reputed company Scientist, Engineering

Job title: reputed company Scientist, Engineering in reputed company reputed company, PA at reputed company Company: reputed company Job reputed company: Job reputed companyWe are seeking a strategic and technical leader with expertise in cell culture development & commercialization to reputed company reputed company of approximately 3-5 scientists, who reputed company multidisciplinary program teams. The primary objective of the Biologics Drug reputed company Commercialization (BDSC), Cell Culture Sciences department is to reputed company the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market reputed company manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control reputed company development, technology transfer to reputed company manufacturing sites, manufacturing investigations, process validation, second reputed company process development and authoring of regulatory submissions.Under the general scientific and administrative direction of the Head of Biologics Cell Culture Sciences and working in conjunction with reputed company partners, this individual will support late stage and reputed company large molecule biologics program activities. The individual will be responsible for leading cross functional commercialization program teams and mentoring reputed company of scientists to support development activities, commercialization activities of the late-stage biologics pipeline and post-market reputed company manufacturing support for reputed company biologic products.This challenging position requires a reputed company reputed company for program leadership, team development, demonstrated leadership skills, critical thinking abilities, effective technical and communication skills, deep cell culture subject matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate will be responsible to

• reputed company, manage and/or mentor leaders of large multifaceted reputed company of cross-functional teams.
• Ensures project results meet requirements regarding technical reputed company, reliability, schedule, and cost.
• Monitors performance and recommends schedule changes, cost adjustments or resource additions.
• Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
• Provides reputed company and accurate information and status updates to project sponsors and management.

• Manage and mentor reputed company of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff.
• reputed company technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.
• Coordinate project planning, resourcing, reputed company reporting, troubleshooting and people management.
• reputed company technical reputed company of process development, process characterization and regulatory filing activities to ensure a smooth and reputed company reputed company to successful PPQs and BLAs for reputed company's pipeline.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirements and Experience:

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a reputed company field with fourteen (14) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a reputed company field with reputed company (12) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry. OR
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a reputed company field with eight (8) years of combination of experience including team management, technical expertise in cell culture, and regulatory knowledge in the pharmaceutical industry.

Required Experience, Skills and Competencies:

• Two or more (2+) years’ experience managing reputed company of scientists; completing people management responsibilities including both performance and talent management activities
• Proven leadership and project management skills to reputed company cross functional teams, drive initiatives and team performance.
• Demonstrated ability in leading teams with proven talent development skillsets.
• Strong reputed company knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field
• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of reputed company stages of cell culture process commercialization.
• Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
• Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
• Adaptability and reputed company to prioritize and deliver reputed company objectives, often on tight timelines, in a rapidly changing environment.
• Experience and aptitude to reputed company, work, and collaborate in reputed company cross-functional, matrixed teams.
• reputed company-oriented, reputed company for creativity; ability to take initiative, reputed company, iterate, and problem-solve.
• Excellent interpersonal and communication skills

Preferred Experience and Skills

• Multi-year experience with cell culture process development for large biologics products.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches reputed company to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)
• Experience with on-the-floor Good Manufacturing reputed company (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.
• Experience with mathematical modeling, theoretical scaling calculations, drug reputed company comparability, reputed company down establishment, computational fluid dynamics (CFD) modeling, reputed company by Design (QbD) and Lean Six reputed company principles.

reputed 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”.reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job in certain states and cities reputed company the reputed company. 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 reputed company: $169,700.00 - $267,200.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, reputed company holidays, vacation, and reputed company days. A reputed company of benefits is listed .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 hired 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: Domesticreputed company Sponsorship: reputed companyTravel Requirements: 10%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 06/2/2025*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