Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)

Job Description

Are you ready to make a significant impact in the world of biopharmaceuticals purification? At our company, we are at the forefront of innovation in the Manufacturing Division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality. Join us and be part of a team that uses leading-edge science to save and improve lives around the world.

The Associate Principal Scientist (Associate Director) provides technical and scientific leadership to advance late-stage and commercial biologics from development into reliable manufacturing. This role is responsible for designing, scaling, and transferring purification processes that ensure biological drug substances are produced safely, consistently, and in compliance with regulatory requirements. By partnering closely with process development, manufacturing, quality, and regulatory teams, the Associate Principal Scientist helps establish robust control strategies that support product licensure and long-term commercial success.

Responsibilities

• Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes.
• Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization.
• Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
• Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
• Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
• Author regulatory and technical documentation, ensuring all processes align with our company’s expectations.
• Manage a small team of junior staff, guiding them in their professional development.

Qualifications

Required

• A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience: Ten (10) years of required experience with a bachelor's degree, Eight (8) years with a master's degree, and Four (4) years with a PhD.
• Proficient in the purification of biological molecules, including chromatography and filtration systems.
• Proven track record in tech transfer or scaling up processes for biologics manufacture.
• Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment.
• Experience leading teams and fostering career development for junior staff.

Preferred

• In-depth knowledge of harvest, preparative chromatography, and filtration techniques.
• Experience in pilot or commercial scale manufacturing of biological molecules.
• Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.
• Proficiency in statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA).

Required Skills:

Adaptability, Adaptability, Biochemical Analysis, Biological Engineering, Biomedical Engineering, Bioprocessing, Chemical Engineering, Chromatographic Analysis, Chromatographic Techniques, Chromatography, Clinical Process, Cross-Functional Collaboration, Data Analysis, Decision Making, Detail-Oriented, Downstream Operations, Downstream Processing, Foster Innovation, Leadership, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements {+ 7 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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:

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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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). 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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/25/2026

*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.