Associate Principal Scientist - Biologics Development & Biopharmaceutics
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%
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
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.
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Expected salary range:$106,600.00 - $181,400.00
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