Associate Scientist, Downstream – Biologics Drug Substance Commercialization

MSD Malaysia; West Point (PA); Hybrid; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement

Paid holidays

Job summary

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is seeking a scientist/engineer for Bioprocess Drug Substance Commercialization to advance late-stage process development and technology transfer for biologics.

You will perform hands-on downstream processing experiments, collaborate with manufacturing and analytical teams, and prepare technical documentation for PPQ and regulatory submissions.

Qualifications

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.
• Experience executing lab activities, including authoring study protocols, planning and performing experiments, data analysis, and writing technical reports.
• Ability to execute experiments independently in a manner that meets quality and timeline expectations.

Responsibilities

• Execute hands-on experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development.
• Collaborate with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities.
• Author and/or review technical documents to support Process Performance Qualification (PPQ) and licensure.

Skills

Lab experimentation

Data analysis

Technical reporting

Communication

Education

Bachelor’s degree or higher in Chemical Engineering, Chemistry, Biology

Tools

PPQ documentation

Downstream processing knowledge

Job description

Job Description We aspire to be the premier research-intensive biopharmaceutical company. Our manufacturing division is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases. We are seeking a motivated scientist/engineer to join our Bioprocess Drug Substance Commercialization (BDSC) group. This role offers an exciting opportunity to work on late-stage process development, technology transfer, and in-line support of biologics.

Responsibilities

• Execute hands-on experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development.
• Collaborate with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities, including on-the-floor support for drug substance manufacturing as needed.
• Author and/or review technical documents to support Process Performance Qualification (PPQ) and licensure.

Qualifications Required

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.
• Experience executing lab activities, including authoring study protocols, planning and performing experiments, performing data analysis, and writing technical reports.
• Ability to execute experiments independently in a manner that meets quality and timeline expectations.
• Well-developed communication, organizational, and problem-solving skills, with an attention to detail.

Preferred Experience

• Preferred Experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.
• Large molecule drug substance technology transfer experience.
• Collaboration with analytical teams, pilot-scale, and/or manufacturing environments.
• Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
• Current Good Manufacturing Practice (cGMP) awareness or experience.

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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 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

The salary range for this role is $71,900.00 - $113,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully 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: No

Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 09/19/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.