Senior Scientist, Preclinical Development (Onsite)

Merck; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Job summary

Merck in Rahway, NJ is seeking a lab-based scientist to design and develop sterile drug products for biologics, including injectables and ophthalmic formulations. You will support both early and late-stage assets, build mechanistic insight into degradation and process space, and document results for regulatory filings.

Responsibilities include developing robust drug product compositions, scalable processing, and primary packaging concepts while leading formulation development activities and

Qualifications

• Masters or Ph.D. in a relevant field for sterile product development (chemistry/biochemistry/biomedical engineering).
• Experience with formulation development, stability, and process understanding is preferred.
• Strong analytical and communication skills with a collaborative mindset.

Responsibilities

• Design and develop sterile products for biologics across injectable and ophthalmic routes.
• Support early and late-stage assets; build mechanistic understanding of degradation and process space.
• Document findings in formulation development reports and regulatory filings; lead cross-functional teams.

Skills

Biochemisty

Bioconjugation

Biologics

Biomolecular Chemistry

Bioprocessing

Design of Experiments (DOE)

Drug Delivery Technology

Drug Formulations

Medicinal Chemistry

Molecular Biology Techniques

Preclinical Research

Process Optimization

Education

Masters with four years or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field

Job description

Job Description

Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for biologics, mixed modalities, vaccines and small 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.

Primary Responsibilities

This is a lab based (on-site) role responsible for designing and developing sterile products for biologics (monoclonal antibodies, fusion proteins, antibody-drug conjugates) drugs for injectable and ophthalmic routes of administration. Support product development of both early and late stage assets while developing mechanistic understanding of the degradation and process design space. Key studies include screening and developing robust drug product composition, developing scalable process and defining primary packaging. Coordinate good practice (GXP) manufacture activities and appropriate compatibility characterization to enable processing of drug product and dosage administration in toxicology and clinical study. Build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports and regulatory filings. Active participation and leadership on formulation development teams and interfacing and collaborating with key stakeholders to drive project milestones

Take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills

Education Requirements

Masters with four years or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field

Experience and Skills

Required

Experience and/or knowledge in one or more of the following:

• Protein Stability
• Protein-Protein/Protein-Excipient Interaction
• Biologic molecule design
• Formulation screening
• Characterization
• Process development or process modeling
• Stability predictive modeling
• Basic understanding of sterile product development

Preferred

Course work in biochemistry, protein design, pharmaceutics, physiology, pharmacokinetics, protein sciences, chemical kinetics, Transport phenomenon, physical pharmacy is highly desirable.

Biologics formulation design/process development, alternative processing approaches, definition of critical attributes for process scale-up, analytical development and Chemistry, Manufacturing and Control filing for sterile dosage forms including ocular dosage forms, peptide therapeutics, and non-conventional drug delivery technologies (e.g. emulsions, suspensions, injectable depot)

Required Skills:

Biochemistry, Bioconjugation, Biologics, Biomolecular Chemistry, Bioprocessing, Clinical Development, Clinical Research, Cross-Functional Teamwork, Design of Experiments (DOE), Drug Delivery Technology, Drug Formulations, Medicinal Chemistry, Molecular Biology Techniques, Preclinical Research, Process Optimization

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 http://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf. 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 http://www.msdprivacy.com/us/en/CCPA-notice/.

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$117,000.00 - $184,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Biohazardous materials

Requisition ID:

R422549