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Job Description

As part of Our Company’s Manufacturing Division, within the Biologics Science and Technology organization, Biologics Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and commercial drug substance manufacturing processes for biologics. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) as part of the various pipeline commercialization activities, including process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.

We are seeking a strategic and technical leader with expertise in biologics purification process development & commercialization to lead a team of approximately 15-20 scientists in Rahway NJ, enabling them to lead multidisciplinary program teams and execute laboratory activities.

Under the general scientific and administrative direction of the Head of Downstream Biologics Drug Substance Commercialization team, this individual will support late stage and commercial large molecule programs with a focus on biologics downstream processing, including multi-specific antibody therapeutics, antibody-drug conjugates (ADCs), among other complex biologics modalities. The individual will manage a team of 15 – 20 downstream scientists and will ensure that BDSC delivers an outstanding level of rigor in our scientific work and manufacturing support activities.

A successful candidate in this role would:

+ Lead downstream and/or overall drug substance teams focusing on late-stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.

+ Drive division wide initiatives that will enable our Company's biologics manufacturing strategic goals.

+ Provide technical leadership for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigations, including studies performed either in-house or externally.

+ Focus primarily on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and GMP site readiness.

+ Actively interact with internal and external partners. Represents functional area on cross-functional and cross-divisional teams to identify solutions to technical and business problems.

+ Manage and/or mentor leaders of large multifaceted projects of cross-functional teams.

+ Provide timely and accurate information and status updates to project sponsors and management.

+ Solve technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.

+ Ensure project results meet requirements regarding technical quality, reliability, schedule, and cost.

+ Author required regulatory and technical documentation. Ensure that process/product are developed and documented according to standard our Company practices.

+ Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Education Minimum Requirement:

+ BS, MS or PhD in Chemical Engineering/Biological Engineering/Chemistry with a minimum of 14 years (for BS), 12 years (for MS), or 8 years (PhD) relevant industry experience including team management, technical expertise in downstream biologics purification, and regulatory knowledge in the biopharmaceutical industry.

Required Experience and Skills:

+ Proven track record of biologics drug substance development and commercialization and manufacturing science & technology.

+ Strong fundamental knowledge and subject matter expertise in downstream processing of biologics and working knowledge of upstream & analytics.

+ Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.

+ Expertise in independently conducting and directing the design, execution, analysis, and documentation for all stages of process development.

+ Proven leadership and project management skills to drive initiatives and team performance.

+ Knowledge and experience of biologics commercialization

+ Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.

+ Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.

+ Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.

+ Demonstrated commitment to coach and mentor staff to maximize talent development and utilization.

+ Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

Preferred Experience and Skills:

+ Leadership in drug substance working group team.

+ People management experience

+ Experience with technology transfer (scale-up and validation) of processes to pilot and manufacturing scales for biologics manufacture.

+ In-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.

+ Prior experience with developing multi-specific antibody therapeutics, including a wide variety of bispecific or multi-specific antibody formats.

+ Prior experience in late-stage process development, process characterization including viral clearance studies, process performance qualification and validation, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.

+ Working knowledge of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus.

+ Working knowledge of statistical methods for DOE design, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.

+ Demonstrated experience in lean leadership/operational excellence with applicability to functional area (e.g. labs) or manufacturing processes.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

$169,700.00 - $267,200.00

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 (https://www.benefitsatmerck.com/) .

**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/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Analytical Tools, Analytical Tools, Antibody Drug Conjugates (ADC), Antibody Therapeutics, Applied Engineering, Biopharmaceutical Industry, Biopharmaceuticals, Business, Cell-Based Assays, Cell Cultures, Change Agility, Clinical Process, Communication, Consulting, Cross-Cultural Awareness, Cross-Functional Team Leadership, Digital Transformation Initiatives, Downstream Process Development, Downstream Processing, Engineering Standards, Estimation and Planning, Lean Leadership, Maintenance Supervision, Mammalian Cell Culture, Management Process {+ 19 more}

Preferred Skills:

Job Posting End Date:

05/24/2025

*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:** R348967