QC Bioassay Specialist Job

Date: Feb 14, 2019

Location: Dublin, IE

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Requisition ID: QUA008419

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.


 


 


MSD Manufacturing Division, MMD, 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.


 


 


Full Description of Position

The QC Bioassay Senior role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic MSD Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. This person will be key in the layout of the lab testing to ensure the process is streamlined and in line with MSD lean methodologies. Additional development opportunities within the micro and chemistry 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 leading talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. The candidate will support the complete analytical lab build.

The facility will utilize the latest innovations in technology and automation and latest in analytical technics. 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 biologics 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 will incorporate micro, chemistry, bioassay, raw materials, stability and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing 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.
• Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
• Strong knowledge and experience of Bioassay methods.
• Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
• Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
• Plan and maintain the laboratory testing schedule to achieve an efficient QC system.
• Maintain good housekeeping and hygiene within the laboratory.
• 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.
• 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 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.
• Responsible for working with contract lab
• Assist in the “operationalising” of the lab with a strong focus on MPS.
• Train and help develop other analyst within the lab.
• 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.


Key Behaviours



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


Collaborate
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 commercial biologic manufacture; inspire, reward and develop to ensure you and those working within you reach their potential; make tough calls when necessary.

Qualifications

Qualifications, Skills & Experience Required



Qualification:
• Degree qualification (Science/Quality/Technical). Master preferred.
• Desirable evidence of Continuous Professional Development.
• Preference Lean Six Sigma



Skills:
• Technical knowledge
• Scientific qualification and relevant experience in pharmaceutical environment
• Leadership sklls.
• Ability to respond to changing priorities.
• Strong organisational skills
• Good verbal and written communication skills
• Excellent 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



Experience:
• 3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs
• Experience in Potency Elisa method
• Working knowledge of QC Systems (EN, LIMS) and Trackwise


 


 


 


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.


 


 


Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms 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, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Housekeeping, Medical, Lean Six Sigma, Biotech, Healthcare, Hospitality, Management, Science

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