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Job Details


Merck & Co. Inc.

Principal Scientist, Sterile Liquids Commercialization

Pharmaceuticals

All

Full Time

On Site

No

West Point, Pennsylvania, United States

Job Description

The Sterile Liquids Commercialization (SLC) group within our Company's Manufacturing Division is based out of West Point PA. It is the division’s principal 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. The group is accountable for establishing the science, engineering, and knowledge for today’s innovative and accelerated commercialization of novel Vaccines, Biologics and Pharmaceutical and combination products.

The Principal Scientist in Sterile Liquids Commercialization is a senior technical principal, reporting directly to the Director of SLC.

Accountabilities and tasks for this position include but are not limited to the following:

  • Develop robust lyophilization cycles which can be tech transferred to the DP commercial manufacturing site.

  • Design and execute studies to characterize lyophilization cycle.

  • Directs 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 sponsorship. Develop robust and scalable manufacturing processes while minimizing time to file and launch

  • Develops a process and product development plan. Accountable 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 to ensure ‘right first time’ and ‘lead by example’

  • Accountable for commercial site tech transfer and facility fit. Reliable 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 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 standards 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 established.

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

  • Serves on cross functional teams and promotes strategic initiatives.

  • Directs agile implementation of new/improved business processes in partnership with colleagues in our Research & Development Division and our Company's 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 knowledge 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).

Qualifications

Education:

  • B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 14 years of relevant knowledge; or Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant knowledge; or Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant knowledge

Preferred Expertise:

  • Manufacturing or developing lyophilized products

  • Lyophilization cycle development

  • Manufacturing of sterile drug products (vaccines, biologics) at pilot or commercial scale. Manufacturing Science and Technology applications, Sterile Process Manufacturing Modernization, and Improvements

  • Data Analytics applications, Computational modeling, Digitalization applications

  • 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.

  • Utilization of QbD standards to process development and life cycle management

  • Authoring and reviewing CMC regulatory documentation.

  • Financial acumen, forecasting and budgeting of resources

  • Design of Experiment (DoE) and statistical data analysis.

  • Ability to travel for this position (up to 30%)

Our Manufacturing & Supply Division is dedicated to being the most relied on supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with [Register to View] 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.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [Register to View] if you need an accommodation during the application or hiring process.

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R132971