High Salary Endotoxin Rfc Microbiological Program Sr Manager Msat

This role will provide YOU the opportunity to lead key activities to progress YOUR career these responsibilities include some of the following The position comprises an array of activities linked to that lead to the successful execution of replacing the animal derived reagent LAL with rFC in the endotoxin test methodology that is embedded in GSK strategy This includes but is not limited to working with internal and external partners to ensure timely transition to the recombinant systems at all internal GSK sites and at CRO CMO The job owner has a role in Analytical Science supporting Large Molecules Small Molecules and Vaccines divisions including related CMOs The job owner has a role to collect analyse plan and align studies for Endotoxin testing This includes Sample organization incl shipment and potential linked change control for sample management where required Authoring of respective study plans and reports according to GSK requirements The job owner will work with internal and or external laboratories for outsourced endotoxin analyses i e set up adequate study protocols aligned with GSK requirements coordinate the samples collection and shipment to the laboratory received the study test results report and write the GSK final study reports applying GMP and GDP practices including respect of Data Integrity rules This includes CRO contract negotiation to execute the laboratory work incl Budget management The job owner ensures the correct program execution at all impacted internal and external sites by setting and tracking SMART and ambitious objectives in alignment with GSK priorities This includes identification and mitigation of risks throughout the project lifecycle to ensure smooth implementation This includes management of the project budget in compliance and according to GSK standard Further the conduction of required program and project steering and linked documentation minutes and reports are produced in a timely manner and are shared with major stakeholders and archived in line with the Company requirements The job owner builds strategic product roadmaps in MSAT and R D and ensures that lab work is prioritized accordingly regarding method development validation to support timely submission planning This includes oversight laboratory work and interim progress evaluation to identify and mitigate risks throughout the project lifecycle to ensure smooth implementation The job owner provides expertise and supporting the GSK network sites and other Global MSAT functions teams engaged in the execution of recombinant endotoxin testing This expertise is transferred through support training and guidance Basic Qualifications Experience at least 10-16 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field A working experience of at least 10 years in the field of microbiology and endotoxin and pyrogen testing is required Education Scientific and Analytical background with a degree preferably advanced in Microbiology Biology or similar field of study Trained on systems used in GSK e g an advantage Excel other IT skills a MUST SAP GLIM change control electronic laboratory notebook a plus Knowledge of GMP regulated environment and linked analytical methods Knowledge of Biopharmaceuticals production and cGMP regulations guidelines Pharmacopeia is an advantage Pro active and Autonomous worker with a strong focus on execution Ability to prioritize and problem solving mind set Hands on mentality pragmatic thinking Good team player with strong organization and communication skills for managing a vast majority of stakeholders from senior management to operational level Intercultural interaction and exchange with people Problem solving and Prioritization skills Execution coordination skills in validation Proficient in both written and spoken English French is an advantage Preferred Qualifications MSAT or Manufacturing Science and Technology is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general The GSK MSAT team is responsible for ensuring that products are produced safely efficiently and to the highest quality standards Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture These include Patient focus Transparency Respect Integrity along with Courage Accountability Development and Teamwork As GSK focuses on our values and expectations and a culture of innovation performance and trust the successful candidate will demonstrate the following capabilities Agile and distributed decision-making - using evidence and applying judgement to balance pace rigour and risk Managing individual and team performance Committed to delivering high quality results overcoming challenges focusing on what matters execution Implementing change initiatives and leading change Sustaining energy and well-being building resilience in teams Continuously looking for opportunities to learn build skills and share learning both internally and externally Developing people and building a talent pipeline Translating strategy into action - a compelling narrative motivating others setting objectives and delegation Building strong relationships and collaboration managing trusted stakeholder relationships internally and externally Budgeting and forecasting commercial and financial acumen Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose - to unite science technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns - as an organisation where people can thrive We prevent and treat disease with vaccines specialty and general medicines We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas infectious diseases HIV respiratory immunology and oncology Our success absolutely depends on our people While getting ahead of disease together is about our ambition for patients and shareholders it s also about making GSK a place where people can thrive We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be A place where they can be themselves - feeling welcome valued and included Where they can keep growing and look after their wellbeing So if you share our ambition join us at this exciting moment in our journey to get Ahead Together Important notice to Employment businesses Agencies GSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine