Job Description
As part of Our Company's Manufacturing Division, the Bioprocess Drug Substance Commercialization (BDSC) department's Bio-Separation Sciences (BSS) team provides the technical downstream process leadership and laboratory capabilities in support of late-stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics. BDSC supports second generation process development and various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the general scientific and administrative direction of the BSS Director, this individual will support late-stage and commercial large molecule programs with a focus on live viral vaccines downstream processing. The individual will manage a team of downstream scientists and will ensure that BDSC delivers an outstanding level of rigor in our scientific work and manufacturing support activities.
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Technical Scope
- Leads 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.
- Drives division-wide initiatives that will enable our Company's vaccine manufacturing strategic goals.
- Provides 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.
- Primary focus will be 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 interacts with internal and external partners. Represents functional area on cross-functional and cross-divisional teams.
- Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard our Company practices.
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.
Required Experience and Skills:
- Strong fundamental knowledge and subject matter expertise in downstream processing of vaccines
- Expertise in independently conducting and directing the design, execution, analysis, and documentation for all stages of process development.
- Knowledge and experience of vaccines 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 teams
- People management experience
- Experience with technology transfer (scale-up and validation) of processes to pilot and manufacturing scales for vaccines manufacture.
- In-depth knowledge of harvest clarification, preparative chromatography, and tangential flow filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Prior experience in late-stage process development, process characterization including process performance qualification and validation, authoring regulatory BLA sections, and/or working with external contract organizations for development and or manufacturing.
- Working understanding of analytical methods to characterize vaccines and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus.
- Demonstrated experience in lean leadership/operational excellence with applicability to functional area (e.g. labs) or manufacturing processes.
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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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".
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:
11/17/2024
*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:R322088