Job Description
As part of Our Company’s Manufacturing Division, within the Large Molecule Science and Technology (LMS&T) organization, the Bioprocess Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of drug substance manufacturing processes for late-stage pipeline and commercial products for biologics (therapeutic proteins) and vaccines. BDSC supports various combinations of commercialization activities, including process development and characterization, laboratory experiment design and execution, technology transfer to internal and external manufacturing sites, process validation, manufacturing investigations and trend analysis, process enhancements, next generation process development, and authoring of regulatory submissions.
Under the general scientific and administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage and commercial program activities within BDSC.
Scope Includes
- Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.
- Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring and for further technical investigations and process improvement changes.
- Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream, analytical, and secondary manufacturing and GMP site readiness.
- Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams.
- Authors required regulatory and technical documentation. Ensures that processes are developed and documented according to our Company standard practices.
Education Minimum Requirement
- Degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with number of years in related field: 10 years with BS, 8 years with MS, or 4 years with PhD.
Required Experience And Skills
- Technical expertise in purification of biological (including complex multi-specific antibody variants) and/or vaccine molecules, including laboratory models for chromatography or filtration systems.
- Experience with technology transfer or scale-up of processes to pilot and manufacturing scales for biologics and/or vaccine manufacture.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of purification process science, to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Preferred Experience And Skills
- Deep technical knowledge of harvest, preparative chromatography, tangential flow filtration, and/or normal flow filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations.
- Technical operations experience in the manufacture of biological (including complex multi-specific antibody variants) and/or vaccine molecules at the pilot or commercial scale.
- Prior experience in late-stage process development, process characterization, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and working with external contract organization for development and or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (JMP or Design Expert software).
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics and/or vaccine processes.
- Working understanding of analytical methods to characterize biologics and/or vaccines and cGMP US/EU regulatory requirements.
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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.
Requirements
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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US Salary Range
$139,600.00 - $219,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
05/2/2025
- 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.
Requisition ID:R334336
