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Principal Scientist

Requisition ID: PRE000685

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its¬ legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.¬ 



The Analytical Sciences group in Rahway has an opening for a Principal Scientist with a strong background in drug product development. Join us and experience our culture first-hand ‚€” one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health.¬  As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.



In your role as Principal Scientist, you will lead a small team of Analytical scientist and be responsible for the support of pharmaceutical product development and regulatory submissions. In addition, you will contribute to the department's efforts towards effective collaboration with internal stakeholders, building strategic external partnerships, and to identify and recruit new and innovative technologies to solve complex problems.



Your main responsibilities, which are in no particular order and are by no means complete, include:




  • Scientific leadership in support of small molecule, peptide, and oligonucleotide formulation development in both solid oral and sterile dosage forms

  • Planning and successful execution of analytical strategies to support formulation development, product characterization and mitigating any technical risks

  • Authoring / reviewing¬  IND, IMPD, and NDA / WMA submissions as well as responses to agency questions

  • Strong collaboration with internal stakeholders and external vendors¬  ¬ 

  • Analytical leadership support to drug development and innovative technology teams

  • Presentation of study results to project teams, stakeholders and internal governance bodies

  • Leading and Mentoring scientific staff¬ 

  • Representing Analytical Sciences on teams evaluating new external technologies and potential licensing opportunities¬ 

  • External engagement especially with a focus on regulatory strategy development related to small and large molecule containing drug products¬ 

  • Efficient communication with external partners via consortia and / or scientific collaborations with academic institutions



This is an exciting opportunity for an enthusiastic scientist with a clear understanding of the technical and regulatory challenges of developing complex formulations and who has excellent communication skills.¬  Experience leading scientific professionals would be ideal.¬ 


Qualifications

¬ Education Minimum Requirement:




  • Ph.D Degree in Organic, Physical or Analytical Chemistry or related degree plus 8+ years of relevant industry experience.

  • Master's Degree with 10+ years of relevant industry experience

  • Bachelor's Degree with 14+ years of relevant industry experience¬ 



Required Experience and Skills:




  • This role requires a College/University (graduate school) degree in Organic, Physical or Analytical Chemistry, pharmaceutical sciences or equivalent with extensive experience in pharmaceutical development.¬ 

  • A proven record of strong technical problem solving skills and advanced knowledge of regulatory requirements in drug product development along with excellent communication and interpersonal skills are necessary to be considered for this role.¬ ¬ 



Preferred Experience and Skills:




  • The applicant should have experience leading scientific staff.¬ 

  • Some experience in large molecule development (i.e. peptides, nucleotides), dissolution characterization, and knowledge in statistical data processing is a plus.¬ 



Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.¬ 


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If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.


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Search Firm Representatives Please Read Carefully:¬ 


Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.¬  Please, no phone calls or emails.¬  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.¬  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


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


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¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC Poster


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC GINA Supplement¬ 


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  OFCCP EEO Supplement


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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ‚€“ proudly embracing diversity in all of it's manifestations.

Job: Preclinical Dev Generic
Other Locations: West Point, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck

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