures and practices.
  • Order, stock and receive laboratory supplies.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
  • Delivery of area performance to meet or exceed performance or quality goals.
  • Promote and participate in the implementation and maintenance of the relevant safety programmes.
  • Participate and Comply with the MSD Quality Management System requirements.
  • Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools.
  • This position will be on days but may require some flexibility from time to time.

Key Behaviours

Focus on Customers, Including Patients
Focus on delivering value for customers, including patients, by understanding and meeting their needs.

Actively listen and seek to understand of all activities assigned and ensure all improvements and streamlining of such activities is taken into consideration.

Act with Candor and Courage
Speak openly, honestly and with conviction; have the courage to take appropriate risks while ensure laboratory GMP activities are always adhered too.

Make Rapid, Disciplined Decisions
Make timely decisions at the right level with the right data, document decisions and support them once made.

Drive Results
Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results, while supporting others.

Demonstrate Ethics & Integrity
Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.

Build Talent
Build diverse talent with the capabilities necessary to succeed in a commercial biologic manufacturing enviroment; inspire, reward and develop to ensure you and those working within you reach their potential; make tough calls when necessary.

  • Minimum Degree qualification (Science/Quality/Technical).
  • Preference Lean Six Sigma
  • Ability to respond to changing priorities.
  • Strong organisational skills.
  • Good aseptic technique and awareness of contamination control.
  • Good verbal and written communication skills.
  • Troubleshooting and problem-solving skills.
  • Good attention to detail.
  • Ability to think logically and be proactive.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Flexible and self-motivated.
  • 3-5 years industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
  • Experience in compendial testing for Mycoplasma monitoring in clean room environments.
  • Working knowledge of QC Systems (Empower, LIMS, Trending systems.)

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

Job Segment: Microbiology, Biotech, Housekeeping, Medical, Science, Hospitality, Healthcare

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