06 May
Associate Principal Scientist-Sterile Liquids Commercialization
Pennsylvania, Westpoint 00000 Westpoint USA

Vacancy expired!

Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.The Sterile Liquids Commercialization (SLC) group within our Manufacturing Division is based out of West Point PA. It is the division’s leader in Sterile Product and Process Development, process scale up, technology transfer, and a key enabler of new market authorizations, launch and product life cycle management for all injectables in our Company’s sterile drug products portfolio. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel Vaccines, Biologics and Pharmaceutical products and combination products.The Associate Principal Scientist in Sterile Liquid Commercialization is an experienced drug product commercialization scientist/engineer, accountable for planning and execution of activities associated with commercial design, characterization and transfer for of Sterile Drug Products like Vaccines and Innovative Large Molecules to clinical and commercial manufacturing sites.Primary Responsibilities for this position include but are not limited to the following:

Leads drug product (DP) working group and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support. Develop robust and scalable manufacturing processes while minimizing time to file and launch

Develops a process and product development plan. Responsible for the design and execution of DP development and commercialization studies, new process introduction and validation at commercial sites.

Drives the design and execution of process characterization activities, including oversight of laboratory personnel. Ensures fit-for-purpose scale-down models are developed and employed. Accountable for execution and completion of lab studies. Executes and assists in the lab studies as required to ensure ‘right first time’ and ‘lead by example’

Responsible for commercial site tech transfer and facility fit. Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls and parameter classification

Influences primary packaging decisions. Drives and influences process demonstration and qualification (PPQ) strategy

Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and review regulatory filings.

Establishes and validates platform engineering and scientific models for sterile product and process commercialization.

Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.

Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.

Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.

Serves on cross functional teams and support strategic initiatives.

Leads agile implementation of new/improved business processes in partnership with colleagues in our Company's Research Laboratories and the Merck Manufacturing Division.

Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.

Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.

Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion

Potentially manages a small group of individual contributors (professional and contract employees).

QualificationsEducation:

B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or

Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or

Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience

Preferred Expertise:

Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations

Experience with utilization of QbD principles to process development and life cycle managementExperience in Design of Experiment (DoE) and statistical data analysis.

Experience in authoring and reviewing CMC regulatory documentation.

Analytical problem-solving skills

Financial acumen, experience with forecasting and budgeting of resources

This position may require travel up to 25%; Must be able to travel for this position.Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.INVENT.IMPACT.INSPIRE.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.If you need an accommodation for the application process please email us at staffingaadar@merck.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:Travel Requirements:25%Flexible Work Arrangements:Work WeekShift:Not IndicatedValid Driving License:Hazardous Material(s):Number of Openings:2Requisition ID: R50182

Vacancy expired!


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