Associate Principal Scientist, Engineering

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our 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.

Associate Principal Scientist, Sterile Liquid Commercialization

Job Description

The Sterile Liquid Commercialization (Manufacturing Science and Technology) group within our 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. The department is a key enabler of new market authorizations and product launches, while providing technical sponsor and product life cycle management for all injectables in our sterile drug products portfolio. The group is accountable for establishing the science, engineering and knowledge needed 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 a knowledgeable 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.

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

• 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 promotion. 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 product introduction and process 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. Accountable 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 promotes 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 regulations 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 sponsor strategic initiatives.

• Directs agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the 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 colleagues (professional and contract employees).

Education

B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant industry knowledge; or Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant industry knowledge; or

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

Preferred knowledge and Skills

• Knowledge of combination product development Knowledge in Good Documentation Practices (GDPs).

• Working knowledge of current Good Manufacturing Practices (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 principles to process development and life cycle management.

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

• Authoring and reviewing CMC regulatory documentation.

• Analytical problem-solving skills.

• Project management and activities management skills (dashboards, activity trackers).

• Operations knowledge in the manufacturing of sterile drug products, at pilot and/or commercial scale.

• Biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.

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

• Competency in technical writing.

• Excellent stakeholder management and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

• Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).

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.

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In 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.

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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.

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Requisition ID:R138775