Principal Scientist - Sterile And Specialty Products

Attention NJ Applicants: In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

The Sterile and Specialty Products (SSP) group is responsible for developing parenteral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies through commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

We are seeking a highly motivated candidate for a strong candidate for the position of Principal Scientist (R5) within the team focused on developing parenteral drug products of small molecule and/or intermediate modalities. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Primary Duties

• Collaborate with key stakeholders across the organizations (Research Division / Manufacturing Division) to drive key capability evaluations / builds and champion strategic and innovation objectives aligned with organizational goals
• Mentor and/or supervise a small group of scientists to perform the above duties and to develop the above capabilities
• Maintain a strong network internally and across the external academic and regulatory community, and build collaborations across internal company departments and key stakeholders
• Be a seasoned formulation scientist responsible for the design and development of sterile products across injectable, implantable, ophthalmic, and inhaled dosage forms
• Support both early and late-stage development candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings
• Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones

Education

• Ph.D. with a minimum of 7 years industry experience and a degree in Chemical / Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related discipline in process and formulation development

Required Experience And Skills

• Deep drug product development expertise with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background
• Experience with process scale-up, definition of critical attributes, modeling, and technology transfer of early phase and late phase drug product manufacturing processes to GMP production facilities
• Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong understanding of integration and partnering with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas.
• Demonstrated scientific leadership and a strong track record in parenteral formulation and process development (sterile liquid products, lyophilized products, and/or complex systems including long-acting injectables and particle-based delivery systems) reflected through industry experience and external publications and patents
• Excellent verbal and written communication skills, demonstrated initiative, strong interpersonal and collaboration skills, and a strong desire to learn and contribute
• Experience, desire, and a track record of effective mentorship of junior scientists towards timebound goals
• Strong knowledge of QbD principles and experience applying the QbD tools to drug product development, and experience in designing appropriate DOE studies to inform on risks
• Demonstrated experience leading cross-functional teams and driving key capability evaluations and technology selection / builds

Preferred Experience And Skills

• Experience influencing regulatory strategies and a track record of supporting global filings is highly desired
• Experience with intermediate modalities (including oligonucleotides and peptides), non-conventional sterile dosage forms (including ocular and inhaled products), and/or alternate delivery technologies (e.g., high concentration, hydrogels, emulsions, suspensions, injectable depot) is a plus
• Experience on a large capital project team, knowledgeable of the Sterile Standards and equipment design standards, and understanding of project / engineering work process and deliverables (e.g., equipment fabrication, FAT, SAT, qualification / validation) is a plus

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., Rahway, 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.

Residents of Colorado

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected Salary Range

$129,800.00 - $220,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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.

Employee Status

Regular

Relocation:

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Shift

Flexible Work Arrangements:

Valid Driving License

Hazardous Material(s):

Requisition ID:R215033