Job DescriptionOur Manufacturing Division is a team of dedicated, energetic individuals who are committed to be 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.As part of Our Company’s Manufacturing Division, within the Large Molecule Science and Technology (LMS&T) organization, the Bioprocess Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of drug substance manufacturing processes for late-stage pipeline and commercial products for biologics (therapeutic proteins) and vaccines. BDSC supports various combinations of commercialization activities, including process development and characterization, laboratory experiment design and execution, technology transfer to internal and external manufacturing sites, process validation, manufacturing investigations and trend analysis, process enhancements, next generation process development, and authoring of regulatory submissions.Under the general scientific and administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage and commercial program activities within BDSC.Scope includes:
Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.
Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.
Provides technical leadership in the interpretations of trends observed in commercial process monitoring and for further technical investigations and process improvement changes.
Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream, analytical, and secondary manufacturing and GMP site readiness.
Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams.
Authors required regulatory and technical documentation. Ensures that processes are developed and documented according to standard practices.
Education Minimum Requirement:
Degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with number of years in related field: 10 years with BS, 8 years with MS, or 4 years with PhD.
Required Experience and Skills:
Technical expertise in purification of biological and/or vaccine molecules, including laboratory models for chromatography or filtration systems.
Experience with technology transfer or scale-up of processes to pilot and manufacturing scales for biologics and/or vaccine manufacture.
Excellent oral and written communication skills. Ability to effectively articulate understanding of purification process science, to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Preferred Experience and Skills:
Deep technical knowledge of harvest, preparative chromatography, tangential flow filtration, and/or normal flow filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations.
Technical operations experience in the manufacture of biological and/or vaccine molecules at the pilot or commercial scale.
Prior experience in late-stage process development, process characterization, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and working with external contract organization for development and or manufacturing.
Working knowledge of statistical methods for DOE design and data analysis (JMP or Design Expert software).
Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics and/or vaccine processes.
Working understanding of analytical methods to characterize biologics and/or vaccines and cGMP US/EU regulatory requirements.
Your role at Our Company 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 Our Company, we're inventing for life.NOTICE 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”.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:$135,500.00 - $213,400.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, 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:YesTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:06/8/2024A 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: 06/08/2024A 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: R295721