Senior Principal Scientist

Merck & Co., Inc. West Point , PA 19486

Posted 4 weeks ago

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.

Position Description:

Vaccine Drug Product Development (VDPD) in West Point, PA is seeking a Senior Principal Scientist (R6) to join our department. The successful candidate will be expected to work as part of a team that is focused on the development of vaccine drug products from preclinical through Phase III with a line of sight to commercialization. The main responsibilities will be to lead, guide, and champion innovative DP formulation and processes across the vaccine modalities.

This will include training of other scientists on the design, execution, and documentation of experiments to evaluate the impact of formulation composition and the drug product manufacturing process on yield and stability of liquid and lyophilized products. Additionally, the candidate will help drive efficiencies throughout the manufacturing process for clinical supply production and design robust processes to enable technology transfer to the commercial sites. The candidate will be responsible to challenge the scientific direction within the space and bring novel and innovative tools to aide in keeping VDPD at the front of vaccine development

The candidate should possess scientific knowledge and / or experience related to various aspects of drug product development (i.e. formulation and process development) of parenteral formulation with a drive to learn new techniques while working at the laboratory bench. The successful candidate will be expected to work within VDPD and across our Company to analyze, coordinate, plan, and lead teams to drive vaccine programs to scale-up and licensure as well as build in novel technologies and external partnerships when required. This position is expected to communicate data both verbally at group meetings and through written documents and reports.

The successful candidate should possess technical knowledge and/or experience related to parenteral process development, scale up, and GMP manufacture. The candidate should be forward thinking and continue to search for the opportunities to gain efficiencies in development and shape the strategy for the organization into the future. The candidate should be working to influence the science and shown to be present externally. This can involve novel approaches to data and analysis, new DP processes, analytics, and formulations, building on novel technologies for delivery and new insights into biology, in vivo/ in vitro correlations will be important. Strong communication skills as well as good documentation practices are essential. The successful candidate will be able to work in a fast-paced team environment.

Position Qualifications:

Education Minimum Requirement:

  • Ph.D. with +8 years or

  • M.S. with +10 years in chemical / biochemical engineering, chemistry, biochemistry or related discipline in process and formulation development

Required Experience and Skills

  • Deep understanding and experience with liquid and lyophilized formulation development for sterile injectables and the development of corresponding drug product manufacturing processes

  • Deep Understanding of the drug product manufacturing process and scale-up considerations. Shown ability to scale-up processes from early space to commercial scale and demonstrated successful Technology Transfer of sterile processes

  • Fill/finish process scale-up and technology transfer experience including the use of gap analysis and risk assessment tools

  • Drug product development experience with large molecule and/or live virus vaccines for parenteral administration

  • Working knowledge and/or experience with lyophilization, including scale up and technical transfer considerations

  • Experience with using engineering principles to design scale up studies and interpreting results

  • Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters

  • Experience with adjuvants, especially with particulate forms of adjuvants (i.e. LNPs, Stable Emulsions etc.)

  • Experience with manufacturing of clinical supplies

  • Demonstrated ability to develop formulation design space and critical process parameters

  • Proven written and verbal communication skills

  • Strong organizational and technical problem-solving abilities

  • Ability to work in a fast-paced team environment

  • Proven ability to lead program development teams using project management skills

Preferred Experience and Skills:
  • Understanding of process related stresses that impact the quality and stability of vaccines

  • Familiarity with Quality by Design (QbD) principles, cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing

  • Advanced computation, data analysis, and visualization skills

  • Process evaluations and troubleshooting skills

  • Willing to mentor and develop scientific staff across vaccines, biologics, and small molecules

  • Strong track record of patent applications / patents

  • Strong track record of external peer-reviewed publications

  • Demonstration of external scientific presence and influence

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

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.

Residents of Colorado

Click here to request this role's pay range.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Shift: 1st - Day Valid Driving License: Hazardous Material(s): Number of Openings: 1 Merck & Co., Inc. West Point PA

Senior Principal Scientist

Merck & Co., Inc.