Principal Scientist, Oral Formulation Sciences
Merck
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Benefits offered by this job
Job summary
Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead CMC formulation development for new chemical entities, guiding first-in-human through market formulations.
You will drive drug delivery strategies, manage cross-functional teams, and advance technology initiatives within PSCS. The role requires an established drug formulation expert with a track record in pilot-to-commercial scale-up, robust DOE practices, and leadership that accelerates pipeline programs while mentoring junior
Qualifications
- PhD with 8+ years industry experience; MS with 10+ years; BS with 14+ years.
- Lead formulation development activities in matrix teams.
- Experience with conventional and novel drug product technologies.
- Strong publication/patent activity and ability to mentor.
Responsibilities
- Lead development of innovative product development approaches and experimental designs.
- Mentor staff and support pipeline programs.
- Coordinate Due Diligence of pipeline assets and cross-functional leadership input.
Skills
Education
Job description
Principal Scientist Job Description: Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.
The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization.
- Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction
- Mentors technical staff to develop team members scientifically and support the execution of pipeline programs
- Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSCS on cross-functional teams to make strategic and technical recommendations to leadership
- Sets direction and coordinates technology development efforts in emerging drug delivery areas
- Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
- Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies
- Is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology
- The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results
- Can independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while also helping to coach others in a collaborative environment
- Coordinate development activities with chemistry, analytical, and physical characterization groups
- Leads project activities at external manufacturing sites
- Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations
- Enhance our company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
- Builds and maintains awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and develop staff across the organization
- Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience.
- M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience.
- B.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 14 years relevant industrial experience.
- Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
- Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across our company
- Extensive experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including hands on experience to independently operate in a pilot plant as well as an in-depth understanding of the science to train others in the department
- Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas
- Has broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process, excipient attributes, and formulation-process interplay
- Demonstrated ability to independently design, execute and lead complex experiments and data analysis
- Track record of working effectively with team-members of skill sets and backgrounds
- Strong verbal and written communication skills
- Prior experience leading development projects at an enterprise level
- Strong mentoring capabilities to build individuals and teams
- Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology
- Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.
- Desire to build new capabilities through the evaluation of new technologies and hands‑on optimization of existing technologies.
- Ability to engage others to build a strong scientific community and address drug delivery challenges.
- Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems
- Adaptability
- Adaptability
- Biomedical Engineering
- Cell Culture Process Development
- Cell Line Development
- Chemical Engineering
- Combination Products
- Data Analysis
- Design of Experiments (DOE)
- Drug Delivery
- Drug Formulations
- External Manufacturing
- Finite Element Analysis (FEA)
- Innovative Thinking
- Leadership Mentoring
- Life Cycle Planning
- Manufacturing Processes
- Manufacturing Strategies
- Manufacturing Technologies
- Matrix Management
- Perform Testing
- Pharmaceutical Process Development
- Pharmaceutical Process Engineering
- Pharmaceutical Sciences
- Pilot Projects {+ 10 more}
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is $173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Regular
Not Applicable
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R412813
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