MSD
Job title:
Senior Scientist, Downstream Pilot-Scale Lab Lead
Company
MSD
Job description
Job DescriptionThe Bioprocess Drug Substance and Commercialization (BDSC) group within our Manufacturing Division focuses on late-stage drug substance process development, technology transfer, and in-line support for vaccines and biologics. We seek a motivated downstream processing scientist/engineer to work under technical direction of a group leader to support development and licensure of novel large molecule products.Primary ResponsibilitiesLead the hands-on execution of pilot-scale experiments. Typical unit operations include chromatography, ultrafiltration/diafiltration (UFDF), virus filtration, centrifugation, homogenization, and normal flow filtration at the 50L – 500L bioreactor scale.Coordinate staffing, inventory, waste management, equipment upkeep, budget management, data analysis, and documentation. Mentor other scientists as a subject-matter expert in pilot-scale operation.Collaborate with stakeholders across multiple biologics and vaccines programs. Perform facility fit analysis to assess processing requests. Support process investigations, study design, and occasional on-the-floor manufacturing support.Drive organizational excellence practices such as technical standards, process platforms, operational procedures, and laboratory safety.Position Qualifications:Education Minimum Requirement:BS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years relevant experience, orMS in above-listed discipline with 4 years relevant experience, orPhD in above-listed discipline with 0+ year(s) of relevant experienceRequired Experience and Skills:Hands-on experience with one or more of the downstream unit operations mentioned aboveMechanistic understanding of downstream unit operations and scale-up principlesAbility to manage dynamic timelines and prioritiesAbility to effectively scope, assign tasks, and allocate resources for meeting project goalsAbility to independently design and execute experiments in a manner that meets quality expectationsAbility to independently drive continuous improvementWell-developed organizational, record-keeping, and problem-solving skills, with an attention to detailExcellent oral and written communication skills, especially in training othersAbility to foster a collaborative work environment focused on mentorship, coaching, and learningPreferred Experience and Skills:Experience in a downstream pilot-scale and/or manufacturing environmentExperience with process investigations and root cause analysisLaboratory management or team leadership experienceEquipment commissioning and user acceptance testing experienceCurrent Good Manufacturing Practice (cGMP) awareness or experienceAuthoring of technical documentation in support of the following: process performance qualification (PPQ), risk assessment, control strategy, process comparability reports, and/or regulatory submissionsCommunication of scientific information through oral presentations and written documentsNOTICE FOR INTERNAL APPLICANTSIn accordance with 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.Current Employees applyCurrent Contingent Workers applyUS 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 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: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.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, Monday – 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”.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully
Merck & 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: 10%Flexible Work Arrangements: HybridShift: 1st – DayValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 10/24/2024*A 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.
Expected salary
Location
Pennsylvania – Wales
Job date
Fri, 11 Oct 2024 07:19:16 GMT
To help us track our recruitment effort, please indicate in your email/cover letter where (globalvacancies.org) you saw this job posting.