Job DescriptionA new opportunity has arisen for a Senior Specialist to join the Large Molecule Technical Operation Site Support team (LMTO SS). Our team is composed of scientists and engineers who provide skills and expertise to all the Large Molecule manufacturing sites (both internal and external manufacturing) within our Company's Manufacturing Division network. The organization routinely supports the manufacturing facilities in activities such as performing technology transfer, authoring site-based documentation, leading manufacturing investigations and trend evaluations, developing and introducing process enhancements, and providing project leadership. Our goal is to continuously deliver outstanding value to our patients through ensuring technical excellence and robust worldwide supply of our companies’ products.In addition to these areas, our team is building additional capabilities to strengthen connections between site and global teams, make problems visible and improve speed of issue resolution. We are working to establish systems and processes that enable sharing of best practices / lessons learned and proactive / standardized approach to problem solving. Our goal is to ensure that the technical capabilities for all manufacturing operations are ready, continuously improved and in position for right first-time performance.Given the diverse roles that will be played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm, and broad technical knowledge base across multiple different areas. This is a unique opportunity to gain experience across a broad range our business working across drug substance, drug product, internal and external manufacturing for both biologics and vaccine manufacturing modalities.The incumbent will report directly to a technical lead in US or EU region and will support the large molecule business within and outside their own region based on business needs. The position will be located at one of our company's sites and will involve primarily working from a home site but with flexibility to work virtually. The ideal candidate is required to be available to travel to sites within North America and / or Europe, at approximately 50%.Job Functions:
Provision of direct support to drug substance or drug product manufacturing sites
Strategic project leadership for multi-site technical or continuous improvement initiatives
Supporting and leading technology transfer activities at our manufacturing nodes
Facilitation and leadership of quality risk assessments and after-action reviews
Leading complex and/or multi-site investigations
Ensuring best practices are documented, communicated and implemented across manufacturing nodes
Leading and supporting supplier related technical issues
Support of inspections at manufacturing nodes
Authoring, reviewing regulatory documents and supporting regulatory responses
Authoring, reviewing and approving technical study protocols and reports
Support person-in plant activities for technology transfer and lifecycle management changes
Actively participates in a culture of continuous improvements and process optimization
Providing technical direction in the interpretations of trends observed in process monitoring and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
Encourage and lead in use of digital and data as enabling technologies to achieve company objectives.
Teaching, coaching, mentoring, and learning from team members.
Build trust and develop new relationships with internal and external stakeholders to effectively collaborate and achieve successful outcomes.
Minimum Education Required and Experience:
Bachelor of Science (B.S.) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline with five (5) years of relevant industrial experience OR
Master of Science (M.S.) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline with three (3) years of relevant industrial experience OR
Ph.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry or related life science or engineering discipline with no relevant industrial experience
Required Skills and Experience:
Strong problem-solving skills and a hands-on approach to problem solving.
Project management skills and experience
Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) to best understand and resolve it.
Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.
A strong desire to succeed and to help others to do the same.
Proficiency in the use of Microsoft Office Suite.
Biologics, vaccine, or sterile processing
Cross-functional project leadership
Have a deep understanding of the science and technology behind large molecule manufacturing processes
Have excellent communication skills (both written and verbal), that are required to manage multiple different stakeholders.
Effective multi-tasking skills and the ability to manage multiple stakeholders
Preferred Skills and Experience:
Ability to interact directly with regulatory agencies
Participation in regulatory agency inspections
Understanding of manufacturing / operational GMP (Good Manufacturing Practice)
Experience and knowledge in cell culture with emphasis on mammalian cell culture.
Experience with quality systems, quality risk management, change control, and conducting GMP investigations.
Experience with data analytics, statistical process control and multivariate analysis.
Experience in large-scale validation and process characterization.
Experience in regulatory filing authoring, regulatory inspection support and/or regulatory responses and interactions.
Understanding of analytical methods to characterize biopharmaceutical processes and/or US/EU regulatory requirements
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply todayNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range:$111,400.00 - $175,300.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:50%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:09/21/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Job Posting End Date: 09/21/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID: R313189