Associate Principal Scientist - Biologics Development & Biopharmaceutics

Job Description

The Biologics Development and Biopharmaceutics group is an integrated team responsible for the development and successful registration of new drug products. Formulation activities focus on the development of non-oral dosage forms spanning preclinical toxicology studies through commercialization. We 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.

Biopharmaceutics scientists lead the preclinical bioperformance characterization of new formulations for all modalities by executing a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico (PBPK) tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community. In summary, the Biologics Development and Biopharmaceutics team is positioned to provide a wholistic approach to the translation of preclinical candidates into drug products.

Our team is looking for a strong candidate for the position of Associate Principal Scientist that has experience in both parenteral formulation development and biopharmaceutics.

The successful candidate will:

• Lead/ contribute towards the new, innovative approaches for biologics and/or small molecule sterile product development through the generation of experimental designs, execution of experimental plans and data analysis

• Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.

• Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.

• Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.

• Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals

• Leads project activities at external manufacturing sites

• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

• Proactively identify key biopharmaceutics risks at each stage of drug product development, conduct hypothesis-based assessment employing an integrated approach, drive the development of in vitro-in vivo relationship and preclinical-to-clinical translation in bioperformance of formulations.

• Develop physiologically-based pharmacokinetic models to facilitate decisions in areas including formulation development, food effect evaluation, in vitro-in vivo correlations and dissolution specification setting

• Leading and participating in both internal and external innovation in the fields of formulation development and biopharmaceutics

• 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

• Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.

• Willing to travel 10%

Education:

• PhD in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering, or related discipline with at least 4 years post-graduation experience in an industry or regulatory agency setting

• Masters in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering, or related discipline with at least 8 years of industry experience.

Required Experience and Skills:

• Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process

• Experience with drug product technologies that can be utilized to develop pipeline assets

• Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process

• The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.

• Demonstrated expertise in development and/or application of in silico (e.g. PBPK models) or in vitro (e.g. dissolution, permeability assays) biopharmaceutics tools. Experience with applying these tools to enable evaluation and selection of formulations is preferred.

• Demonstrated strong verbal as well as written communication skills and ability to work effectively with team-members of diverse skill sets and backgrounds

• Demonstrated self-motivation to take ownership and accountability of issues and drive them to completion.

• Demonstrated ability and creativity in solving tough problems.

• Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas

Preferred:

• Prior experience leading development projects at an enterprise level

• Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor

• Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology or biopharmaceutic realm

• Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.

• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems

• Experience in formulation/process, definition of critical attributes for process scale-up, analytical development and experience with New Drug Application/ Biologics license application filing for non-conventional sterile dosage forms

• Hands-on experience with physiologically-based pharmacokinetic modeling software (e.g. Simcyp, GastroPlus) is highly desired.

• Experience with applying such models to specialized dosage forms (oral and non-oral extended release, pulmonary, others).

• Experience with authoring of regulatory documents

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R210357