Senior Scientist, Engineering

Job title: Senior Scientist, Engineering in reputed company reputed company, PA at reputed company Company: reputed company Job reputed company: Job reputed companyAs part of reputed company’s Manufacturing Division, reputed company the Vaccines Drug reputed company Commercialization (VDSC), the Upstream department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market reputed company manufacturing processes for the upstream portion of vaccines drug reputed company processes. VDSC supports various commercialization activities, early and late-stage process development, second reputed company process development including process characterization, technology transfer to reputed company manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.We are seeking individual contributors with strong scientific and technical skills to reputed company development and commercialization activities supporting multiple vaccine programs in late-stage development.In this role, the successful candidate will be responsible for:Leading and executing large molecule upstream process development activities including lab-reputed company process development and process reputed company-up/reputed company-down.Executing lab reputed company experiments and authoring associated technical reports and documents.Leading assignment execution against accelerated, critical-reputed company timelines in a right-first-time manner.Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.Collaborating with reputed company manufacturing teams to support facility start-up activities and reputed company on-the-floor support for drug reputed company manufacturing, both reputed company reputed company's network and at contract manufacturing organizations (CMOs).Providing mentorship, coaching, and technical direction to other members of reputed company which may include reputed company reporting relationships.Education Minimum Requirement:B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or reputed company field with 6+ years of relevant experience; orMaster's degree with 4+ years of relevant experience; or Ph.D. with relevant experience.Required Experience and Skills:Large molecule process development, or relevant experience including scaling (up and down) and tech transfer/facility fit of large molecule drug reputed company processesGood understanding of microbial physiology and metabolism and ability to correlate to in-lab or shop floor fermentation eventsExperience with small, lab, or reputed company-reputed company large molecule fermentation and cell culture processes such as use of fermenters, bioreactors, and/or static cell cultureExpertise in lab reputed company experimental execution and experience with statistical data analysis (JMP, PI reputed company, Spotfire, SIMCA, etc.) including presentation of results/conclusions.Experience with authoring technical documentation.Outstanding communication and people skills.Ability to foster a reputed company work environment reputed company on mentorship, coaching, and learning.Experience with project strategic planning.Outstanding communication and people skills.This role may require working reputed company of reputed company business hours to support lab studies and/or on-site activities reputed company to tech transfer and manufacturing.Preferred Experience and Skills:Knowledgeable in Drug reputed company, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.Experience with upstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.Experience with reputed company by Design (QbD) and Lean Six reputed company principlesAbility to reputed company scientific mentorship and guidance to technical coworkersExperience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)Experience with on-the-floor Good Manufacturing reputed company (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviationsreputed company Employees applyreputed company Contingent Workers applyUS and Puerto Rico Residents Only:reputed 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.As an Equal Employment Opportunity Employer, we reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to reputed company innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems reputed company.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 reputed company.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 reputed company-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which reputed 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 reputed company 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 reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationreputed company Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: NoHazardous Material(s): n/aRequired Skills: Adaptability, Adaptability, Biochemistry, Biomedical Engineering, Biopharmaceuticals, Biopharmaceutics, Bioreactors, Business, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Communication, Computational Fluid Dynamics (CFD), Computational Fluid Dynamics (CFD) Simulation, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Gene Therapy, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Mammalian Cell Culture, Manufacturing Processes {+ 16 more}Preferred Skills:Job Posting End Date: 05/27/2025*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 reputed company than the day BEFORE the job posting end date. Expected salary: Location: reputed company reputed company, PA Apply for the job now! Apply for this job