Sr. Spclst, Engineering - Projects - Military Veterans

Job Description

Job Description:

As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for biologically derived drug substances (e.g., therapeutic proteins, antibody drug conjugates, or vaccines) generated from bioconjugation processes.

For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.

In this role, the successful candidate will be responsible for:

• Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance processes.
• Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and regulatory filings for the company's pipeline.
• Leads or coordinates cross-functional project/program teams from technology transfer to filing of commercial process with regulatory agencies.
• Coordinate project planning, resourcing, staffing, supply and subcontract management, progress reporting, troubleshooting and people management.
• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
• Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.
• Monitors performance and recommends schedule changes, cost adjustments or resource additions.
• Solves technical and non-technical problems throughout the life of the project, resolves problems during the design and planning phases whenever possible.
• Provides timely and accurate information and status updates to project sponsors end users, functional leaders and management.
• Participates in budget development and evaluating how project plan changes impact cost and schedule.
• Will oversee and coordinate work performed by others.
• May be responsible for managing large multifaceted projects as the leader of a cross-functional team.

This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing. This role may also require approximately 25% of time spent on domestic (e.g. to Rahway, NJ site) or international travel.

Education & Experience:

Required Education and Experience :

• Bachelor's Degree in Engineering, Science or related field with a minimum of 10 years of relevant experience; or Master's Degree with a minimum of 8 years of relevant experience; or Doctoral Degree (Ph.D) with 4 years of experience.

Required Skills :

• Experience with large molecule manufacturing processes including on-the-floor GMP manufacturing support
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors
• Ability to coach others and manage medium and large multidisciplinary teams effectively
• Ability to drive deliverables to completion and achieve required project timelines
• Possesses outstanding communication skills
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving
• Experience designing process development experiments using risk-based methodology or similar
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization
• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other regulatory source documentation.

Preferred Skills:

• Experience with bioconjugation processes or antibody drug conjugates
• Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites
• Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar

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.

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:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/4/2025
*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.