Associate Principal Scientist

Job Description

Position Description:

Associate Principal Scientist

The Sterile and Specialty Products (SSP) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to 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.

Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and Specialty Products.

Primary duties:

• Lead/ contribute towards the new, innovative approaches for biologics 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.

• 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.

• Leads project activities at external manufacturing sites including tech transfers.

• 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.

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

Position Qualifications:

Education Minimum Requirement:

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience.

• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Required Experience and Skills:

• Experienced in biologics process development and characterization particularly for late-stage programs.

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

• 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.

• Track record of working effectively with team-members of diverse skill sets and backgrounds.

• Strong verbal and written communication skills

• 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.

Preferred Experience and Skills:

• 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.

• 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.

• Prior experience with process scales up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred.

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.

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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Expected salary range:

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R268729